List of Excipients in Branded Drug SIGNATURE CARE CHILDRENS 12 HOUR COUGH RELIEF

« Back to Dashboard

Generic Drugs Containing SIGNATURE CARE CHILDRENS 12 HOUR COUGH RELIEF

Company	Ingredient	NDC	Excipient
Safeway	dextromethorphan polistirex	21130-890	D&C RED NO. 30
Safeway	dextromethorphan polistirex	21130-890	FD&C BLUE NO. 1
Safeway	dextromethorphan polistirex	21130-890	GLYCERIN
Safeway	dextromethorphan polistirex	21130-890	HIGH FRUCTOSE CORN SYRUP
Safeway	dextromethorphan polistirex	21130-890	METHYLPARABEN

What are the Most Frequently-Used Excipients in SIGNATURE CARE CHILDRENS 12 HOUR COUGH RELIEF?

# Of NDCs	Excipient
2	D&C RED NO. 30
2	FD&C BLUE NO. 1
2	GLYCERIN
2	HIGH FRUCTOSE CORN SYRUP
2	METHYLPARABEN

Signature Care Children’s 12-Hour Cough Relief: Excipient Strategy and Commercial Opportunities

Last updated: October 4, 2026

Signature Care Children’s 12 Hour Cough Relief is positioned as a private-label, extended-release dextromethorphan product competing primarily with Delsym Children’s 12 Hour Cough Relief. Its commercial value depends less on active-ingredient differentiation than on suspension stability, palatability, dosing accuracy, package usability, and retailer economics.

The core formulation strategy is an aqueous suspension of dextromethorphan polistirex, supported by polymeric suspension aids, sweeteners, buffering agents, preservatives, flavor, and viscosity control. The strongest commercial opportunities are lower-cost formulation architecture, improved pediatric acceptability, preservative reduction, sustainable packaging, and retailer-exclusive variants.

What is Signature Care Children’s 12 Hour Cough Relief?

Signature Care Children’s 12 Hour Cough Relief is an over-the-counter pediatric cough suppressant marketed under the Signature Care private-label brand. The product is generally associated with dextromethorphan polistirex, an extended-release form of dextromethorphan intended to provide cough suppression over approximately 12 hours.

Attribute	Product position
Brand	Signature Care
Category	OTC pediatric cough suppressant
Likely active ingredient	Dextromethorphan polistirex
Dosage form	Oral liquid suspension
Release profile	Extended release, approximately 12 hours
Primary comparator	Delsym Children’s 12 Hour Cough Relief
Regulatory pathway	OTC drug monograph or monograph-compliant private label
Commercial owner	Retailer/private-label supply chain
Main differentiation	Price, flavor, package size, availability, and retailer trust

The precise active-ingredient strength, inactive-ingredient list, package configuration, and manufacturer should be confirmed against the current package label and DailyMed record before regulatory filing, sourcing, or litigation analysis.

What excipients are used in a 12-hour dextromethorphan suspension?

A typical dextromethorphan polistirex suspension uses excipients in five functional groups: suspension control, release control, taste management, chemical protection, and dose-delivery support.

Excipient function	Typical materials	Commercial purpose
Polymer-resin drug complex	Polistirex or related ion-exchange resin	Controls dextromethorphan release
Suspending agent	Xanthan gum, cellulose derivatives, or equivalent polymer	Prevents rapid settling
Sweetener and bodying agent	Sorbitol, sucrose, glycerin, or equivalent	Improves taste and mouthfeel
Buffer	Sodium citrate, citric acid, phosphate system	Controls pH and stability
Preservative	Methylparaben, propylparaben, sodium benzoate, or equivalent	Controls microbial growth
Solubilizer or co-solvent	Propylene glycol or glycerin	Supports flavor and preservative systems
Chelating agent	Disodium EDTA	Limits metal-catalyzed degradation
Flavor	Grape, berry, or other pediatric flavor	Supports acceptance and repeat use
Colorant	Product-specific approved color	Visual identity
Vehicle	Purified water	Continuous liquid phase

The release-controlling resin is central to the product’s performance. Dextromethorphan polistirex is not equivalent to a conventional dextromethorphan hydrobromide syrup from a formulation-development perspective. The active is incorporated into a polymeric complex that must remain physically stable while releasing drug in the gastrointestinal tract.

The principal development risk is not simply dissolution. It is the interaction among resin particle size, drug loading, ion-exchange behavior, suspension viscosity, pH, ionic strength, and gastrointestinal release conditions.

How should the excipient system be optimized?

Suspension stability

A pediatric 12-hour suspension must remain redispersible after storage and shipping. Excessive viscosity can improve sedimentation resistance but create dosing problems, poor pourability, and an unpleasant mouthfeel. Insufficient viscosity can produce hard settling and dose nonuniformity.

Xanthan gum is commercially attractive because it provides strong low-shear suspension performance at relatively low concentrations. Cellulose-based polymers can improve mouthfeel or reduce the perception of sliminess, but they may require tighter control of hydration, temperature, and mixing order.

A development program should measure:

• Sedimentation volume over shelf life
• Redispersibility after controlled storage
• Dose uniformity from beginning, middle, and end of bottle use
• Pour rate through the marketed dosing device
• Viscosity across relevant shear rates
• Stability after freeze-thaw and elevated-temperature exposure

Taste and mouthfeel

The product is administered to children, making taste a direct commercial variable. Dextromethorphan has a bitter taste, while polymeric suspensions can create a coating or slimy sensation.

The most practical taste strategy combines:

1. Reduced free-drug exposure in the mouth through resin binding.
2. A high-intensity flavor system, commonly grape or berry.
3. Sweetener and polyol balancing.
4. Buffer optimization to reduce bitterness perception.
5. Controlled viscosity that avoids excessive oral coating.

Sorbitol can improve sweetness and body while limiting crystallization risk. Glycerin can support mouthfeel and flavor distribution. High polyol levels, however, may create gastrointestinal tolerability concerns and can affect osmolality.

Flavor development should use pediatric sensory testing where permitted and should evaluate aftertaste, bitterness onset, duration, and acceptability after repeated use.

Preservative system

Aqueous pediatric products are exposed to repeated opening and dosing-device contact. Preservative selection therefore affects both microbial safety and consumer positioning.

Paraben-based systems are technically established but may be less attractive for “clean label” marketing. Sodium benzoate or potassium sorbate systems can support a paraben-free positioning, but their effectiveness is pH-dependent and must be demonstrated through preservative-effectiveness testing.

A preservative-reduction strategy could use:

• Lower microbial-risk packaging
• A narrower bottle opening
• Unit-dose or stick-pack formats
• Improved manufacturing controls
• Compatible pH adjustment
• A validated antimicrobial packaging system

Removing a preservative without replacing its function would create a regulatory and quality risk. The opportunity is to redesign the complete product-package system rather than merely delete an ingredient.

pH and buffer design

The buffer should support preservative effectiveness, flavor stability, resin performance, and chemical stability. Sodium citrate and citric acid are common choices because they offer familiar regulatory status and acceptable taste.

The formulation should avoid unnecessary ionic strength. Counterions and buffer concentration can affect ion-exchange behavior and may change the release profile of the polymer-drug complex. pH screening should therefore evaluate both long-term stability and in vitro release.

Dosing accuracy

The label dose for pediatric products can depend on age and measurement volume. A formulation with high viscosity or rapid settling can produce clinically meaningful dose variation if the bottle is not shaken adequately.

Commercially valuable package improvements include:

• A calibrated oral syringe rather than a cup-only presentation
• A bottle with a narrow-neck adapter
• Clear “shake well” instructions
• A dosing device with age-specific measurement marks
• Packaging that reduces residual product trapped in the closure

Dose-delivery design can provide greater practical differentiation than small changes in flavor or color.

What formulation patents protect extended-release dextromethorphan products?

The main intellectual-property value in this category is generally concentrated in the extended-release drug-resin system, particle engineering, suspension stability, and manufacturing process rather than in basic excipients such as glycerin, citric acid, or xanthan gum.

The commercial product should be assessed across four patent categories:

Patent category	Potential claim focus	Relevance to Signature Care
Drug-resin complex	Dextromethorphan bound to a polymeric resin	High
Particle engineering	Particle size, drug loading, coating, or distribution	High
Oral suspension	Viscosity, redispersibility, dose uniformity, and stability	Moderate to high
Manufacturing method	Loading, washing, drying, blending, and suspension processing	Moderate
Packaging	Dosing device or child-resistant closure	Low to moderate
Basic excipients	Sweeteners, buffers, flavors, and preservatives	Usually low

A private-label product using an established OTC active ingredient generally does not receive the same type of product-specific regulatory exclusivity associated with an innovative prescription drug. Patent exposure depends on the supplier’s formulation, manufacturing process, and use of any proprietary extended-release technology.

The key diligence issue is whether the supplier is using a licensed or independently manufactured dextromethorphan polistirex material. A retailer can reduce formulation risk by sourcing a qualified active-resin complex from an established manufacturer, but that approach can increase supply concentration and licensing dependence.

What is the FDA regulatory status of this product?

Dextromethorphan products are regulated as OTC cough suppressants under the FDA monograph framework, subject to applicable conditions for active ingredients, labeling, dosage, warnings, and product quality. The relevant OTC framework is in 21 C.F.R. Part 341, while general OTC labeling requirements also apply under 21 C.F.R. Part 201.

Key regulatory requirements include:

• Compliance with the applicable OTC cough-and-cold monograph framework
• Accurate declaration of active and inactive ingredients
• Pediatric dosing and warning language
• Child-resistant packaging under applicable requirements
• Stability data for the marketed container-closure system
• Microbial limits and preservative effectiveness
• Dose uniformity throughout the bottle
• Demonstration that the extended-release profile remains controlled

Because this is an OTC private-label product, it is generally not analyzed as an Orange Book-listed prescription product. The relevant regulatory risks are monograph compliance, product-quality failures, labeling errors, manufacturing deviations, and consumer adverse-event exposure.

What commercial opportunities exist for Signature Care?

Retailer price architecture

The primary opportunity is private-label margin expansion. Retailers can price the product below Delsym while preserving acceptable gross margin through:

• Larger procurement volumes
• Standardized bottle and closure components
• Common flavor systems across cough products
• Contract manufacturing
• Dual sourcing of excipients
• Reduced secondary packaging

The strongest cost levers are usually packaging, active-resin procurement, flavor systems, filling efficiency, and contract-manufacturer scale.

Premium pediatric positioning

A private-label product can support a higher price tier if it improves use experience. Potential claims must remain consistent with regulatory requirements, but commercial concepts include:

• Easier-to-measure dosing
• Better taste
• Paraben-free formulation
• Alcohol-free formulation
• Reduced artificial color
• Recyclable packaging
• Syringe included
• Smaller bottle for travel or school use

The commercial value of “better taste” is high but difficult to establish without controlled sensory testing and substantiated consumer research.

Preservative-free or low-preservative formats

A preservative-free product could differentiate from conventional multidose syrups through unit-dose packaging. The tradeoff is higher packaging cost, more complex filling, and potentially lower shelf efficiency.

Possible formats include:

• Single-dose sachets
• Blow-fill-seal unit doses
• Small premeasured oral tubes
• Multi-dose bottles with antimicrobial closure technology

This format is more likely to succeed in travel, urgent-care, and e-commerce channels than in low-price mass retail unless manufacturing scale is achieved.

Sustainability

Packaging is a visible point of differentiation. Opportunities include:

• Lightweight high-density polyethylene bottles
• Recycled plastic content where compatible with product protection
• Reduced carton use
• Paper-based dosing instructions
• Concentrated or smaller-volume formats

Sustainability claims must be reconciled with child-resistant packaging, moisture protection, product compatibility, and recycling infrastructure.

Adjacent portfolio expansion

The same excipient and packaging platform can support a family of pediatric OTC products:

• Immediate-release dextromethorphan
• Children’s expectorant products
• Combination cough-and-cold products where legally appropriate
• Nighttime cough products
• Flavor variants
• Age-specific dose presentations

A common bottle, cap, label stock, and dosing device can lower SKU complexity. The principal risk is accidental product confusion, particularly when multiple pediatric products have similar colors and graphics.

How does Signature Care compare with Delsym?

Factor	Signature Care	Delsym
Brand strength	Retailer private label	Established national brand
Likely active	Dextromethorphan polistirex	Dextromethorphan polistirex
Main advantage	Price and retailer availability	Brand recognition and consumer familiarity
Differentiation potential	Flavor, dosing device, package, price	Brand equity and formulation history
Patent leverage	Usually supplier-dependent	More likely tied to proprietary formulation history
Retail economics	Potentially higher retailer margin	Higher branded acquisition cost
Consumer trust	Retailer-dependent	National-brand dependent
Innovation pathway	Packaging and excipients	Product-line extensions and brand marketing

Signature Care is unlikely to win through active-ingredient differentiation. It can compete through lower price, stronger shelf placement, improved dosing hardware, and better private-label execution.

What manufacturing and supply-chain barriers exist?

The most important manufacturing barrier is consistent production of the drug-resin complex and its integration into a stable suspension. Small process changes can affect release rate, sedimentation, and dose uniformity.

Key supply risks include:

• Dependence on a limited number of resin suppliers
• Variability in resin particle-size distribution
• Inconsistent drug loading
• Flavor and preservative compatibility
• High-shear processing that damages the suspension structure
• Filling variation caused by viscosity
• Bottle and closure adsorption
• Long lead times for child-resistant components

A dual-source strategy should be established for noncritical excipients and packaging components. The active-resin complex may require a more controlled single-source or qualified dual-source approach because supplier changes can trigger comparative release, stability, and process-validation work.

What are the highest-value formulation opportunities?

The most commercially attractive opportunities are ranked below.

Opportunity	Commercial value	Technical difficulty	Regulatory burden
Better dosing syringe and bottle adapter	High	Low to moderate	Moderate
Lower-cost suspension system	High	Moderate	Moderate
Improved grape or berry flavor	High	Moderate	Moderate
Paraben-free preservative system	Moderate to high	Moderate	Moderate
Preservative-free unit dose	High	High	High
Sustainable packaging	Moderate	Moderate	Moderate
Novel release-control resin	High	High	High
New active ingredient	Low for this product	Very high	High

The best near-term strategy is to preserve the established extended-release active while optimizing excipients, package delivery, and sensory performance. A new resin or materially different release system may create stronger intellectual-property value but would increase development, regulatory, and manufacturing risk.

Key Takeaways

• Signature Care Children’s 12 Hour Cough Relief competes as a private-label extended-release dextromethorphan product.
• The drug-resin complex, not the sweetener or flavor, is the core technical element.
• Suspension stability, redispersibility, taste, preservative control, and dose accuracy determine commercial performance.
• The product is generally governed by the OTC cough-suppressant regulatory framework rather than prescription-drug exclusivity.
• Orange Book and Paragraph IV analysis are generally not the primary commercial issues for this OTC product.
• The strongest near-term opportunities are improved dosing hardware, flavor optimization, lower-cost excipient systems, and retailer-exclusive packaging.
• The largest technical risks involve resin variability, release-profile changes, microbial control, and dose nonuniformity.
• Product and process patents should be reviewed at the supplier and formulation level, especially for the dextromethorphan-resin complex.

FAQs

Is dextromethorphan polistirex an excipient?

No. Dextromethorphan polistirex is the active pharmaceutical ingredient in an extended-release drug-resin complex. The resin component controls drug release but is part of the active complex rather than a conventional inactive excipient.

Can Signature Care use the same excipients as Delsym?

It can use comparable functional excipients, but the products may not be compositionally identical. A private-label manufacturer must establish stability, microbial control, dose uniformity, sensory acceptability, and release performance for its own formulation.

Which excipient is most important for 12-hour performance?

The drug-resin complex is most important. Suspending agents, buffers, ionic strength, and processing conditions can also influence release behavior by affecting particle distribution and the surrounding liquid phase.

Is a preservative-free pediatric cough suspension commercially feasible?

Yes, but a preservative-free multidose bottle requires strong microbial-control measures. Unit-dose packaging is more technically defensible but usually carries higher manufacturing and packaging costs.

Does a better flavor create patent protection?

Usually not by itself. Flavor selection generally provides limited patent protection unless it is part of a novel, technically defined formulation that produces a measurable stability, taste-masking, or release advantage.

References

1. U.S. Food and Drug Administration. (2024). Over-the-counter monograph M012: Cough and cold, oral under 21 CFR part 341.
2. U.S. Food and Drug Administration. (2024). DailyMed: Dextromethorphan polistirex oral suspension labeling. National Library of Medicine.
3. U.S. Food and Drug Administration. (2024). Guidance for industry: Nonsterile semisolid dosage forms: Scale-up and postapproval changes.
4. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary.
5. Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 201: Labeling.
6. Electronic 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.