List of Excipients in Branded Drug CHILDRENS DYE FREE WAL ZYR

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Generic Drugs Containing CHILDRENS DYE FREE WAL ZYR

Company	Ingredient	NDC	Excipient
Walgreen Company	cetirizine hcl	0363-0953	ANHYDROUS CITRIC ACID
Walgreen Company	cetirizine hcl	0363-0953	PROPYLENE GLYCOL
Walgreen Company	cetirizine hcl	0363-0953	SODIUM BENZOATE
Walgreen Company	cetirizine hcl	0363-0953	SORBITOL

What are the Most Frequently-Used Excipients in CHILDRENS DYE FREE WAL ZYR?

# Of NDCs	Excipient
2	ANHYDROUS CITRIC ACID
2	PROPYLENE GLYCOL
2	SODIUM BENZOATE
2	SORBITOL

Children’s Dye-Free Wal-Zyr: Excipient Strategy, Regulatory Position, and Commercial Opportunities

Last updated: September 25, 2026

Children’s Dye-Free Wal-Zyr is an over-the-counter cetirizine hydrochloride oral solution positioned for pediatric allergy treatment. Its commercial proposition is based on a dye-free liquid, sweetened oral delivery, simple dosing, and private-label pricing rather than patent exclusivity. The principal opportunities are reformulation, packaging, retailer differentiation, and supply-chain efficiency.

The product’s likely active ingredient is cetirizine hydrochloride at 1 mg/mL, equivalent to cetirizine 0.8 mg/mL. The formulation uses common oral-liquid excipients, including a citrate buffer, glycerin, sodium benzoate, sucralose, flavoring, and purified water. Product-level sales, supplier agreements, and retailer margins are not publicly disclosed.

What is Children’s Dye-Free Wal-Zyr?

Children’s Dye-Free Wal-Zyr is a Walgreens private-label pediatric allergy product containing cetirizine hydrochloride. Cetirizine is a second-generation H1 antihistamine used for temporary relief of symptoms associated with allergic rhinitis and chronic urticaria.

Attribute	Product position
Brand	Wal-Zyr
Retailer	Walgreens
Dosage form	Oral solution or syrup
Active ingredient	Cetirizine hydrochloride
Typical strength	1 mg/mL
Patient segment	Children and families seeking liquid allergy treatment
Prescription status	OTC
Colorants	Excluded from the dye-free formulation
Primary differentiation	Dye-free liquid, private-label price, pediatric dosing
Patent dependence	Low
Regulatory basis	OTC monograph pathway and applicable FDA labeling requirements

The product competes with Children’s Zyrtec, generic cetirizine oral solution, store-brand cetirizine products, and alternative antihistamines such as loratadine and fexofenadine.

What excipients are used in Children’s Dye-Free Wal-Zyr?

The listed formulation is understood to include the following functional excipient classes:

Excipient or class	Primary function	Commercial and technical relevance
Glycerin	Humectant, solvent, viscosity modifier, mouthfeel enhancer	Supports palatability and liquid stability
Citric acid	Acidifying agent and buffer component	Helps control pH and preservative performance
Sodium citrate	Buffer component	Stabilizes pH during shelf life
Sodium benzoate	Antimicrobial preservative	Supports microbiological control in an aqueous multidose product
Sucralose	High-intensity sweetener	Improves pediatric acceptability without sucrose
Flavoring	Taste masking and product identity	Major driver of repeat use and caregiver acceptance
Purified water	Vehicle	Main liquid carrier

The product name establishes a dye-free position, but it does not by itself establish that the formulation is free of every excipient associated with consumer concerns. Dye-free products can still contain preservatives, artificial sweeteners, flavors, or other synthetic excipients.

How does the excipient system work?

The formulation depends on coordinated control of pH, sweetness, viscosity, flavor, and microbial protection.

The citric acid and sodium citrate combination provides buffer capacity. The target pH must balance several competing requirements: cetirizine chemical stability, preservative efficacy, flavor performance, and oral tolerability.

Sodium benzoate is most effective in its undissociated form, which is favored at lower pH. Raising the pH to improve taste can reduce preservative effectiveness. The manufacturer therefore has to validate preservative performance across the intended pH range, fill volume, container, and in-use period.

Glycerin contributes sweetness and mouthfeel while helping reduce the perception of bitterness. Sucralose increases sweetness at low concentration. Flavoring is critical because cetirizine liquids can have a medicinal or bitter profile that may affect adherence in children.

What formulation opportunities exist for a dye-free cetirizine product?

The most credible formulation opportunities involve improved tolerability, clean-label positioning, and delivery convenience rather than new pharmacology.

Preservative-reduced or preservative-free formulations

A preservative-free multidose aqueous product would require a different microbial-control strategy. Possible approaches include unit-dose packaging, single-use ampoules, sterile manufacturing, or packaging systems that reduce repeated microbial ingress.

These approaches can increase manufacturing and packaging costs. Their commercial value would depend on a clear consumer benefit, such as use in children whose caregivers seek to minimize preservatives.

Sugar-free and low-sugar positioning

The use of sucralose and glycerin supports a formulation that does not rely on sucrose. A sugar-free claim would require confirmation against the final formulation and applicable labeling rules. A product can be dye-free without being sugar-free, so these claims should not be treated as interchangeable.

A sugar-free, dye-free, alcohol-free pediatric liquid could occupy a stronger premium segment than a conventional store-brand syrup. The commercial tradeoff is higher ingredient and sensory-development cost.

Natural sweetener strategies

Steviol glycosides, monk-fruit extracts, polyols, and blended sweetener systems could support a more natural-label position. These alternatives can introduce bitterness, cooling effects, aftertaste, sedimentation, or gastrointestinal tolerance issues.

A natural sweetener system would need comparative sensory testing against sucralose. Pediatric acceptance, not ingredient novelty, is the relevant commercial endpoint.

Improved flavor systems

Flavor development is a high-value opportunity because caregivers often choose products based on whether a child will reliably take the dose. Potential flavor directions include grape, berry, bubble gum, and fruit blends.

Flavor systems must remain compatible with:

• citrate-buffered pH;
• sodium benzoate;
• plastic container materials;
• flavor adsorption or migration;
• light and oxygen exposure;
• extended shelf life.

Alternative dosing formats

The standard oral syringe remains the most accurate pediatric delivery system. Further opportunities include:

• oral syringes with dose stops;
• integrated bottle adapters;
• unit-dose cups;
• premeasured sachets;
• small-volume concentrated liquids;
• orally disintegrating tablets for older children.

Concentrated liquids can reduce bottle size and shipping cost, but they increase dosing-error risk. Any higher-concentration product would require prominent dosing instructions and a calibrated delivery device.

What is the FDA regulatory status of Children’s Dye-Free Wal-Zyr?

Children’s Dye-Free Wal-Zyr is an OTC product subject to FDA requirements for active ingredients, labeling, dosage, safety, and manufacturing. Cetirizine is recognized as an OTC antihistamine active ingredient under the FDA’s antihistamine monograph framework and related OTC labeling requirements (U.S. Food and Drug Administration, n.d.-a; 21 C.F.R. pt. 341).

The product’s regulatory position is different from that of a prescription drug approved through a standalone New Drug Application. A private-label OTC product may be marketed under the applicable monograph pathway if its formulation, indications, dosage, labeling, and manufacturing comply with the rule.

What is the Orange Book status?

The product is not expected to have a conventional Orange Book patent listing comparable to a prescription NDA product. The Orange Book primarily identifies approved prescription and certain other listed drug products, therapeutic-equivalence evaluations, and patent or exclusivity information associated with approved applications (FDA, n.d.-b).

The practical consequences are significant:

• no conventional Orange Book patent estate is expected to block generic entry;
• Paragraph IV certification is generally not the relevant challenge mechanism;
• market entry depends on OTC monograph compliance, product quality, retailer contracting, and manufacturing capacity;
• formulation patents could still be asserted if a competitor independently patented a specific formulation or package.

When does Children’s Dye-Free Wal-Zyr lose exclusivity?

The product has no meaningful product-specific regulatory exclusivity period comparable to a new prescription drug. Cetirizine’s original compound and core therapeutic use are long past the period of practical market exclusivity.

Exclusivity category	Relevance to Wal-Zyr
New chemical entity exclusivity	Not applicable
Five-year NDA exclusivity	Not applicable to the private-label OTC product
Three-year clinical-investigation exclusivity	Not applicable
Pediatric exclusivity	Not expected to create current product-level protection
Orphan exclusivity	Not applicable
Orange Book patent exclusivity	Not expected
OTC monograph protection	Compliance-based, not a time-limited monopoly
Brand or trade-dress protection	Potentially relevant to packaging and presentation

Cetirizine was introduced decades ago, and generic cetirizine products are widely available. The product’s commercial life therefore depends on retail placement and consumer preference rather than exclusivity.

Are there Paragraph IV challenges or generic launch risks?

A conventional Paragraph IV challenge is unlikely to be relevant because Children’s Dye-Free Wal-Zyr is an OTC private-label product rather than a patent-protected prescription NDA product.

Generic launch risk is high in the ordinary commercial sense. Competing manufacturers can offer cetirizine oral solutions under generic, store-brand, or alternative retail labels. The principal barriers are operational:

• FDA-compliant manufacturing;
• validated preservative systems;
• reliable cetirizine API supply;
• pediatric-compatible flavor development;
• packaging and child-resistance requirements;
• retailer qualification;
• inventory and recall controls.

A competitor does not need to defeat a Wal-Zyr patent portfolio to launch a comparable product. It needs a compliant product, a capable contract manufacturer, and distribution.

What patents protect Children’s Dye-Free Wal-Zyr?

No product-specific patent estate is apparent from the product’s OTC private-label positioning. The likely protection is limited to conventional intellectual-property categories:

IP category	Potential scope
Trademark	“Wal-Zyr” brand and related marks
Trade dress	Label design, package appearance, and shelf presentation
Formulation patent	Possible only if a novel formulation was separately developed and patented
Manufacturing know-how	Mixing order, flavor integration, preservative control, and scale-up parameters
Packaging IP	Device design, closure, adapter, or dose-control features
Supplier confidentiality	API specifications, flavor systems, and manufacturing procedures

The commercial moat is more likely to be contractual and operational than patent-based. Walgreens may benefit from private-label sourcing arrangements, retailer data, shelf positioning, and procurement scale.

How strong is the patent estate for cetirizine compared with competing antihistamines?

Product	Active ingredient	Patent/exclusivity position	Current competitive risk
Wal-Zyr	Cetirizine	Minimal product-specific protection	High
Children’s Zyrtec	Cetirizine	Brand and trade identity; core drug protection expired	High
Generic cetirizine	Cetirizine	No practical compound exclusivity	High
Claritin	Loratadine	Core protection expired; brand remains relevant	High
Allegra	Fexofenadine	Core protection expired; brand and formulations compete	High
Xyzal	Levocetirizine	Core protection expired; brand positioning remains	High

The competitive distinction is therefore based on dosing, flavor, formulation claims, packaging, price, and retailer trust.

What commercial opportunities exist for Walgreens and manufacturers?

Retailer private-label expansion

Walgreens can use cetirizine to build a broader pediatric allergy platform with matching products for different ages, dosage forms, and symptom profiles. A coordinated portfolio could include:

• dye-free cetirizine liquid;
• dye-free loratadine liquid;
• chewable antihistamine tablets;
• saline nasal products;
• pediatric allergy kits;
• travel-size formats;
• seasonal multipacks.

Premium excipient positioning

A premium formulation could use the following claims if supported by the final product and applicable regulations:

• dye-free;
• sugar-free;
• alcohol-free;
• gluten-free;
• artificial-flavor-free;
• preservative-free;
• natural flavor;
• low-volume dosing.

Each added claim narrows formulation flexibility and may increase testing, supplier qualification, and labeling risk. The strongest commercial package is likely a combination of dye-free, sugar-free, alcohol-free, and accurate syringe dosing.

Contract manufacturing opportunities

Manufacturers with liquid-filling, pediatric flavoring, and OTC monograph experience can compete for retailer contracts. The most valuable capabilities include:

• small-batch flavor development;
• high-throughput oral-liquid filling;
• preservative-effectiveness testing;
• extractables and leachables evaluation;
• child-resistant closure assembly;
• flexible packaging for seasonal demand;
• validated cleaning procedures for low-dose actives.

Geographic expansion

The U.S. OTC model does not automatically transfer to other markets. Cetirizine products may be regulated differently in Canada, the European Union, the United Kingdom, Australia, and other jurisdictions. Differences can involve:

• permitted excipients;
• preservative limits;
• pediatric labeling;
• measuring-device requirements;
• claims language;
• product registration;
• local pharmacopoeial standards.

A manufacturer can use the U.S. formulation as a development starting point, but geographic expansion requires jurisdiction-specific regulatory review.

What manufacturing and IP barriers affect generic launch?

The active ingredient is not the main barrier. The difficult elements are quality and execution.

Key risks include:

1. Inconsistent flavor acceptance across pediatric age groups.
2. Preservative failure after repeated bottle opening.
3. Cetirizine assay or content-uniformity variation at low concentration.
4. Flavor loss or container interaction during shelf life.
5. Incorrect dosing devices or confusing age instructions.
6. Supply disruptions for pharmaceutical-grade flavor and preservative materials.
7. Retailer penalties caused by out-of-stocks during allergy seasons.
8. Packaging changes that alter regulatory documentation or stability data.

A formulation patent, if one exists for a specific competitor product, would be only one part of the freedom-to-operate analysis. Trade secrets and supplier agreements can be more difficult to replicate than public patent claims.

What revenue exposure does Wal-Zyr create?

Walgreens does not generally disclose revenue for an individual private-label OTC SKU. Exposure is therefore best assessed through category economics rather than product-level sales.

Cetirizine is a high-volume, low-differentiation category. Revenue sensitivity is driven by:

• spring and fall allergy seasons;
• retailer store traffic;
• private-label penetration;
• price gaps versus Children’s Zyrtec;
• online availability;
• product reviews and flavor acceptance;
• supply continuity.

The main downside risk is substitution by generic cetirizine or another retailer’s private label. The main upside is margin expansion from private-label sourcing and premium excipient positioning.

Key Takeaways

• Children’s Dye-Free Wal-Zyr is an OTC cetirizine liquid whose value is based on price, availability, pediatric usability, and dye-free positioning.
• Its formulation strategy relies on citrate buffering, glycerin, sodium benzoate, sucralose, flavoring, and purified water.
• The product is unlikely to have meaningful Orange Book, patent, or Paragraph IV protection.
• Generic and private-label launch risk is high because cetirizine is an established OTC active with broad competition.
• The strongest commercial opportunities are improved flavor, sugar-free positioning, preservative-reduced packaging, accurate dosing devices, and retailer-specific portfolios.
• Manufacturing know-how, quality systems, seasonal inventory, and retailer contracts are more commercially important than compound patents.
• Product-level revenue is not publicly reported, so exposure should be modeled through category share, seasonal demand, pricing, and private-label margin.

FAQs

Is Children’s Dye-Free Wal-Zyr the same as Children’s Zyrtec?

It contains the same principal active ingredient, cetirizine hydrochloride, but the products may differ in excipients, flavor, packaging, labeling, and price.

Does dye-free mean Children’s Wal-Zyr contains no artificial ingredients?

No. Dye-free means the formulation excludes specified color additives. It may still contain synthetic sweeteners, preservatives, flavors, and other excipients.

Can a company launch a competing cetirizine liquid without licensing Walgreens?

Yes. A competing company generally does not need a Walgreens license to market its own compliant cetirizine OTC product. It must avoid Walgreens trademarks, trade dress, confidential information, and any enforceable formulation or packaging rights.

Is cetirizine oral solution eligible for pharmaceutical substitution?

Substitution depends on the applicable regulatory framework, product labeling, dosage form, strength, and jurisdiction. Retail pharmacy substitution rules for OTC products differ from prescription generic-substitution rules.

What is the most defensible innovation for a pediatric cetirizine liquid?

A validated delivery system that improves dose accuracy and reduces administration failure is likely more defensible commercially than a minor sweetener change. Patentability would depend on the specific device or formulation and the applicable prior art.

References

1. U.S. Food and Drug Administration. (n.d.-a). OTC Monograph M012: Antihistamine drug products for over-the-counter human use. https://www.fda.gov
2. U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugsatfda
3. U.S. Food and Drug Administration. (n.d.-c). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
4. Electronic Code of Federal Regulations. (n.d.). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and anti-asthmatic drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-341
5. National Library of Medicine. (n.d.). DailyMed: Cetirizine hydrochloride oral solution labeling. https://dailymed.nlm.nih.gov/dailymed/