List of Excipients in Branded Drug ALL DAY ALLERGY

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	FD&C YELLOW NO. 6
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	GELATIN
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	GLYCERIN
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	MANNITOL
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	POLYETHYLENE GLYCOL
The Kroger Co	ALL DAY ALLERGY	cetirizine hcl	30142-211	SODIUM HYDROXIDE

Generic Drugs Containing ALL DAY ALLERGY

Company	Ingredient	NDC	Excipient
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	BUTYLATED HYDROXYTOLUENE
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	GELATIN
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	GLYCERIN
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	MANNITOL
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	POLYETHYLENE GLYCOL 400
Rite Aid Corporation	cetirizine hydrochloride	11822-0980	SODIUM HYDROXIDE

What are the Most Frequently-Used Excipients in ALL DAY ALLERGY?

# Of NDCs	Excipient
3	BUTYLATED HYDROXYTOLUENE
3	CELLULOSE, MICROCRYSTALLINE
2	FD&C BLUE NO. 1
1	FD&C BLUE NO. 1 ALUMINUM LAKE
5	GELATIN
3	GLYCERIN

All Day Allergy Excipient Strategy and Commercial Opportunities

Last updated: August 24, 2026

All Day Allergy is an over-the-counter cetirizine hydrochloride product positioned around once-daily allergy relief. Its commercial opportunity is primarily formulation-led, not patent-led. Cetirizine is a mature small-molecule antihistamine, and the strongest growth routes are differentiated dosage forms, allergen-sensitive excipient profiles, pediatric delivery, private-label expansion, and combination products.

The core product strategy should preserve the low-cost economics of a 10 mg immediate-release tablet while creating premium variants through lactose-free, dye-free, sugar-free, rapidly disintegrating, liquid, chewable, and unit-dose formats.

What is All Day Allergy and which active ingredient does it contain?

All Day Allergy products generally contain cetirizine hydrochloride, an H1 antihistamine used for temporary relief of symptoms associated with hay fever, seasonal allergic rhinitis, and indoor or outdoor allergies. The standard adult strength is 10 mg once daily.

Product attribute	Typical All Day Allergy positioning
Active ingredient	Cetirizine hydrochloride
Common strength	10 mg
Therapeutic class	Second-generation H1 antihistamine
Dosage form	Film-coated tablet; other branded or private-label formats may include liquid gels, chewables, or oral solution
Route	Oral
Dosing frequency	Once daily
Regulatory status	OTC drug product
Primary competitors	Zyrtec, generic cetirizine, Claritin, Allegra, store-brand allergy products
Core consumer promise	24-hour allergy relief
Patent dependence	Low for the base cetirizine product

FDA labeling for cetirizine products identifies temporary relief of runny nose, sneezing, itchy or watery eyes, and itching of the nose or throat as core indications.[1]

What excipients are used in All Day Allergy tablets?

The inactive-ingredient profile depends on the specific manufacturer, National Drug Code, dosage form, and package configuration. Public labels for cetirizine tablets commonly include microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, povidone, talc, and coating materials.[2]

Excipient category	Common examples in cetirizine tablets	Functional purpose
Diluent	Lactose monohydrate, microcrystalline cellulose	Adds bulk and improves tablet compression
Disintegrant	Croscarmellose sodium	Promotes tablet breakup after ingestion
Lubricant	Magnesium stearate	Reduces sticking and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow
Binder	Povidone	Supports granule and tablet strength
Anti-adherent	Talc	Reduces punch and die sticking
Film coating	Hypromellose, titanium dioxide, polyethylene glycol, triacetin, or similar materials	Improves appearance, swallowability, and moisture protection
Colorant	Product-specific pigments or dyes	Provides product identification
Liquid vehicle	Purified water, glycerin, sorbitol, propylene glycol, or similar materials	Solubilizes or suspends cetirizine
Liquid preservation system	Product-specific preservative	Controls microbial growth in multidose liquids
Flavor system	Fruit or sweet flavor	Improves pediatric and consumer acceptance

A commercial assessment should treat each All Day Allergy SKU separately. A tablet, liquid gel, chewable tablet, oral solution, and orally disintegrating tablet may have different excipient risks, manufacturing sites, regulatory filings, and competitive positions.

How should an excipient strategy be designed for All Day Allergy?

The base tablet should prioritize low cost, robust compression, rapid disintegration, and broad consumer tolerance. A premium portfolio should then use excipients to address specific consumer segments.

1. Lactose-free tablets

Lactose is common in low-cost tablet formulations, but lactose-free positioning can broaden use among consumers who avoid dairy-derived excipients or associate lactose with gastrointestinal intolerance.

Suitable replacements include:

• Microcrystalline cellulose
• Mannitol
• Dibasic calcium phosphate
• Pregelatinized starch
• Coprocessed excipient systems

Mannitol has a clean-mouthfeel advantage in chewable and orally disintegrating products. Microcrystalline cellulose is more cost-efficient for standard compressed tablets. Calcium phosphate can improve hardness but may alter mouthfeel and compression behavior.

A lactose-free tablet should be marketed as an excipient and dietary preference benefit, not as a claim that cetirizine is clinically superior.

2. Dye-free and titanium-dioxide-free variants

Dye-free products address consumers who avoid artificial colors and simplify retailer assortment for sensitive-consumer segments. Titanium-dioxide-free coating systems can support broader clean-label positioning in some markets.

The principal development issue is visual identification. Removing colorants increases the need for:

• Distinct tablet shape
• Debossed markings
• High-contrast imprinting
• Packaging-level differentiation
• Strong moisture and light protection

Color removal can also affect coating opacity, film uniformity, and brand recognition. A white or off-white tablet is commercially viable if blister and bottle graphics provide clear product identification.

3. Sugar-free liquid and chewable products

Sugar-free liquids and chewables are attractive for pediatric, diabetic, and calorie-conscious consumers. Suitable sweetener systems may include sorbitol, xylitol, sucralose, acesulfame potassium, or combinations of these materials.

The formulation must control:

• Sweetener-induced gastrointestinal effects
• Hygroscopicity
• Taste masking
• Cetirizine bitterness
• Suspension settling
• Preservative compatibility
• Microbial stability

Sorbitol and xylitol can create gastrointestinal tolerance issues at higher intake levels. A low-volume, concentrated oral solution can reduce excipient load but requires accurate dosing and effective taste masking.

4. Rapid-dissolve and orally disintegrating tablets

A rapidly disintegrating dosage form can support premium pricing and on-the-go use. The opportunity is strongest for consumers who have difficulty swallowing conventional tablets or prefer water-free administration.

Relevant excipient systems include:

• Mannitol for cooling sensation and mouthfeel
• Crospovidone or croscarmellose sodium for fast disintegration
• Low-substituted hydroxypropyl cellulose for tablet structure
• Flavor and sweetener systems for bitterness control
• Porous or spray-dried excipient platforms for rapid wetting

The main technical risk is mechanical fragility. Orally disintegrating tablets often require specialized packaging, including aluminum-aluminum blisters or high-barrier unit-dose pouches. Packaging costs can materially reduce the margin advantage over standard tablets.

5. Liquid gels and soft capsules

Liquid gels can provide a premium visual and tactile format, but they create greater manufacturing complexity than compressed tablets. The formulation must address cetirizine solubility, fill-volume consistency, shell compatibility, and long-term migration of formulation components into the gelatin or non-gelatin shell.

Potential commercial benefits include:

• Easier swallowing
• Strong differentiation from commodity tablets
• Premium shelf placement
• Unit-dose portability

The commercial case is weaker if the liquid gel has no meaningful consumer benefit beyond appearance. The product must justify its price through swallowability, dose convenience, or a superior sensory profile.

What formulation patents protect All Day Allergy?

The base cetirizine molecule is a mature generic active ingredient. The principal commercial protection for standard All Day Allergy tablets is therefore branding, regulatory compliance, manufacturing scale, retailer access, and supply reliability rather than a blocking composition-of-matter patent.

Protection category	Relevance to All Day Allergy
Cetirizine composition-of-matter patent	Historical protection; not a meaningful current barrier for standard OTC cetirizine
Standard immediate-release tablet	Generally vulnerable to generic and private-label competition
Specific excipient composition	Potential protection if novel, non-obvious, and supported by performance data
Orally disintegrating formulation	Potentially protectable through composition, manufacturing process, or performance limitations
Taste-masked liquid	Potential formulation and process protection
Modified-release product	Possible patent opportunity, but requires clinical and regulatory support
Packaging system	Possible design or utility protection; usually a weaker barrier than formulation patents
Brand name and trade dress	Trademark and commercial protection rather than patent protection
Manufacturing process	Potential trade-secret or process-patent value

A new excipient formulation would need more than a routine substitution of lactose with microcrystalline cellulose. The strongest patent position would link the excipient selection to measurable technical results, such as faster disintegration under defined conditions, improved stability at high humidity, lower friability, enhanced taste masking, or improved dissolution after storage.

When does All Day Allergy lose exclusivity?

All Day Allergy does not depend on a conventional branded-drug exclusivity timeline in the same way as a newly approved prescription product. Cetirizine has long been available as a generic and OTC ingredient. The relevant competition is from generic cetirizine products, store brands, retailer-owned labels, and established allergy brands.

Zyrtec was originally approved as a prescription product and later converted to OTC status. FDA approved the OTC switch for Zyrtec in 2007.[3] That switch accelerated broad consumer access and expanded the competitive market.

Milestone	Commercial impact
Original cetirizine prescription approval	Established clinical and regulatory basis
OTC switch in 2007	Expanded self-care access
Broad generic availability	Reduced active-ingredient differentiation
Store-brand expansion	Increased price pressure
Private-label manufacturing	Shifted competition toward cost, supply, and retailer economics
New dosage-form launches	Reopened premium differentiation opportunities

What is the Orange Book status of All Day Allergy?

All Day Allergy is generally sold as an OTC product rather than as a conventional prescription NDA product. The Orange Book is therefore not the primary source for evaluating its commercial exclusivity.

For an OTC monograph product, the relevant regulatory framework includes:

• The applicable FDA OTC monograph or final administrative order
• Drug Facts labeling
• Active-ingredient requirements
• Inactive-ingredient controls
• Current good manufacturing practice requirements
• Product-specific registration and listing obligations

FDA’s OTC monograph system permits compliant products to be marketed without an individual premarket approval application when the product meets the applicable conditions.[4] A formulation that falls outside the monograph, introduces a novel active ingredient, or makes unsupported therapeutic claims may require a different regulatory pathway.

Are Paragraph IV challenges relevant to All Day Allergy?

Paragraph IV litigation is generally not the central risk for a standard All Day Allergy OTC product. Paragraph IV certifications apply to ANDA applicants challenging patents listed for an approved prescription drug in the Orange Book. A conventional OTC monograph cetirizine product does not usually create the same listed-patent framework.

Paragraph IV risk could become relevant if a company commercializes:

• A prescription-strength reformulation under an approved NDA
• A novel extended-release cetirizine product
• A combination product with listed patent protection
• A prescription product with formulation or method-of-use patents
• An OTC product associated with an NDA and Orange Book listings

For the standard 10 mg immediate-release product, competitive entry risk is driven more by manufacturing economics and retailer procurement than by Paragraph IV litigation.

What method-of-use patents protect cetirizine products?

Standard allergy-relief use is a mature indication and provides limited differentiation for All Day Allergy. A method-of-use patent could be relevant to a novel use, dosing schedule, patient subgroup, or combination regimen, but such protection would need a distinct regulatory and clinical basis.

Potential areas of research interest include:

• Pediatric dosing optimization
• Nighttime versus daytime administration
• Use in specific allergic conditions
• Combination treatment with intranasal corticosteroids
• Adherence-focused dosing regimens
• Delivery systems designed for patients with dysphagia

A method-of-use claim cannot reliably protect the ordinary consumer use of once-daily cetirizine for seasonal allergy symptoms. The commercial value of such a patent would depend on whether the claimed use supports a differentiated label and whether competitors can practice the same treatment outside the claim scope.

How strong is the All Day Allergy patent estate?

The patent estate for the base product is weak as a barrier to entry and potentially moderate for a genuinely differentiated reformulation.

Factor	Assessment
Active ingredient exclusivity	Low
Standard tablet formulation	Low
Brand protection	Moderate, subject to trademark scope
Retailer relationships	Moderate to strong
Manufacturing scale	Strong where supported by reliable supply
Novel dosage-form protection	Potentially moderate
Novel excipient combination	Potentially moderate if supported by technical data
Biosimilar protection	Not applicable
Generic substitution risk	High
Private-label substitution risk	High

The most defensible intellectual-property strategy would combine:

1. A formulation patent covering a differentiated excipient system.
2. A process patent covering manufacture or coating.
3. Trade secrets covering taste masking, granulation, and stability controls.
4. Trademark protection for the product family.
5. Packaging and trade-dress protection.
6. Retailer-specific supply and distribution agreements.

What commercial opportunities exist for All Day Allergy excipient innovation?

Premium self-care variants

A tiered portfolio could include:

Variant	Consumer target	Commercial rationale
Standard 10 mg tablet	Mass market	Lowest cost and broadest distribution
Lactose-free tablet	Ingredient-sensitive consumers	Differentiates without major manufacturing complexity
Dye-free tablet	Clean-label shoppers	Supports premium packaging and retailer segmentation
Sugar-free liquid	Children and adults needing liquid dosing	Expands age and administration segments
Chewable tablet	Children and portability users	Improves adherence and sensory convenience
Orally disintegrating tablet	Dysphagia and on-the-go users	Supports premium pricing
Single-dose blister	Travel and convenience users	Improves portability and dose protection
Cetirizine plus pseudoephedrine	Congestion and allergy users	Higher basket value, but greater regulatory and safety complexity

Retailer private-label programs

Cetirizine is well suited to retailer-branded products because consumers understand the active ingredient and compare products primarily on price, dose, packaging, and perceived quality.

Potential partners include:

• National pharmacy chains
• Grocery retailers
• Mass merchants
• E-commerce platforms
• Warehouse clubs
• Health-system pharmacies
• Travel and convenience retailers

The highest-value private-label opportunity is not another undifferentiated tablet. It is a retailer-exclusive format such as dye-free, lactose-free, sugar-free liquid, or individually wrapped orally disintegrating tablets.

Pediatric products

Pediatric formulations create opportunities for flavor, dose flexibility, and package design. A liquid product may support age-specific dosing, while chewables can reduce administration friction for children who resist liquid medicine.

Development priorities include:

• Accurate dose measurement
• Child-resistant packaging
• Tamper evidence
• Bitter taste suppression
• Preservative tolerance
• Clear age and dosing instructions
• Reduced sugar and alcohol content

A pediatric product must avoid overcomplicated dosing instructions that increase medication-error risk.

International expansion

Excipients may need adjustment by market because of differences in:

• Permitted colorants
• Sweetener restrictions
• Labeling requirements
• Religious and dietary requirements
• Pharmacopoeial standards
• Preservative limits
• Packaging and climate-stability conditions

A lactose-free, dye-free, sugar-free platform can reduce the number of market-specific reformulations. However, the regulatory status of cetirizine, acceptable claims, and permitted dosage forms must be evaluated jurisdiction by jurisdiction.

What manufacturing and IP barriers affect All Day Allergy?

The active ingredient is commercially available from multiple suppliers, so the main barriers are operational.

Manufacturing barriers

Key risks include:

• Cetirizine powder flow and blend uniformity
• Low-dose content uniformity in pediatric products
• Tablet capping or lamination
• Coating defects
• Moisture sensitivity in orally disintegrating tablets
• Sedimentation in liquids
• Preservative loss or incompatibility
• Flavor migration
• Packaging moisture ingress
• Supply interruptions for specialty excipients

A standard tablet can be manufactured by conventional direct compression or wet granulation, depending on powder characteristics and target performance. A rapidly disintegrating product may require specialized compression, granulation, or freeze-drying technology.

Intellectual-property barriers

A formulation patent has greater value when it protects a product characteristic that competitors cannot easily reproduce. Stronger claim targets include:

• Defined disintegration time
• Stability after accelerated storage
• Specific moisture content
• Dissolution profile
• Taste-masking performance
• Excipient ratio ranges tied to performance
• Coating architecture
• Manufacturing parameters

Weak claim targets include routine substitution of one filler for another without demonstrated technical effect.

Which companies are challenging All Day Allergy?

The principal competitors are not typically litigation challengers. They are manufacturers and retailers selling cetirizine under generic, store-brand, or competing branded labels.

Competitor group	Competitive pressure
Zyrtec	Strong consumer recognition and brand trust
Generic cetirizine manufacturers	Low-price pressure
Retailer private labels	Shelf-price and procurement pressure
Claritin	Direct oral antihistamine substitute
Allegra	Direct oral antihistamine substitute
Combination allergy products	Higher-value symptom coverage
Nasal corticosteroids	Alternative treatment category
E-commerce sellers	Rapid price comparison and assortment expansion

Biosimilar competition is irrelevant because cetirizine is a chemically synthesized small molecule, not a biologic. The relevant entry threat is generic and private-label substitution.

What generic launch risks exist for All Day Allergy?

Generic launch risk is high for the standard tablet because the active ingredient is mature, widely understood, and available in multiple equivalent dosage forms.

The main commercial scenarios are:

Scenario	Expected effect
New low-cost tablet supplier	Wholesale and retailer price compression
Retailer private-label expansion	Reduced branded shelf space
Multi-pack and club-pack launches	Lower unit economics
Liquid and chewable generic entry	Erosion of differentiated formats
E-commerce price competition	Faster consumer switching
Supply shortage at a competitor	Temporary share capture for reliable suppliers
Premium excipient variant	Opportunity to defend margin through differentiation

A supplier with strong capacity utilization, validated alternate sources, and retailer service levels can outperform a nominally lower-cost competitor during seasonal demand peaks.

What licensing deals could support All Day Allergy growth?

Licensing opportunities are most attractive in five areas:

1. Specialty excipient systems for rapid disintegration.
2. Taste-masking technology for pediatric liquids and chewables.
3. Non-gelatin capsule technology.
4. Moisture-barrier packaging for unstable dosage forms.
5. Retailer-exclusive formulation and distribution agreements.

A licensing deal should define ownership of improvements, territory, regulatory responsibility, manufacturing rights, supply guarantees, minimum purchase commitments, and exclusivity duration. For a mature OTC product, commercial terms should be tied to incremental net sales or gross margin rather than headline unit volume.

What revenue exposure does All Day Allergy have?

Revenue exposure is concentrated in seasonal allergy demand, retailer inventory cycles, and price competition. A standard tablet typically has lower revenue per unit but broader volume potential. Premium variants can raise gross margin but carry greater development, packaging, and compliance costs.

The most attractive revenue architecture is a three-tier portfolio:

• Value: standard 10 mg tablets.
• Core: dye-free, lactose-free, or larger-count packaging.
• Premium: orally disintegrating, chewable, liquid, or unit-dose formats.

Seasonality can be reduced through indoor-allergy positioning, year-round e-commerce availability, and retailer replenishment programs. Inventory planning should account for spring and early summer demand peaks, promotional calendars, and potential supply constraints in active pharmaceutical ingredient and packaging procurement.

Key Takeaways

• All Day Allergy is primarily a cetirizine hydrochloride OTC platform.
• The standard tablet has limited patent-based protection and high generic-entry exposure.
• Excipient innovation is the most practical route to premium differentiation.
• Lactose-free, dye-free, sugar-free, chewable, liquid, and orally disintegrating variants offer the clearest commercial opportunities.
• The strongest formulation patents should connect excipient selection to measurable technical performance.
• Paragraph IV litigation and biosimilar risk are generally not central to the standard OTC product.
• Manufacturing reliability, retailer access, packaging, and consumer-friendly excipients are more important than active-ingredient exclusivity.
• A tiered portfolio can protect volume through value products and improve margin through premium dosage forms.

FAQs

Is All Day Allergy the same as Zyrtec?

All Day Allergy and Zyrtec may contain the same active ingredient, cetirizine hydrochloride, at the same 10 mg strength. Inactive ingredients, dosage forms, packaging, manufacturer, labeling, and price may differ.

Can All Day Allergy be made without lactose?

Yes. Lactose can be replaced with excipients such as microcrystalline cellulose, mannitol, starch, or dibasic calcium phosphate, subject to formulation performance, stability, manufacturing, and regulatory requirements.

Is a cetirizine orally disintegrating tablet patentable?

A cetirizine orally disintegrating tablet may support patent protection if its composition or manufacturing process is novel and produces a non-obvious technical result, such as improved disintegration, stability, taste masking, or mechanical strength.

What is the best premium format for All Day Allergy?

An orally disintegrating tablet offers the clearest premium positioning because it addresses swallowing difficulty and water-free dosing. A sugar-free pediatric liquid may have greater volume potential but requires more complex stability, taste, and packaging development.

Does All Day Allergy have biosimilar competition?

No. Cetirizine is a small-molecule active ingredient. Competitive risk comes from generic cetirizine, private-label products, branded antihistamines, and alternative allergy therapies.

References

1. U.S. Food and Drug Administration. (n.d.). Cetirizine hydrochloride drug facts labeling. DailyMed. https://dailymed.nlm.nih.gov/

2. U.S. National Library of Medicine. (n.d.). All Day Allergy cetirizine hydrochloride tablet labeling. DailyMed. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (2007). FDA approves over-the-counter Zyrtec for allergy relief. https://www.fda.gov/

4. U.S. Food and Drug Administration. (2024). Over-the-counter monograph drugs. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/otc-monograph-drugs

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/、】【