List of Excipients in Branded Drug GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY D

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Generic Drugs Containing GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY D

Company	Ingredient	NDC	Excipient
Amerisource Bergen	cetirizine hcl, pseudoephedrine hcl	24385-175	CELLULOSE, MICROCRYSTALLINE
Amerisource Bergen	cetirizine hcl, pseudoephedrine hcl	24385-175	FERRIC OXIDE YELLOW
Amerisource Bergen	cetirizine hcl, pseudoephedrine hcl	24385-175	HYPROMELLOSE

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

# Of NDCs	Excipient
2	CELLULOSE, MICROCRYSTALLINE
1	FERRIC OXIDE YELLOW
2	HYPROMELLOSE

Excipient Strategy and Commercial Opportunities for Good Neighbor Pharmacy All Day Allergy-D

Last updated: September 24, 2026

Good Neighbor Pharmacy All Day Allergy-D is an OTC extended-release combination product containing cetirizine hydrochloride, an antihistamine, and pseudoephedrine hydrochloride, an oral nasal decongestant. The typical 12-hour strength is cetirizine hydrochloride 5 mg plus pseudoephedrine hydrochloride 120 mg per extended-release tablet. Its commercial position depends less on active-ingredient exclusivity than on reliable extended-release performance, low-cost manufacturing, compliant packaging, and pharmacy-channel availability.

The strongest excipient opportunities are controlled drug release, tablet robustness, moisture protection, coating performance, and manufacturability. The principal commercial constraints are pseudoephedrine purchase controls, behind-the-counter distribution, retail substitution, and competition from branded Zyrtec-D and other private-label products.

What is Good Neighbor Pharmacy All Day Allergy-D?

Good Neighbor Pharmacy All Day Allergy-D is a store-brand OTC drug for temporary relief of allergy and cold-related symptoms, including nasal congestion, sneezing, runny nose, itchy or watery eyes, and sinus pressure. The product combines:

Component	Typical amount per 12-hour tablet	Function
Cetirizine hydrochloride	5 mg	H1 antihistamine
Pseudoephedrine hydrochloride	120 mg	Nasal decongestant
Dosage form	Extended-release tablet	Sustained delivery over approximately 12 hours

The product is positioned as a private-label alternative to Zyrtec-D 12 Hour. The active ingredients are well established, and the product does not depend on a new chemical entity, biologic platform, or novel mechanism of action.

The formulation challenge is the combination of a low-dose antihistamine with a relatively high-dose sympathomimetic in a compact oral extended-release tablet. The tablet must maintain release control for pseudoephedrine while delivering cetirizine consistently and surviving packaging, shipping, retail handling, and patient use.

What excipients are strategically important in All Day Allergy-D?

The most important excipient categories are release-control polymers, tablet binders, disintegrants, lubricants, glidants, fillers, coating materials, and moisture-control components.

Extended-release matrix polymers

Pseudoephedrine hydrochloride is water soluble. Without release control, it can dissolve rapidly and produce an unsuitable exposure profile. The formulation therefore requires a release-controlling system, commonly based on hydrophilic polymers such as hypromellose or related matrix-forming materials.

The commercial objectives are:

• Maintain approximately 12-hour release.
• Prevent dose dumping after tablet damage or variable gastrointestinal conditions.
• Limit manufacturing variability.
• Preserve release performance after aging.
• Avoid excessive tablet size or swallowing difficulty.

Polymer viscosity grade is a major formulation variable. Higher-viscosity hypromellose can slow drug diffusion but may increase granulation torque, tablet weight, and processing difficulty. Lower-viscosity grades can improve manufacturability but may require higher polymer loading or a secondary coating system.

Fillers and compression aids

Microcrystalline cellulose, lactose, dibasic calcium phosphate, mannitol, and related fillers can support tablet weight, compressibility, and content uniformity. The selection depends on the manufacturing process.

Microcrystalline cellulose is attractive for direct compression because it improves compactibility and tablet strength. Dibasic calcium phosphate can reduce hygroscopicity but may create density and dissolution differences. Lactose can improve processing economics but may present compatibility or moisture-management considerations. The best commercial excipient system is the one that supports consistent hardness without slowing scale-up.

Binders and granulation aids

Povidone, copovidone, pregelatinized starch, and hypromellose can improve granule strength and reduce segregation between the low-dose cetirizine component and the higher-load pseudoephedrine component.

Content uniformity is particularly important because cetirizine represents a small fraction of the total active load. A formulation with poor segregation control can produce variability even when the average batch assay is acceptable. Wet granulation, dry granulation, or ordered mixing can be evaluated depending on the excipient compatibility profile and release-control design.

Disintegrants

A controlled-release product still requires controlled tablet hydration and structural integrity. Sodium starch glycolate, croscarmellose sodium, and crospovidone can improve breakup of non-matrix portions of the tablet.

Excessive disintegrant loading can undermine extended release by creating channels through the matrix. The commercial formulation target is not the fastest disintegration. It is predictable hydration and erosion that remains within the approved dissolution profile.

Lubricants and glidants

Magnesium stearate is widely used to reduce friction during tablet ejection. Its concentration and blending time require control because over-lubrication can reduce tablet hardness, slow wetting, and alter dissolution.

Colloidal silicon dioxide can improve powder flow and reduce weight variation. Talc may support flow and processing but can affect coating and surface properties. These excipients have limited differentiation value by themselves, but they can determine whether the product runs efficiently at commercial scale.

Film-coating materials

A film coat can improve appearance, swallowing, color identification, moisture protection, and resistance to abrasion. Hypromellose-based coatings with polyethylene glycol or other plasticizers are common options.

For a private-label product, coating has commercial value because it creates a recognizable store-brand presentation without materially increasing manufacturing complexity. A robust coating can also reduce tablet chipping and powder generation in bottles or blister packs.

What formulation patents protect extended-release cetirizine and pseudoephedrine products?

The main protection for this product category is regulatory compliance and formulation know-how rather than a new active-ingredient patent estate.

Branded cetirizine-pseudoephedrine products historically relied on drug-product approvals and formulation development. Private-label versions generally compete through OTC regulatory pathways, approved labeling, manufacturing capability, and contract-manufacturing arrangements.

Potentially protectable technical features include:

• A specific hydrophilic matrix composition.
• A multilayer tablet separating cetirizine and pseudoephedrine.
• A coated-pellet or multiparticulate delivery system.
• A dissolution profile across acidic and neutral media.
• A manufacturing sequence that limits active segregation.
• A moisture-resistant package or tablet coating.
• A process for controlling pseudoephedrine release without compromising cetirizine dissolution.

A broad patent claim covering standard use of hypromellose, microcrystalline cellulose, or magnesium stearate would face substantial prior-art risk. Commercial value is more likely to arise from a narrow, reproducible formulation with demonstrated dissolution and stability advantages.

When does All Day Allergy-D lose exclusivity?

Good Neighbor Pharmacy All Day Allergy-D does not have the conventional exclusivity profile of a newly approved prescription drug. Cetirizine and pseudoephedrine are longstanding active ingredients, and competing OTC products are widely available.

The key exclusivity categories are:

Exclusivity type	Relevance to All Day Allergy-D
New chemical entity exclusivity	Not applicable
Prescription drug exclusivity	Not applicable to the typical store-brand OTC product
Orphan exclusivity	Not applicable
Pediatric exclusivity	Not generally relevant
OTC monograph market protection	No broad product monopoly
Formulation patent protection	Possible, but dependent on specific claims and ownership
Trademark or private-label protection	Brand and trade-dress protection may apply
Supply or channel exclusivity	Possible through retailer or manufacturer contracts

The product’s competitive protection is therefore operational. A manufacturer with reliable supply, acceptable dissolution performance, low complaint rates, and controlled pseudoephedrine logistics can win business without holding a broad patent position.

What is the FDA regulatory status and Orange Book position?

The product is an OTC drug subject to FDA requirements for active ingredients, labeling, manufacturing, quality systems, and packaging. Cetirizine and oral pseudoephedrine are established OTC ingredients, but the exact legal pathway depends on the product’s labeling, dosage form, combination, and marketing authorization.

The FDA Drug Facts label must identify the active ingredients, purposes, warnings, directions, and inactive ingredients. Pseudoephedrine products are also subject to federal and state sales controls under the Combat Methamphetamine Epidemic Act, including purchase limits, identification requirements, recordkeeping, and retail access restrictions (U.S. Congress, 2005).

A conventional private-label OTC product is generally not an Orange Book-listed product in the same manner as an approved prescription NDA product. Orange Book relevance must be assessed against the specific FDA application and NDC configuration. A product marketed under an OTC monograph pathway normally does not create a Paragraph IV litigation pathway comparable to a prescription generic seeking approval under an ANDA.

Are Paragraph IV challenges likely for All Day Allergy-D?

Paragraph IV challenges are unlikely to be the primary competitive mechanism for this product. Paragraph IV litigation is associated mainly with ANDA applicants challenging listed patents for prescription products. A store-brand OTC cetirizine-pseudoephedrine product generally enters through an OTC regulatory route or a product-specific authorization that does not create the same patent-certification framework.

Competitive entry is more likely to occur through:

• Another retailer’s private-label product.
• A contract-manufactured OTC equivalent.
• A branded product discount.
• A formulation change with improved packaging or release performance.
• A substitution from 12-hour to 24-hour allergy therapy.
• A switch from pseudoephedrine to phenylephrine-containing products, although clinical and regulatory considerations differ.

What excipient strategy offers the best commercial opportunity?

The strongest strategy is a cost-controlled hydrophilic matrix tablet supported by a validated dissolution method and a high-throughput compression process.

Recommended technical priorities

Priority	Commercial rationale
Robust extended-release matrix	Reduces batch failures and complaint risk
Low-segregation blend design	Protects cetirizine content uniformity
Moisture-controlled packaging	Supports shelf life and dissolution stability
Short, scalable manufacturing process	Lowers conversion cost
Moderate tablet size	Improves patient acceptance
Strong film coat	Reduces chipping and improves private-label appearance
Multi-source excipient qualification	Reduces supply-chain dependence
Discriminating dissolution method	Detects release drift before commercialization

The formulation should avoid unnecessary excipient complexity. Each additional excipient adds qualification, supplier management, analytical work, and potential label burden. A simple matrix system with well-characterized excipients may offer better economics than a technically elaborate multilayer or multiparticulate design unless the latter provides a measurable release or stability advantage.

What commercial opportunities exist for Good Neighbor Pharmacy All Day Allergy-D?

Private-label margin expansion

The primary opportunity is substitution for branded Zyrtec-D. Retailers can offer a lower-priced product while preserving pharmacy-channel availability and store-brand margin. The product is suitable for seasonal allergy campaigns and front-end pharmacy merchandising, subject to pseudoephedrine access restrictions.

Pack-size and channel optimization

Commercial opportunities include:

• Small trial packs for seasonal demand.
• Larger-count packages where legal and operationally appropriate.
• Blister packaging for dose tracking.
• Unit-dose or pharmacy-dispensed formats.
• E-commerce reservation with in-store identification verification.
• Retailer-specific packaging and loyalty-program pricing.

Pseudoephedrine controls limit unrestricted online fulfillment. Packaging and channel design must account for identification requirements and transaction records.

Product-line extensions

The same platform can support:

• A 24-hour cetirizine-only tablet.
• A 12-hour or 24-hour pseudoephedrine combination, if supported by the applicable regulatory pathway.
• Children’s formulations with age-appropriate dosing.
• Liquid or orally disintegrating presentations for cetirizine-only products.
• Seasonal allergy bundles combining oral therapy with nasal or ophthalmic products.

Each extension creates new labeling, stability, consumer-safety, and manufacturing requirements. The highest-value extensions are likely those that reuse existing supply-chain capabilities without introducing a difficult new dosage form.

Excipient and manufacturing licensing

A company with validated release-control know-how could license:

• A low-cost pseudoephedrine matrix platform.
• A dissolution-stable coating system.
• A segregation-resistant direct-compression process.
• A moisture-protective blister configuration.
• A multi-source excipient package with established regulatory documentation.

The licensable asset is more likely to be a formulation and process package than a broad composition patent.

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

The patent estate is likely weak as a standalone barrier to generic or private-label entry because the active ingredients are old, the therapeutic use is established, and competing products are available. Patent strength would improve only if a sponsor owned valid, enforceable claims directed to a specific extended-release composition, manufacturing process, or package configuration.

Patent factor	Assessment
Active-ingredient patents	Minimal practical relevance
Method-of-use patents	Limited value for established OTC indications
Extended-release formulation claims	Possible but likely narrow
Manufacturing-process claims	Potentially useful if non-obvious and difficult to design around
Packaging claims	Usually limited commercial blocking power
Trade dress and retailer brand	More relevant than pharmaceutical exclusivity
Biosimilar risk	Not applicable; this is a small-molecule OTC product

Biosimilar risk does not apply because cetirizine and pseudoephedrine are chemically synthesized small molecules. The relevant threat is generic and private-label substitution.

What litigation and settlement risks affect the product?

The principal litigation risks are unlikely to involve Paragraph IV patent suits. More relevant issues include:

• Product liability claims involving pseudoephedrine warnings.
• Labeling and consumer-protection disputes.
• Manufacturing deviations affecting dissolution or content uniformity.
• Trademark or trade-dress disputes.
• Contract disputes between retailer, label owner, and contract manufacturer.
• FDA enforcement related to cGMP, labeling, or unapproved marketing.

Settlement agreements involving this type of OTC product would more likely concern commercial supply, trademarks, distribution, or manufacturing claims than delayed generic entry.

What is the competitive outlook for All Day Allergy-D?

The competitive set includes branded Zyrtec-D, store-brand cetirizine-pseudoephedrine products, cetirizine-only products, loratadine products, fexofenadine products, and non-pseudoephedrine decongestant combinations.

Product segment	Competitive advantage	Limitation
Cetirizine-pseudoephedrine 12-hour	Combined allergy and congestion relief	Behind-counter controls
Cetirizine-only 24-hour	Simple dosing and broad availability	Does not directly address congestion
Branded Zyrtec-D	Consumer recognition	Higher price
Private-label equivalent	Lower price and retailer margin	Lower brand recognition
Nasal decongestant products	Local delivery potential	Different adherence and tolerability profile

Revenue exposure is seasonal and depends on allergy intensity, retailer distribution, inventory availability, and the price gap versus branded products. The product has greater value as part of a private-label allergy portfolio than as a patent-protected standalone asset.

Key Takeaways

• Good Neighbor Pharmacy All Day Allergy-D is typically a 12-hour extended-release combination of cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg.
• The main excipient opportunity is controlled pseudoephedrine release through a robust hydrophilic matrix.
• Content uniformity, dissolution stability, moisture protection, and tablet manufacturability have greater commercial importance than novel excipient selection.
• The product has limited conventional exclusivity and is unlikely to depend on Paragraph IV litigation.
• Biosimilar risk is irrelevant; private-label and generic substitution are the principal competitive threats.
• Pseudoephedrine transaction controls materially affect packaging, distribution, e-commerce, and inventory strategy.
• Commercial differentiation is most credible through lower cost, reliable supply, strong packaging, retailer execution, and line extensions.
• A formulation patent could protect a specific release system, but the likely patent estate is narrower and weaker than that of a novel prescription product.

FAQs

Does All Day Allergy-D use a controlled-release excipient?

Yes. A 12-hour cetirizine-pseudoephedrine tablet requires a release-control system, commonly based on a hydrophilic polymer matrix or a comparable extended-release technology.

Can a manufacturer replace the inactive ingredients without changing the product?

Only if the revised formulation remains compliant with the applicable FDA pathway and continues to meet identity, strength, quality, stability, dissolution, labeling, and manufacturing requirements.

Is pseudoephedrine subject to special packaging rules?

Pseudoephedrine products are subject to federal sales, identification, recordkeeping, and quantity restrictions under the Combat Methamphetamine Epidemic Act. Retail implementation also varies by state.

Is Good Neighbor Pharmacy All Day Allergy-D a biosimilar?

No. It is a small-molecule OTC drug product. Generic and private-label competition, rather than biosimilar competition, determines market risk.

Can a retailer obtain exclusive rights to an All Day Allergy-D formulation?

A retailer may negotiate exclusive supply, private-label, trademark, packaging, or distribution rights. Exclusivity over the underlying active ingredients is generally unavailable because cetirizine and pseudoephedrine are established compounds.

References

1. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Title VII of the USA PATRIOT Improvement and Reauthorization Act, Pub. L. No. 109-177.

2. U.S. Food and Drug Administration. (n.d.). DailyMed: Cetirizine hydrochloride and pseudoephedrine hydrochloride extended-release tablet labeling. National Library of Medicine.

3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugsatfda

4. U.S. Food and Drug Administration. (n.d.). Over-the-counter drug monograph system and nonprescription drug requirements. https://www.fda.gov/drugs

5. United States Pharmacopeia. (2024). United States Pharmacopeia and National Formulary. U.S. Pharmacopeial Convention.