List of Excipients in Branded Drug GOOD SENSE ALL DAY ALLERGY

Generic Drugs Containing GOOD SENSE ALL DAY ALLERGY

Company	Ingredient	NDC	Excipient
L Perrigo Company	cetirizine hydrochloride	0113-0981	BUTYLATED HYDROXYTOLUENE
L Perrigo Company	cetirizine hydrochloride	0113-0981	GELATIN
L Perrigo Company	cetirizine hydrochloride	0113-0981	GLYCERIN
L Perrigo Company	cetirizine hydrochloride	0113-0981	MANNITOL
L Perrigo Company	cetirizine hydrochloride	0113-0981	POLYETHYLENE GLYCOL 400

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

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

GoodSense All Day Allergy Excipient Strategy and Commercial Opportunities

Last updated: July 31, 2026

GoodSense All Day Allergy is an over-the-counter cetirizine hydrochloride product, generally marketed as a 10 mg once-daily antihistamine tablet. Its commercial position depends on low-cost manufacturing, broad tolerability, high tablet-count packaging, and compliance with the FDA’s nonprescription cetirizine framework. The core excipient opportunity is not molecule exclusivity. It is product differentiation through dosage form, swallowability, allergen positioning, packaging, and channel economics.

The leading commercial opportunities are lactose-free tablets, fast-dissolving or orally disintegrating tablets, chewable products, pediatric liquids, unit-dose packaging, and retailer-specific private-label formats. Product claims must remain within the applicable OTC monograph and labeling requirements.

What is GoodSense All Day Allergy?

GoodSense All Day Allergy is a private-label cetirizine hydrochloride product used for temporary relief of allergy symptoms, including sneezing, runny nose, itchy or watery eyes, and itching of the nose or throat. The common adult and children aged six years and older dose is 10 mg once daily, with a lower 5 mg dose used in some patients depending on age and labeling instructions (DailyMed, n.d.-a; FDA, 2024).

Active ingredient and dosage form

Attribute	Product profile
Brand	GoodSense All Day Allergy
Active ingredient	Cetirizine hydrochloride
Typical strength	10 mg per tablet
Therapeutic class	Second-generation H1 antihistamine
Primary route	Oral
Typical dosing	Once daily
Regulatory category	OTC drug
Main indications	Hay fever and upper-respiratory allergy symptoms
Primary competitive set	Zyrtec, store-brand cetirizine, loratadine, fexofenadine and related OTC antihistamines

GoodSense is generally positioned as a value alternative to national-brand cetirizine products. Its commercial model emphasizes active-ingredient equivalence and lower pricing rather than proprietary drug delivery.

What excipients are used in GoodSense All Day Allergy?

The tablet formulation has typically included conventional solid-dose excipients such as lactose, microcrystalline cellulose, crospovidone, povidone, magnesium stearate, colloidal silicon dioxide and sodium lauryl sulfate. The exact composition depends on the marketed NDC, manufacturer and package configuration. FDA labeling should control any product-specific assessment (DailyMed, n.d.-a).

Functional role of the excipients

Excipient class	Likely function	Commercial relevance
Lactose monohydrate or anhydrous lactose	Diluent and tablet bulk	Supports low-cost direct compression; creates a lactose-free differentiation opportunity
Microcrystalline cellulose	Diluent and compression aid	Improves tablet hardness and manufacturability
Crospovidone	Superdisintegrant	Supports rapid tablet breakup
Povidone	Binder	Improves granule or tablet cohesion
Magnesium stearate	Lubricant	Reduces sticking and ejection force
Colloidal silicon dioxide	Glidant and moisture-flow aid	Improves powder flow and blend uniformity
Sodium lauryl sulfate	Wetting agent or processing aid	May improve wetting but can affect mouthfeel and tolerability
Film-coating materials, where used	Appearance, protection and swallowability	Supports branded or retailer-specific presentation

The formulation is technically conventional. Its value lies in cost-effective manufacturability, acceptable stability, and reliable dissolution rather than a difficult-to-replicate excipient system.

What excipient strategy supports the GoodSense business model?

The best strategy is a platform approach using a common cetirizine tablet core across multiple retail presentations. A manufacturer can preserve the same active ingredient and core process while changing excipients, coating, tablet size, flavor, packaging or dose strength.

Low-cost standard tablet

A conventional immediate-release tablet remains the lowest-risk commercial option. A lactose-based formulation using microcrystalline cellulose, crospovidone, povidone and magnesium stearate can support high-throughput compression and low unit cost.

Key development targets include:

• Consistent tablet weight and hardness
• Rapid disintegration
• Dissolution consistent with the applicable product standard
• Low friability
• Acceptable powder flow
• Stable packaging performance under humidity exposure
• Minimal punch sticking and picking

This formulation is best suited to large-count bottles, mass retail, club stores and e-commerce.

Lactose-free formulation

A lactose-free version could address consumers who avoid lactose or prefer a simplified excipient profile. Mannitol, anhydrous dibasic calcium phosphate, additional microcrystalline cellulose or selected starch-based diluents could replace lactose.

The principal tradeoffs are:

• Mannitol can improve mouthfeel but may increase formulation cost.
• Dibasic calcium phosphate can improve compactibility but may alter tablet density and dissolution.
• Starch-based systems can require tighter control of moisture and compression conditions.
• Removing lactose may require rebalancing binder and disintegrant levels.

A lactose-free claim must be supported by formulation controls and appropriate labeling. It should not imply suitability for every milk-protein allergy unless supported by the complete manufacturing and excipient profile.

Dye-free and simplified excipient positioning

A dye-free tablet can appeal to consumers seeking fewer additives. The commercial benefit is strongest when the retailer uses a clear "dye-free" or "no artificial colors" positioning supported by the ingredient declaration.

Simplification can also reduce:

• Colorant supply complexity
• Labeling review burden
• Batch-to-batch appearance variability
• Risk of consumer complaints related to coloring agents

A plain white tablet, however, must remain visually distinct enough to support product identification and prevent medication errors.

Fast-dissolving and orally disintegrating tablets

An orally disintegrating tablet, or ODT, is the most credible excipient-led extension. A cetirizine ODT can target consumers who have difficulty swallowing conventional tablets or who want administration without water.

Typical ODT excipient systems may use:

• Mannitol for mouthfeel and bulk
• Crospovidone, croscarmellose sodium or sodium starch glycolate for disintegration
• Low-substituted hydroxypropyl cellulose for structure
• Aspartame, sucralose or other sweeteners
• Flavor systems such as mint, fruit or neutral masking flavors
• Silica and lubricants optimized for direct compression

Commercial barriers include taste masking, tablet friability, moisture sensitivity, packaging cost and dose uniformity. ODT development also creates a more defensible product specification than a standard generic-style tablet, although the underlying cetirizine molecule remains unprotected.

What formulations are protected by patents?

GoodSense All Day Allergy does not derive its commercial position from an active-ingredient patent estate. Cetirizine has been marketed for decades, and the relevant U.S. drug exclusivity period has expired. The principal opportunity is formulation and presentation differentiation rather than molecule exclusivity.

Patent categories relevant to a cetirizine product

Patent category	Relevance to GoodSense
Cetirizine composition-of-matter patents	Expired and no longer a practical barrier to standard OTC entry
Immediate-release tablet patents	Generally low strategic value unless a specific formulation is claimed
ODT and taste-masked formulations	Potentially relevant to differentiated products
Liquid and pediatric formulations	May contain formulation or process claims, depending on the product
Packaging and delivery systems	Can protect commercial presentation but rarely blocks standard tablets
Manufacturing-process patents	May affect cost or scale if a proprietary process is used
Method-of-use patents	Limited value for routine OTC allergy indications

A freedom-to-operate review should examine live U.S. and foreign claims covering taste masking, ODT manufacture, liquid suspension stability, flavor systems, packaging and specific excipient ratios. A generic tablet strategy normally faces less formulation-patent risk than an ODT or pediatric liquid strategy.

When does cetirizine lose exclusivity?

Cetirizine lost meaningful U.S. small-molecule exclusivity before GoodSense entered the market. The FDA approved Zyrtec as a prescription product in 1995 and approved the switch to nonprescription status in 2007. The OTC market now includes national brands, store brands and generic-equivalent products (FDA, 2007).

Exclusivity timeline

Milestone	Date	Commercial significance
Prescription cetirizine approval	1995	Established the original U.S. product
OTC switch approval for Zyrtec	2007	Expanded consumer access and retail competition
Store-brand and generic-style entry	Following OTC expansion	Shifted competition toward price, packaging and distribution
Current market	Ongoing	No meaningful molecule-level exclusivity for standard cetirizine tablets

What is the Orange Book status of GoodSense All Day Allergy?

GoodSense All Day Allergy is an OTC product and is not generally evaluated as a conventional prescription NDA product with an Orange Book patent-listing strategy. The Orange Book is principally relevant to approved prescription and certain other FDA-approved drug applications, including listed patents and therapeutic-equivalence information (FDA, n.d.-a).

The commercial consequences are material:

• A standard GoodSense OTC tablet does not depend on a branded NDA patent estate.
• Paragraph IV litigation is not the normal entry mechanism for a private-label OTC monograph product.
• Competitive risk is driven by FDA compliance, manufacturing capacity, retailer contracts, product quality and price.
• A company launching a new cetirizine dosage form may need an abbreviated new drug application, an OTC monograph route where available, or another FDA-recognized pathway depending on the formulation and claims.

Are Paragraph IV challenges relevant to GoodSense?

Paragraph IV challenges are generally not the central legal pathway for standard GoodSense All Day Allergy products. Paragraph IV certifications arise when an ANDA applicant seeks approval for a drug referencing an NDA and certifies that listed patents are invalid, unenforceable or not infringed.

For cetirizine OTC products, the principal legal analysis is different. It focuses on:

• Whether the product complies with the applicable OTC monograph
• Whether the formulation or claims require an approved application
• Whether the product copies protected formulation or packaging claims
• Whether trademarks, trade dress or retailer branding create separate risks
• Whether manufacturing and labeling comply with the Federal Food, Drug, and Cosmetic Act

A differentiated ODT, liquid or combination product can create a more complex patent and regulatory profile than a basic 10 mg tablet.

What FDA regulatory status applies to cetirizine products?

Cetirizine is an established OTC antihistamine active ingredient. The FDA’s OTC Monograph Drug User Fee Program identifies the monograph framework governing nonprescription drug products, while FDA labeling and monograph materials define permitted active ingredients, indications, doses and warnings (FDA, n.d.-b).

A compliant product strategy must address:

• Active ingredient identity and strength
• Permitted allergy indications
• Age-specific dosing
• Warnings regarding drowsiness and alcohol or sedative use
• Label format and Drug Facts requirements
• cGMP compliance
• Stability and container-closure performance
• Child-resistant packaging requirements where applicable
• Manufacturer and distributor responsibilities

A novel delivery system may fall outside the simplest monograph pathway. Regulatory classification should be confirmed before development begins because a formulation change can affect the required application route.

How many patents cover GoodSense All Day Allergy?

No meaningful patent count can be assigned to the standard GoodSense product solely from its brand name. The relevant analysis is claim-specific and product-specific. A conventional cetirizine tablet is exposed to broad competition because the active ingredient and basic dosage form are established.

The more relevant patent questions are:

1. Does the proposed product use a patented ODT architecture?
2. Does the taste-masking system fall within active claims?
3. Does the liquid formulation use a protected stabilizer or suspension system?
4. Does the package include a patented dispensing mechanism?
5. Does the manufacturing process rely on a live process patent?
6. Are foreign patents still active in the target markets?

A product based on standard excipients and conventional direct compression is more likely to have a low blocking-patent risk than a specialized delivery system.

Which commercial opportunities exist for GoodSense excipient innovation?

Pediatric liquid and chewable products

Liquid cetirizine can address younger children and consumers who cannot swallow tablets. The main formulation issues are taste, sedimentation, preservative selection, viscosity, dosing-device accuracy and microbial control.

Chewable tablets offer a lower-cost alternative to liquids. Mannitol, sorbitol, xylitol, sweeteners, flavors and taste-masking agents can improve acceptability. Sugar-free positioning may appeal to parents, but polyol content can affect gastrointestinal tolerability.

High-count and unit-dose packaging

GoodSense already fits a high-volume value model. Packaging innovation can expand distribution:

• 365-count bottles for annual-use economics
• Smaller travel packs
• Blister cards for adherence and portability
• Unit-dose packs for institutions and workplace first-aid programs
• Child-resistant bottles with senior-friendly closure options
• Moisture-barrier packaging for ODT products

Packaging economics are especially important because the tablet itself is inexpensive and retail margin depends heavily on pack size, shelf placement and channel fees.

Combination products

Cetirizine may be combined with other active ingredients for congestion or related symptoms, but combination products carry greater regulatory and safety complexity. Pseudoephedrine combinations involve controlled retail processes and additional labeling requirements. A manufacturer should not assume that a combination can use the same monograph route as a single-ingredient cetirizine product.

How does GoodSense compare with competing allergy products?

Product category	Main active ingredient	Excipient opportunity	Commercial position
GoodSense cetirizine tablet	Cetirizine	Lactose-free, dye-free, ODT and high-count packs	Value and private label
Loratadine store brand	Loratadine	Small tablets, ODT, chewables	Low-sedation positioning
Fexofenadine store brand	Fexofenadine	Large-tablet swallowability and cost reduction	Premium non-drowsy positioning
Branded Zyrtec	Cetirizine	Brand packaging, broad line extensions	National-brand recognition
Cetirizine liquid	Cetirizine	Taste masking, viscosity and dosing accuracy	Pediatric and swallowability segment
Cetirizine chewable	Cetirizine	Flavor, sweetener and texture	Family and pediatric use

Cetirizine generally has strong consumer recognition, but some consumers perceive it as more sedating than loratadine or fexofenadine. Excipient innovation cannot eliminate pharmacologic sedation. Product claims must not overstate a formulation’s effect on drowsiness.

What generic launch risks exist for a new cetirizine product?

The principal risks are commercial and regulatory rather than molecule-patent risks.

Key risks

• Price compression from multiple store brands
• Retailer preference for established suppliers
• Manufacturing concentration and supply interruptions
• Taste and mouthfeel failure in ODT or chewable products
• Dose-measuring errors in pediatric liquids
• Stability problems caused by moisture or flavor systems
• Labeling noncompliance
• Trademark or trade-dress disputes
• Consumer confusion among similar private-label products
• Low return on investment for a differentiated formulation without retail placement

A standard tablet can launch quickly but has limited differentiation. A novel dosage form can command a higher margin but requires more development, packaging and regulatory work.

What licensing deals could support a GoodSense extension?

Licensing is most relevant to technology, not cetirizine itself. Potential targets include:

• ODT manufacturing platforms
• Taste-masking technologies
• Pediatric flavor systems
• Unit-dose dispensing packages
• Moisture-barrier blister systems
• Low-cost continuous manufacturing processes
• Retailer or pharmacy private-label agreements

A licensing transaction should distinguish between patent rights, know-how, regulatory support, manufacturing rights and territory. A technology license with only expired or narrow patent claims may provide limited competitive protection. Know-how can still have value when it reduces scale-up time or improves product yield.

What geographic markets are attractive?

The United States is attractive because cetirizine is a mature OTC category with established consumer demand and extensive retail distribution. The opportunity is strongest in private-label, e-commerce and club-store channels.

Other markets require separate review of:

• OTC versus prescription classification
• Approved cetirizine strengths and dosage forms
• Local excipient restrictions
• Pediatric labeling
• Flavor and sweetener requirements
• Packaging and serialization rules
• Patent status by jurisdiction
• Import and manufacturing requirements

A formulation that is commercially efficient in the U.S. may require different excipients or packaging in Europe, Canada, Australia or emerging markets. Geographic expansion should use a jurisdiction-by-jurisdiction regulatory and freedom-to-operate matrix.

How strong is the patent estate for GoodSense All Day Allergy?

The patent estate is weak for a standard cetirizine tablet because the active ingredient is long established and the formulation uses conventional excipients. The defensible value is more likely to reside in:

• Retailer contracts
• Supplier qualification
• Manufacturing cost
• Quality history
• Packaging configuration
• Trademark ownership
• Consumer distribution
• Specialized formulation know-how

A stronger product-level position could be developed around an ODT, pediatric suspension, taste-masked chewable or proprietary dispensing package. Even then, patent strength depends on claim breadth, remaining term, validity and design-around options.

Key Takeaways

• GoodSense All Day Allergy is a value-positioned OTC cetirizine hydrochloride product, typically supplied as a 10 mg tablet.
• The standard tablet has low molecule-level patent risk and limited formulation exclusivity.
• Conventional excipients support low-cost, high-volume production but provide little differentiation.
• The strongest excipient-led opportunities are lactose-free tablets, ODTs, chewables, pediatric liquids and improved packaging.
• ODT and liquid products create greater commercial upside but also introduce taste, stability, packaging and regulatory risks.
• Paragraph IV litigation and Orange Book patent strategy are generally less relevant than OTC monograph compliance and product-specific freedom-to-operate analysis.
• Commercial advantage is likely to come from retailer access, supply reliability, pack architecture and cost rather than active-ingredient patents.

FAQs

Is GoodSense All Day Allergy the same active ingredient as Zyrtec?

Yes. GoodSense All Day Allergy products generally use cetirizine hydrochloride as the active ingredient. Inactive ingredients, tablet design, packaging and manufacturing source may differ.

Can a lactose-free cetirizine product compete with GoodSense?

Yes. A lactose-free product could target consumers who avoid lactose or prefer a simplified excipient profile. The product would need validated formulation controls and accurate labeling.

Is cetirizine ODT development commercially attractive?

It can be attractive where swallowability and convenience support a premium. The primary development challenges are taste masking, friability, moisture protection and packaging cost.

Does a cetirizine product need a Paragraph IV certification?

Not necessarily. The pathway depends on the product’s regulatory basis and reference product. A conventional OTC monograph product generally does not follow the same patent-certification model as an ANDA referencing a patented prescription NDA.

Which excipients are most important in a cetirizine pediatric liquid?

Taste-masking agents, sweeteners, flavors, viscosity modifiers, preservatives and suspension stabilizers are central. The formulation must also support accurate dosing and microbial control.

References

1. DailyMed. (n.d.-a). Cetirizine hydrochloride tablet: Drug labeling information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

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

3. U.S. Food and Drug Administration. (2024). Drug facts label requirements for nonprescription human drug products. https://www.fda.gov/

4. U.S. Food and Drug Administration. (n.d.-a). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

5. U.S. Food and Drug Administration. (n.d.-b). Over-the-counter monograph drug user fee program. https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program OTC Monograph Drug User Fee Program.