List of Excipients in Branded Drug ALL DAY ALLERGY-D

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Generic Drugs Containing ALL DAY ALLERGY-D

Company	Ingredient	NDC	Excipient
L Perrigo Company	cetirizine hcl, pseudoephedrine hcl	0113-2176	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	cetirizine hcl, pseudoephedrine hcl	0113-2176	FERRIC OXIDE YELLOW
L Perrigo Company	cetirizine hcl, pseudoephedrine hcl	0113-2176	HYPROMELLOSES
L Perrigo Company	cetirizine hcl, pseudoephedrine hcl	0113-2176	LACTOSE MONOHYDRATE
L Perrigo Company	cetirizine hcl, pseudoephedrine hcl	0113-2176	MAGNESIUM STEARATE

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

# Of NDCs	Excipient
1	AMMONIA
1	BUTYL ALCOHOL
2	CELLULOSE, MICROCRYSTALLINE
1	FERRIC OXIDE YELLOW
1	FERROSOFERRIC OXIDE

All Day Allergy-D Excipient Strategy and Commercial Opportunities

Last updated: September 16, 2026

All Day Allergy-D is an extended-release combination of cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg. Its commercial value depends less on active-ingredient exclusivity than on reliable 12-hour release, tablet manufacturability, consumer convenience, and compliance with pseudoephedrine sales controls. The strongest opportunities are private-label differentiation, improved extended-release performance, packaging, and supply-chain execution rather than new-molecule patent protection.

What is All Day Allergy-D and how is it regulated?

All Day Allergy-D combines an antihistamine with a nasal decongestant:

Attribute	Product profile
Active ingredients	Cetirizine hydrochloride 5 mg; pseudoephedrine hydrochloride 120 mg
Dosage form	Extended-release oral tablet
Intended duration	12 hours
Therapeutic uses	Temporary relief of nasal congestion, sinus pressure, sneezing, runny nose, and itchy or watery eyes associated with allergies or the common cold
Regulatory category	OTC combination drug
Reference-product positioning	Comparable to Zyrtec-D 12 Hour and other cetirizine/pseudoephedrine products
Principal commercial constraint	Pseudoephedrine sales controls and behind-the-counter distribution

The product is generally sold as a private-label or store-brand equivalent of cetirizine/pseudoephedrine extended-release tablets. Exact inactive ingredients can vary by manufacturer, package size, and production site. The applicable product label and Drug Facts panel control the marketed formulation.

Cetirizine is an H1 antihistamine. Pseudoephedrine is a sympathomimetic decongestant. The combination addresses two different symptom pathways, but it also creates formulation and labeling constraints that do not apply to cetirizine-only allergy products.

What excipient strategy is required for All Day Allergy-D?

The excipient system must support two objectives: immediate release of cetirizine and controlled release of pseudoephedrine over approximately 12 hours. The formulation also must produce a robust tablet that survives coating, packaging, distribution, and consumer handling.

Functional excipient architecture

A typical formulation strategy may include the following functional classes:

Formulation function	Relevant excipient classes	Commercial purpose
Dilution and compressibility	Microcrystalline cellulose, lactose, dibasic calcium phosphate, or comparable fillers	Establishes tablet weight and supports direct compression or granulation
Matrix formation	Hydrophilic polymers such as hypromellose	Controls pseudoephedrine diffusion and hydration
Binder	Povidone, copovidone, pregelatinized starch, or equivalent	Improves granule and tablet strength
Disintegrant	Crospovidone, croscarmellose sodium, or sodium starch glycolate	Supports cetirizine release and tablet breakup where required
Lubricant	Magnesium stearate, stearic acid, or sodium stearyl fumarate	Reduces sticking and ejection force
Glidant	Colloidal silicon dioxide or equivalent	Improves powder flow
Film coating	Hypromellose, polyvinyl alcohol, plasticizer, pigment, and opacifier	Protects the tablet and supports identification
Moisture-control system	High-barrier blister or bottle, desiccant where justified	Protects release performance and tablet integrity

The key technical issue is avoiding excipient interactions that cause dose dumping or release drift. A high-viscosity hydrophilic polymer can control pseudoephedrine release, but excessive polymer loading may slow release beyond the intended profile. Excessive tablet porosity can accelerate hydration and release. Compression force, particle size, polymer grade, and coating permeability all affect the dissolution profile.

How should cetirizine and pseudoephedrine release be balanced?

The formulation should normally deliver cetirizine without undermining the extended-release behavior of pseudoephedrine. A matrix tablet can achieve this through differential solubility, particle distribution, polymer concentration, or a multilayer design.

A practical development sequence is:

1. Establish pseudoephedrine release targets at multiple dissolution pH values.
2. Confirm that cetirizine release does not become excessively delayed by the matrix.
3. Test robustness across compression force, tablet hardness, friability, and storage humidity.
4. Evaluate alcohol sensitivity and agitation effects.
5. Compare pilot-scale and commercial-scale dissolution profiles.
6. Link critical material attributes to assay, content uniformity, and dissolution.

A multilayer tablet or coated-particle design may provide greater release control, but it increases manufacturing cost and process complexity. For a value-oriented private-label product, a conventional hydrophilic matrix is generally more commercially attractive if it meets dissolution and stability requirements.

Which excipients create the strongest commercial opportunities?

Direct-compression platforms

Direct compression can reduce processing steps and improve manufacturing economics. Microcrystalline cellulose, suitable grades of lactose or phosphate filler, a low-level binder, and a controlled-release polymer may support a compact process.

The principal risks are poor flow, segregation between the two active ingredients, content-uniformity failures, and sensitivity to lubricant concentration. Cetirizine and pseudoephedrine have different dose levels, densities, and particle characteristics. A formulation that appears acceptable at laboratory scale may segregate during hopper transfer or high-speed compression.

Polymer optimization

Polymer selection offers the most defensible technical differentiation. Opportunities include:

• Lower tablet weight at equivalent release performance.
• Reduced sensitivity to compression-force variation.
• More consistent release across fed and fasted conditions.
• Lower sensitivity to alcohol exposure.
• Improved manufacturability at high tablet speeds.
• Reduced reliance on a single high-cost specialty polymer.

A polymer platform that provides a reproducible 12-hour dissolution profile may support process patents, formulation know-how, or regulatory differentiation. It is less likely to support a strong composition-of-matter patent because both active ingredients and the general extended-release concept are established.

Taste and swallowability

Taste masking is less important than in liquid pediatric products because All Day Allergy-D is a tablet intended to be swallowed whole. Tablet dimensions, coating smoothness, debossing, and edge geometry are more relevant. Consumers may reject a large or rough tablet even when the active ingredients and price are competitive.

A thinner caplet or lower-weight matrix tablet could provide a retail advantage. Any reduction in size must preserve dose uniformity, mechanical strength, and release performance.

Packaging and moisture protection

Packaging is a material commercial variable. Extended-release tablets may be sensitive to moisture uptake, coating defects, or changes in matrix hydration. Options include:

• High-density polyethylene bottles with induction seals.
• Blister packaging with high-barrier foil.
• Unit-dose or calendar packaging.
• Tamper-evident child-resistant systems.
• Smaller count sizes for seasonal or trial purchases.

Blisters can improve portability and dose tracking but may raise packaging cost. Bottles generally support lower unit costs and larger-count formats. A retailer may prefer bottles for core allergy-season volume and blister packs for travel, club, or convenience channels.

What patents protect All Day Allergy-D?

The active-ingredient combination has limited current patent value. Cetirizine and pseudoephedrine are long-established ingredients, and the principal commercial products have been exposed to generic and private-label competition for years.

Patent and exclusivity assessment

Rights category	Assessment
Active-ingredient patents	Expired or commercially irrelevant for this product
Basic combination patents	Weak current barrier because the combination is established
Extended-release formulation patents	Potentially relevant only for specific release architectures
Manufacturing patents	Possible protection for granulation, coating, matrix formation, or scale-up controls
Method-of-use patents	Limited value for conventional allergy and congestion indications
Packaging patents	Possible, but generally narrow and easy to design around
Regulatory exclusivity	No meaningful current exclusivity expected for a mature OTC combination
Biosimilar exposure	None; this is a small-molecule OTC product, not a biologic

A new entrant would normally focus on freedom to operate around specific formulation and manufacturing claims rather than seeking broad exclusivity over cetirizine plus pseudoephedrine. Patent diligence should cover U.S. and foreign filings relating to extended-release cetirizine/pseudoephedrine tablets, polymer matrices, multiparticulates, and alcohol-resistant release systems.

What is the Orange Book status of All Day Allergy-D?

All Day Allergy-D is not commercially protected by a conventional new-drug exclusivity position. The product category is dominated by OTC labeling, monograph compliance, legacy approved products, and private-label supply arrangements.

Orange Book analysis should distinguish between:

• A specific FDA-approved NDA product and its listed patents.
• A private-label OTC product marketed under applicable OTC requirements.
• A generic product approved through an ANDA referencing an approved product.
• A contract-manufactured store brand whose commercial identity differs from the underlying manufacturer.

The presence of a legacy Orange Book listing for a reference product would not automatically create a meaningful barrier against a formulation that uses a different release design and does not infringe an enforceable claim. Paragraph IV risk is therefore product-specific. A potential entrant must review current Orange Book listings, FDA approval pathways, active claims, and any litigation tied to the selected formulation.

When does All Day Allergy-D lose exclusivity?

All Day Allergy-D has no significant remaining exclusivity timeline comparable to a newly approved prescription product. Cetirizine, pseudoephedrine, and the combination category are mature. Generic and private-label competition is already established.

The commercial timetable is instead determined by:

• FDA or applicable OTC pathway acceptance.
• Stability and dissolution completion.
• Manufacturing transfer.
• Retailer onboarding.
• Pseudoephedrine registration and sales controls.
• Seasonal inventory planning.
• Contract manufacturing capacity.

A launch aimed at the spring allergy season may require manufacturing and packaging completion months in advance. Demand can shift rapidly based on weather, pollen levels, respiratory-virus activity, and retail promotions.

What generic entry risks exist?

Generic entry risk is high because the product uses familiar active ingredients and a mature dosage form. The main barriers are operational rather than legal.

Technical risks

A competitor may encounter:

• Pseudoephedrine content-uniformity problems.
• Dissolution failures after scale-up.
• Tablet sticking during compression.
• Polymer variability between suppliers.
• Inconsistent release after humidity exposure.
• Packaging-related stability failures.
• Failure to match required labeling and warnings.
• Supply interruptions caused by controlled-precursor requirements.

The most credible differentiation is a formulation that reduces these risks at commercial scale.

Regulatory and distribution risks

Pseudoephedrine is subject to federal purchase restrictions, logbook requirements, identification checks, transaction limits, and retail controls under the Combat Methamphetamine Epidemic Act. State requirements can add operational complexity. Retailers also manage theft, inventory reconciliation, and shelf placement.

These controls can reduce the attractiveness of small-volume distributors and favor manufacturers with established pharmacy, grocery, mass-retail, and e-commerce compliance systems.

Which companies are challenging the market?

The relevant competitive set includes:

• Branded cetirizine/pseudoephedrine products, including Zyrtec-D.
• Store brands sold through major pharmacies, supermarkets, mass merchants, and warehouse clubs.
• Generic manufacturers with OTC or approved combination products.
• Contract manufacturers specializing in controlled-release tablets.
• Cetirizine-only products, which compete for allergy demand without pseudoephedrine restrictions.
• Loratadine/pseudoephedrine and fexofenadine/pseudoephedrine products, which compete within the broader decongestant-antihistamine segment.

All Day Allergy-D competes on price, availability, brand trust, tablet count, and convenience. It does not compete primarily through novel pharmacology.

How does All Day Allergy-D compare with cetirizine-only products?

Factor	All Day Allergy-D	Cetirizine-only tablet
Symptom coverage	Allergy symptoms plus congestion	Allergy symptoms
Formulation	Extended-release combination	Usually immediate-release
Retail controls	Pseudoephedrine restrictions apply	No comparable pseudoephedrine controls
Manufacturing complexity	Higher	Lower
Consumer segment	Consumers with congestion and allergies	Consumers needing antihistamine relief
Patent opportunity	Narrow formulation and process claims	Limited for mature active
Supply-chain risk	Higher	Lower
Price competition	High	Very high

A manufacturer may generate more predictable volume with cetirizine-only products, while All Day Allergy-D can command a convenience premium when nasal congestion is a primary symptom.

What licensing and manufacturing opportunities exist?

The most realistic licensing opportunity is a formulation and supply agreement rather than a license to a foundational patent. Potential deal structures include:

• Private-label supply for national retailers.
• Exclusive regional distribution.
• Contract manufacturing with technology transfer.
• Co-development of a lower-weight or improved-release tablet.
• Packaging and serialization services.
• Seasonal capacity reservations.
• Dual-source manufacturing arrangements.

A buyer should evaluate not only the tablet formula but also ownership of batch records, process parameters, dissolution methods, stability data, regulatory files, and change-control rights. The commercial value of a private-label product can be impaired if the retailer cannot switch sites or qualify a second source quickly.

What is the revenue exposure and commercial upside?

Product-level revenue for All Day Allergy-D is generally not separately disclosed. The commercial opportunity should therefore be modeled from units, retail price, retailer margin, manufacturer transfer price, and seasonal sell-through rather than public brand revenue.

The main value drivers are:

1. Retail distribution breadth.
2. Supply reliability during allergy season.
3. Tablet cost per dose.
4. Pseudoephedrine compliance capability.
5. Shelf-life and inventory flexibility.
6. Retailer willingness to substitute the product for branded Zyrtec-D.
7. Packaging cost and count-size strategy.

A 12-count or 24-count package can support convenience and trial purchases. Larger counts may lower per-dose cost but increase inventory exposure and expiration risk. A dual-source strategy can reduce retailer disruption but may require additional qualification expense.

How strong is the patent estate for All Day Allergy-D?

The patent estate is weak for broad exclusivity and potentially moderate for narrow formulation or manufacturing protection. The strongest protectable elements would be:

• A defined polymer matrix with narrow release limits.
• A multilayer or multiparticulate architecture.
• A process that controls segregation and content uniformity.
• An alcohol-resistant release profile.
• A low-weight tablet with a specific dissolution profile.
• A packaging configuration that preserves stability under defined conditions.

The principal business moat is likely to be regulatory execution, manufacturing know-how, retailer relationships, and cost control. Patent claims can supplement that position but are unlikely to prevent broad substitution by other cetirizine/pseudoephedrine manufacturers.

Key Takeaways

• All Day Allergy-D is a cetirizine 5 mg and pseudoephedrine 120 mg extended-release OTC tablet.
• Its commercial differentiation depends on controlled release, tablet quality, packaging, price, and distribution.
• The active ingredients and general combination are mature and offer little broad patent protection.
• Excipient strategy should prioritize pseudoephedrine release control, content uniformity, compression robustness, and moisture stability.
• Hydrophilic polymer matrices are likely to provide the best balance between performance and manufacturing cost.
• Pseudoephedrine controls create operational barriers but also favor suppliers with established retail compliance systems.
• The strongest commercial opportunities are private-label supply, improved tablet architecture, packaging, and dual-source manufacturing.
• Biosimilar risk is irrelevant because the product is a small-molecule OTC combination.
• Paragraph IV and Orange Book issues must be assessed against the specific regulatory pathway and formulation, not the product name alone.
• Revenue exposure is likely seasonal and retailer-driven, with no generally disclosed product-level sales figure.

FAQs

Can All Day Allergy-D be reformulated as an immediate-release tablet?

Not without changing the intended dosage form and regulatory basis. The 120 mg pseudoephedrine component is designed for extended release, so an immediate-release version would require separate regulatory and clinical-performance analysis.

Are excipients in All Day Allergy-D patentable?

Individual common excipients generally provide limited patent value. A specific combination, polymer ratio, release profile, processing method, or stability result may support narrower formulation or process claims.

Is a liquid version of All Day Allergy-D commercially attractive?

It could address consumers who cannot swallow tablets, but pseudoephedrine stability, taste, dosing accuracy, packaging, and extended-release control would make the product materially more complex than the tablet.

Can All Day Allergy-D be sold freely through e-commerce?

Pseudoephedrine transaction controls still apply. Online sales may require age verification, purchaser identification, quantity limits, recordkeeping, and state-specific compliance.

What is the best near-term product improvement?

A lower-weight tablet with consistent 12-hour pseudoephedrine release, strong humidity stability, and a lower-cost high-barrier package offers the clearest combination of consumer and manufacturing value.

References

1. Code of Federal Regulations. (2024). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use.
2. DailyMed. (n.d.). Cetirizine hydrochloride and pseudoephedrine hydrochloride extended-release tablet labeling. U.S. National Library of Medicine.
3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations.
4. U.S. Drug Enforcement Administration. (n.d.). Retail sales of scheduled listed chemical products and pseudoephedrine requirements.
5. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Title VII of the USA PATRIOT Improvement and Reauthorization Act.