List of Excipients in Branded Drug GOOD SENSE COUGH DM

Generic Drugs Containing GOOD SENSE COUGH DM

Company	Ingredient	NDC	Excipient
L Perrigo Company	dextromethorphan polistirex	0113-0384	D&C RED NO. 30 ALUMINUM LAKE
L Perrigo Company	dextromethorphan polistirex	0113-0384	D&C YELLOW NO. 10 ALUMINUM LAKE
L Perrigo Company	dextromethorphan polistirex	0113-0384	GLYCERIN

What are the Most Frequently-Used Excipients in GOOD SENSE COUGH DM?

# Of NDCs	Excipient
3	D&C RED NO. 30
1	D&C RED NO. 30 ALUMINUM LAKE
3	D&C YELLOW NO. 10

Good Sense Cough DM Excipient Strategy and Commercial Opportunities

Last updated: September 17, 2026

Good Sense Cough DM is an over-the-counter combination cough product built around dextromethorphan hydrobromide, a cough suppressant, and guaifenesin, an expectorant. The standard U.S. liquid presentation uses dextromethorphan HBr 10 mg and guaifenesin 100 mg per 5 mL. Its commercial opportunity is primarily a cost-efficient, palatable, stable liquid platform rather than a patent-protected drug product.

The highest-value excipient strategies are sugar-free reformulation, alcohol-free positioning, improved taste masking, reduced viscosity, preservative optimization, dye-free presentation, and packaging that reduces dosing error. The active ingredients are old, widely available and generally accessible through the OTC monograph pathway. Competitive differentiation must therefore come from formulation performance, retail execution, price, packaging and consumer claims.

What is Good Sense Cough DM?

Good Sense Cough DM is a private-label or store-brand cough-and-cold product generally marketed as an oral liquid containing:

Attribute	Typical product profile
Active ingredient 1	Dextromethorphan hydrobromide
Pharmacologic role	Cough suppressant
Active ingredient 2	Guaifenesin
Pharmacologic role	Expectorant
Typical strength	Dextromethorphan HBr 10 mg and guaifenesin 100 mg per 5 mL
Dosage form	Oral liquid
Regulatory category	U.S. OTC drug
Principal users	Adults and children above the labeled minimum age
Commercial category	Store-brand cough, cold and flu
Patent position	No material composition-of-matter patent barrier for the established actives

The exact inactive-ingredient profile can differ by size, flavor, manufacturer and national market. A typical formulation may include purified water, sweeteners, glycerin, sorbitol, citric acid, sodium citrate, flavor, color and sodium benzoate. The current package label and product-specific Drug Facts panel control for a particular Good Sense SKU.

What excipients are used in Good Sense Cough DM?

The liquid formulation requires excipients that solve five technical problems: solubilization, taste masking, microbial control, pH management and consumer acceptability.

Typical excipient functions

Excipient class	Likely function in the formulation	Commercial importance
Purified water	Vehicle	Primary bulk phase
Glycerin	Co-solvent, sweetener, mouthfeel modifier	Helps reduce harshness and improves viscosity
Sorbitol	Sweetener and humectant	Supports sugar-free positioning
High-fructose corn syrup or sucrose	Sweetening and body	Low-cost, familiar taste but limits diabetic-friendly positioning
Citric acid	Acidulant and flavor modifier	Controls pH and improves taste
Sodium citrate	Buffer	Supports pH stability
Sodium benzoate	Preservative	Controls microbial growth in an aqueous product
Flavor system	Taste masking	Critical for dextromethorphan bitterness
Colorant	Product identification and consumer appeal	Can create sensitivity and clean-label limitations
Chelating agent, if used	Metal-ion control	May improve stability and preservative performance

Dextromethorphan has a strong bitter taste that becomes commercially important in a liquid dosage form. Guaifenesin can add a bulky, medicinal mouthfeel. The formulation therefore needs more than simple sweetening. A successful taste system normally combines sweetness, acidity, flavor masking and mouthfeel control.

How should the excipient strategy be optimized?

1. Build a sugar-free liquid platform

A sugar-free version can use sorbitol, glycerin, sucralose, acesulfame potassium or combinations of these excipients. The primary commercial advantages are:

• Broader appeal among consumers limiting sugar.
• Better compatibility with diabetic-friendly retail positioning.
• Lower risk of crystallization than high-sugar systems.
• Platform reuse across cough, cold and expectorant products.

Sorbitol and glycerin can produce laxation concerns at high intake levels, while intense sweeteners can leave an aftertaste. The target should be a balanced sweetener system rather than maximum sweetness.

2. Improve bitter taste masking

Taste masking is the most important formulation opportunity for Good Sense Cough DM. Options include:

• Flavor combinations based on cherry, grape, berry, citrus or honey profiles.
• Acidulants that reduce bitterness without creating excessive sourness.
• Ion-pairing or complexation approaches for dextromethorphan.
• Encapsulated or coated active particles for more advanced products.
• Viscosity adjustment to reduce immediate taste exposure.
• Cooling or warming sensory modifiers.

A highly viscous vehicle can prolong oral residence and increase bitterness. A lower-viscosity, fast-swallowing formulation may improve acceptability if it maintains dose uniformity and consumer-perceived quality.

3. Use an alcohol-free positioning

Alcohol-free cough products have a broad retail advantage. The formulation can rely on water, glycerin, propylene glycol, sorbitol and suitable flavor solvents rather than ethanol.

Alcohol-free positioning supports:

• Family-oriented marketing.
• Wider pharmacy and grocery distribution.
• Use by consumers avoiding alcohol.
• Simplified retailer compliance policies.
• Lower concern about accidental exposure in children.

The formulation must still demonstrate flavor solubilization, preservative efficacy and stability without ethanol.

4. Reassess colors and dyes

A dye-free version can target consumers seeking simpler ingredient lists. Removing FD&C colorants may reduce visual differentiation on the shelf, but it can improve the product's appeal in pharmacies and online channels where ingredient scrutiny is higher.

A practical portfolio could include:

Product variant	Consumer proposition
Standard flavored liquid	Lowest-cost mass-market product
Sugar-free	Reduced-sugar positioning
Dye-free	Simplified ingredient profile
Alcohol-free	Family and broad-access positioning
Premium taste-masked liquid	Higher price and better adherence
Single-dose stick packs	Portability and controlled dosing

What regulatory pathway applies to Good Sense Cough DM?

Good Sense Cough DM is regulated as an OTC drug. Dextromethorphan and guaifenesin are established OTC active ingredients subject to FDA conditions for use under the cough-cold regulatory framework, including 21 C.F.R. Part 341 and the current OTC monograph system (FDA, 2024a; FDA, 2024b).

A compliant product must address:

• Active ingredient identity and concentration.
• Permitted indications.
• Required warnings and directions.
• Age restrictions.
• Labeling format.
• Manufacturing under current good manufacturing practices.
• Stability and expiration dating.
• Preservative effectiveness where applicable.
• Container-closure integrity.
• Dose-measuring device suitability.

The manufacturer must avoid unsupported claims such as treating asthma, pneumonia or chronic bronchitis unless a separate approved drug application supports them. Permitted claims generally relate to temporary relief of cough and loosening of phlegm, subject to the applicable monograph conditions and label requirements.

What FDA exclusivity and patent protections apply?

The active ingredients have been marketed for decades. Good Sense Cough DM does not rely on a new chemical entity exclusivity period, and the established active ingredients are not protected by meaningful composition-of-matter patents that would block ordinary OTC competition.

Protection category	Relevance to Good Sense Cough DM
New chemical entity exclusivity	Not applicable
New drug exclusivity	Not the normal route for the established OTC actives
Orange Book patent listing	Typically not central to a monograph-compliant OTC product
Paragraph IV litigation	Low relevance for a standard monograph product
Formulation patents	Possible only for genuinely novel formulation technology
Trademark protection	Relevant to Good Sense branding and trade dress
Trade secret protection	Relevant to flavor systems, processing and supplier specifications
Regulatory exclusivity	Generally not the principal commercial barrier

A novel formulation using encapsulated dextromethorphan, controlled release, a new delivery device or a distinctive stability system could support patent filings. A conventional syrup using common sweeteners, buffers and preservatives would have weak patentability.

What formulations are protected by patents?

The commercially defensible opportunity is not the basic combination of dextromethorphan and guaifenesin. It is a differentiated delivery or consumer-use feature.

Potentially protectable areas include:

Taste-masked oral liquids

A patent strategy could focus on a specific combination of coating materials, particle size, polymer ratios, flavoring system and dissolution profile. Broad claims covering "a sweetened cough syrup" would face substantial prior-art risk.

Extended-release formulations

A sustained-release product could create a higher-value platform, but it would require evidence that the release profile provides a meaningful therapeutic or dosing benefit. Manufacturing complexity and regulatory requirements would increase.

Unit-dose packaging

Single-use sachets, orally measured cups or metered dosing devices may support device or packaging claims. The strongest position would come from reduced dosing error or improved product stability rather than packaging appearance alone.

Low-sugar or sugar-free systems

A sugar-free formulation alone is unlikely to create a strong patent position. Patentability would depend on an unexpected technical result, such as improved stability, superior taste masking or reduced preservative concentration.

How strong is the patent estate for Good Sense Cough DM?

The patent estate is weak for the standard product but can become moderate for a technically differentiated platform.

Asset	Estimated commercial defensibility
Dextromethorphan active	Very low
Guaifenesin active	Very low
Conventional syrup vehicle	Very low
Standard flavor system	Low
Sugar-free formulation	Low to moderate
Advanced taste masking	Moderate
Metered-dose delivery system	Moderate
Extended-release liquid	Moderate to strong if clinically differentiated
Brand and trade dress	Moderate
Manufacturing know-how	Moderate but difficult to enforce externally

Because the product is largely a commodity OTC formulation, cost of goods, supply continuity and retailer placement are more important than patent exclusivity.

What manufacturing and IP barriers affect commercial entry?

Manufacturing entry is relatively accessible, but liquid OTC products have recurring technical risks.

Key manufacturing risks

• Incomplete dissolution of dextromethorphan.
• Guaifenesin crystallization or sedimentation.
• Flavor instability over shelf life.
• Preservative loss or inadequate antimicrobial performance.
• Color drift.
• pH movement.
• Inconsistent fill volume.
• Dose nonuniformity.
• Container interaction.
• Microbial contamination during filling.

A robust process should control order of addition, mixing temperature, pH, preservative dispersion and fill-line sanitation. Supplier qualification is important for flavors, sweeteners and preservatives because small changes can alter taste and stability.

The most defensible manufacturing know-how may involve the flavor and preservative system, active dissolution sequence and scale-up controls. These measures can support trade-secret protection even when the finished formulation cannot support broad patent claims.

Which companies challenge Good Sense Cough DM commercially?

The product competes with branded and private-label products rather than with patent challengers. The main competitor groups include:

Competitor group	Examples
Branded cough products	Robitussin, Delsym, Mucinex
Retail private labels	CVS Health, Walgreens, Walmart Equate, Rite Aid and supermarket brands
E-commerce private labels	Amazon Basic Care and other online brands
Combination cold products	Products pairing cough actives with analgesics, antihistamines or decongestants
Specialty products	Sugar-free, dye-free, alcohol-free and natural-positioned liquids

Robitussin and Mucinex have stronger consumer recognition. Private-label products generally compete on price. Delsym competes through extended-release dextromethorphan and a distinct dosing proposition, which makes it a useful benchmark for premium positioning.

How does Good Sense Cough DM compare with competing products?

Product type	Main advantage	Main weakness	Excipient opportunity
Standard dextromethorphan/guaifenesin syrup	Low cost and broad indication	Commodity positioning	Improve taste and dose accuracy
Extended-release dextromethorphan	Less frequent dosing	Higher price and narrower active profile	Develop longer-lasting combination delivery
Branded expectorant product	Recognition and retail visibility	Premium price	Match taste and packaging at lower cost
Sugar-free syrup	Reduced sugar	Sweetener aftertaste or laxation risk	Optimize sweetener blend
Dye-free syrup	Cleaner label	Less visual differentiation	Use packaging and flavor identity
Single-dose sachets	Convenience and portability	Higher packaging cost	Target travel, workplace and e-commerce

What commercial opportunities exist?

Premium private-label reformulation

A retailer could maintain the standard low-cost SKU while adding a premium version with:

• Sugar-free excipients.
• No artificial colors.
• Alcohol-free formulation.
• Improved taste masking.
• Dose cup or oral syringe.
• Tamper-evident, child-resistant packaging.

This creates a tiered portfolio without abandoning the base product.

E-commerce and subscription sales

Cough products have seasonal demand and are suitable for online replenishment. Single-dose or compact packaging can reduce shipping complexity and improve portability. Search-driven sales also favor clear claims such as "sugar-free," "alcohol-free" and "dye-free," provided they are accurate.

Contract manufacturing and licensing

A formulation owner could license:

• A taste-masking system.
• A stable sugar-free vehicle.
• A metered-dose package.
• A private-label finished product.
• A multi-active cough-and-cold platform.

The most credible licensing proposition is a validated formulation with stability, sensory data and scale-up performance. A patent application alone would have limited value without manufacturing evidence.

Geographic expansion

The United States is the strongest market for a Good Sense-style OTC product because of established monograph pathways and large private-label channels. Expansion into Canada, the European Union and selected Asia-Pacific markets would require country-specific review of:

• Dextromethorphan scheduling.
• Guaifenesin status.
• Permitted excipients.
• Label language.
• Pediatric warnings.
• Maximum package sizes.
• Marketing authorization requirements.

Excipient choices may need regional adjustment. For example, certain dyes, preservatives and sweeteners face different consumer or regulatory sensitivities across markets.

What generic launch risks exist?

Generic or private-label entry risk is high because the actives are established and the formulation is comparatively simple. The primary barriers are commercial, not legal.

A new entrant can usually compete by:

1. Matching the active concentrations.
2. Using a monograph-compliant label.
3. Sourcing common pharmaceutical excipients.
4. Contracting with an OTC liquid manufacturer.
5. Offering a lower retail price or improved package format.

The principal launch risks are product recalls, microbial failure, inaccurate dosing devices, poor taste, supply interruptions and retailer rejection. A differentiated excipient platform can reduce price competition, but only if consumers notice a meaningful benefit.

What litigation and settlement issues affect the product?

Standard Good Sense Cough DM is unlikely to face material Paragraph IV litigation because it does not depend on a recently approved, patent-listed drug. Litigation risk is more likely to involve:

• Trademark or trade-dress disputes.
• False or misleading labeling claims.
• Product liability.
• Manufacturing defects.
• Advertising claims.
• Retailer or supplier disputes.
• Patent disputes involving a novel delivery device or formulation.

Settlement agreements are not a normal feature of the basic product's market access. They become relevant only if a manufacturer adopts a patented extended-release, taste-masking or dosing technology owned by another company.

Key Takeaways

• Good Sense Cough DM is a mature OTC dextromethorphan-guaifenesin product with limited patent-based exclusivity.
• The standard formulation is commercially accessible and vulnerable to private-label competition.
• Taste masking, sugar-free excipients, alcohol-free positioning and dose-control packaging offer the strongest product-development opportunities.
• Conventional sweetener, buffer and preservative combinations have weak patent potential.
• Advanced taste masking, extended release and metered delivery may support stronger IP if backed by technical data.
• FDA compliance, preservative effectiveness, stability and dosing accuracy are the primary development requirements.
• Commercial value is driven by retailer access, cost of goods, flavor performance and packaging rather than by active-ingredient exclusivity.
• A two-tier portfolio, combining a low-cost standard syrup with a premium sugar-free or dye-free variant, is the most practical strategy.

FAQs About Good Sense Cough DM Excipient Strategy

Is Good Sense Cough DM sugar-free?

The answer depends on the specific SKU. Good Sense cough products are sold in different formulations, and the Drug Facts panel must be checked for sucrose, corn syrup, sorbitol and other sweeteners.

Can dextromethorphan and guaifenesin be formulated without preservatives?

A preservative-free product is technically possible in some package formats, but an aqueous multidose syrup generally requires validated microbial-control measures. Unit-dose packaging, aseptic processing or a low-water-activity formulation may reduce preservative dependence.

What is the best flavor for a dextromethorphan-guaifenesin syrup?

Cherry, grape and berry profiles are common commercial choices. The best flavor depends on the dextromethorphan concentration, sweetener system, pH and target age group.

Can a sugar-free Good Sense Cough DM formulation be patented?

Sugar-free status alone is unlikely to support strong patent protection. A patent case would require a novel formulation architecture or unexpected result, such as superior taste masking or improved stability.

Is Good Sense Cough DM subject to biosimilar competition?

No. Dextromethorphan and guaifenesin are small-molecule OTC actives, not biologics. The relevant competitive risks are generic, private-label and branded OTC products rather than biosimilars.

References

1. Food and Drug Administration. (2024a). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (2024b). Over-the-counter monograph M012: Cough, cold, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. U.S. Department of Health and Human Services.

3. Food and Drug Administration. (2024c). Drug products marketed without an approved application: OTC monograph reform. U.S. Department of Health and Human Services.

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

5. Food and Drug Administration. (2024d). Current good manufacturing practice regulations for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. U.S. Department of Health and Human Services.