List of Excipients in Branded Drug MEMBERS MARK MUCUS RELIEF DM

Generic Drugs Containing MEMBERS MARK MUCUS RELIEF DM

Company	Ingredient	NDC	Excipient
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	CARBOMER HOMOPOLYMER TYPE B
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	CELLULOSE, MICROCRYSTALLINE
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	COPOVIDONE K25-31
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	D&C YELLOW NO. 10 ALUMINUM LAKE
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	HYPROMELLOSE
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	MAGNESIUM HYDROXIDE
Sam's West Inc	dextromethorphan hbr, guaifenesin	68196-812	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in MEMBERS MARK MUCUS RELIEF DM?

# Of NDCs	Excipient
2	CARBOMER HOMOPOLYMER TYPE B
2	CELLULOSE, MICROCRYSTALLINE
1	COPOVIDONE K25-31
1	D&C YELLOW NO. 10 ALUMINUM LAKE
1	FD&C BLUE NO. 1
1	FERRIC OXIDE YELLOW
1	HYPROMELLOSE

Member’s Mark Mucus Relief DM: Excipient Strategy, Regulatory Position and Commercial Opportunities

Last updated: August 1, 2026

Member’s Mark Mucus Relief DM is a private-label extended-release cough and mucus product combining guaifenesin and dextromethorphan hydrobromide. The principal commercial opportunity is not active-ingredient exclusivity. It is a low-cost, compliant solid-dose platform that improves tablet manufacturability, release control, swallowability, stability, and retail differentiation.

The product is generally positioned as an extended-release tablet containing 600 mg guaifenesin and 30 mg dextromethorphan hydrobromide per tablet, dosed every 12 hours. Its regulatory pathway is based on FDA’s OTC cough-cold monograph framework rather than a conventional new-drug approval. The product therefore has limited protection from drug patents, Orange Book listings, or prescription-style market exclusivity.

What is Member’s Mark Mucus Relief DM?

Member’s Mark Mucus Relief DM is a Costco private-label OTC product for cough suppression and mucus relief.

Attribute	Product position
Brand	Member’s Mark
Retailer	Costco Wholesale
Active ingredients	Guaifenesin and dextromethorphan hydrobromide
Typical strength	600 mg guaifenesin and 30 mg dextromethorphan per extended-release tablet
Dosage form	Oral extended-release tablet
Therapeutic category	Expectorant and antitussive
Dosing interval	Typically every 12 hours
Regulatory route	OTC monograph pathway
Primary commercial competitors	Mucinex DM, store-brand guaifenesin-dextromethorphan products, generic extended-release tablets
Patent profile	Primarily formulation and manufacturing risk, not active-ingredient exclusivity
Orange Book status	OTC monograph products are generally not listed in the Orange Book as approved prescription products

Guaifenesin is an expectorant. Dextromethorphan suppresses cough through a centrally acting antitussive mechanism. Combining the two allows the product to address both productive mucus and cough symptoms within one tablet.

What excipients are used in Member’s Mark Mucus Relief DM?

The inactive ingredients for a particular Member’s Mark package should be confirmed against the current package insert or DailyMed listing because private-label products can change manufacturers and formulations. Extended-release guaifenesin-dextromethorphan tablets commonly use a hydrophilic matrix and standard direct-compression or granulation excipients.

A typical excipient architecture can include:

Excipient function	Common materials	Role in the formulation
Matrix former	Hypromellose	Controls water penetration and drug diffusion
Diluent	Microcrystalline cellulose	Provides tablet bulk and compressibility
Binder	Povidone or pregelatinized starch	Improves granule and tablet strength
Disintegrant	Sodium starch glycolate or crospovidone	Supports breakup of non-matrix portions
Lubricant	Magnesium stearate	Reduces ejection force and tooling friction
Glidant	Colloidal silicon dioxide	Improves powder flow
Film former	Hypromellose, polyethylene glycol, or related coating polymers	Protects the tablet and improves appearance
Colorant	FDA-permitted color system	Supports product identification
Opacifier	Titanium dioxide or alternative opacifier, where used	Controls coating opacity
Processing aid	Purified water or alcohol used during manufacture	Removed or controlled during drying

The formulation challenge is unusually important because guaifenesin is present at a high dose while dextromethorphan is present at a much lower dose. The formulation must distribute the lower-dose active uniformly without compromising the extended-release behavior of the high-dose expectorant.

How does the extended-release tablet work?

The most practical platform is a hydrophilic polymer matrix. After ingestion, the tablet hydrates at the surface. The polymer forms a gel layer that controls penetration of gastrointestinal fluid and release of the active ingredients.

Hydrophilic matrix strategy

Hypromellose is the principal candidate for this function because it is widely used, scalable, and available in multiple viscosity grades. Polymer concentration, viscosity, particle size, and compression force affect:

• Initial drug release
• Twelve-hour release performance
• Tablet erosion
• Sensitivity to agitation
• Food-effect behavior
• Tablet size and hardness
• Batch-to-batch reproducibility

A high-viscosity hypromellose grade can reduce rapid release but can increase tablet size, slow processing, and raise the risk of incomplete drug release. A lower-viscosity grade can improve manufacturability but may require a higher polymer load or additional matrix-forming materials.

Bilayer or multiparticulate alternatives

A bilayer tablet could separate guaifenesin and dextromethorphan release zones, but it would increase manufacturing complexity. Multiparticulate pellets or coated granules could provide more precise release control, but they would raise unit cost and require additional coating equipment.

For a value-oriented Costco product, these technologies are most commercially useful if they solve a specific problem, such as improved dose uniformity, lower tablet weight, better food-effect performance, or easier swallowing.

Which excipients create the largest commercial opportunity?

The strongest opportunities are in excipient substitution and process simplification rather than new pharmacology.

1. Lower-cost matrix systems

A manufacturer could evaluate hypromellose against combinations of:

• Polyethylene oxide
• Hydroxypropyl cellulose
• Carbomer
• Ethylcellulose
• Pregelatinized starch
• Xanthan gum

The replacement must preserve the dissolution profile and remain compatible with OTC labeling. A lower-cost matrix can improve gross margin if it reduces polymer loading, compression force, coating time, or material waste.

2. Direct-compression platforms

Direct compression can reduce wet-granulation steps and shorten manufacturing time. The main constraints are the high guaifenesin load, powder segregation, flow, and tablet robustness.

Microcrystalline cellulose, silicified microcrystalline cellulose, spray-dried mannitol, and co-processed excipients can improve flow and compactibility. Co-processed systems are particularly relevant when a high-dose active produces weak tablets or poor weight uniformity.

3. Taste and mouthfeel improvement

Although an extended-release tablet is swallowed whole, taste can become relevant if the tablet chips, is split, or begins to disintegrate in the mouth. Film coating can reduce bitterness from dextromethorphan and improve consumer acceptance.

Potential coating and sensory strategies include:

• Thicker polymer film coating
• Opacifying coatings
• Ion-exchange resin complexes
• Lipid-based taste barriers
• Low-moisture coating systems
• Reduced-dust tablet surfaces

The label must continue to instruct consumers to swallow the tablet whole where the dosage form is not intended to be split or chewed.

4. Lower-risk lubricant systems

Magnesium stearate is inexpensive and familiar but can create hydrophobicity when overused or overmixed. Alternative or complementary lubricants include sodium stearyl fumarate and stearic acid systems.

The opportunity is process optimization rather than simple replacement. Lubricant concentration, blend time, and order of addition can affect dissolution, tensile strength, ejection force, and content uniformity.

5. Film-coating efficiency

Coating is a meaningful cost center for high-volume OTC products. A coating system that reduces spray time, drying energy, or weight gain can improve throughput.

Commercially relevant options include:

• Higher-solids aqueous coating systems
• Lower-viscosity polymer dispersions
• Pigment concentrates
• Reduced-weight coatings
• Continuous coating processes
• Low-temperature coating systems for moisture-sensitive formulations

A coating change must preserve tablet identification, stability, appearance, and dissolution.

What FDA rules govern the product?

Member’s Mark Mucus Relief DM is generally regulated under FDA’s OTC monograph system for cough, cold, bronchodilator, and antiasthmatic products. The relevant regulatory framework includes FDA’s monograph provisions for oral expectorants and antitussives, current good manufacturing practice requirements, labeling rules, and general OTC drug requirements (FDA, 2022; 21 C.F.R. Parts 210 and 211).

Guaifenesin and dextromethorphan are established OTC actives. The commercial formulation must comply with:

• Permitted active ingredients and concentrations
• Required indications and warnings
• Dosage instructions
• Labeling format
• Manufacturing controls
• Stability requirements
• Identity, strength, quality, and purity standards
• Packaging and tamper-evident requirements, where applicable

The excipient itself does not need a separate FDA approval if it is used in a compliant drug formulation. The sponsor remains responsible for demonstrating that the finished product is safe, effective under the monograph framework, stable, and manufactured consistently.

What is the Orange Book status of Member’s Mark Mucus Relief DM?

Member’s Mark Mucus Relief DM is not expected to have the same Orange Book profile as a prescription product approved under an NDA or ANDA.

The FDA Orange Book primarily identifies approved prescription drug products and certain approved nonprescription products approved through an NDA or ANDA. A private-label OTC monograph product generally does not obtain an Orange Book patent listing that would generate a traditional Paragraph IV certification pathway.

This distinction reduces patent-based launch barriers. A competing manufacturer usually does not need to resolve an Orange Book-listed formulation patent before marketing a compliant OTC monograph product.

When does Member’s Mark Mucus Relief DM lose exclusivity?

The product has no conventional prescription exclusivity period based on the public OTC monograph framework.

Exclusivity category	Status
New chemical entity exclusivity	Not applicable
Five-year NDA exclusivity	Not applicable
Three-year clinical-investigation exclusivity	Not applicable
Orphan exclusivity	Not applicable
Pediatric exclusivity	Not applicable unless separately awarded, which is not the commercial structure here
OTC monograph exclusivity	No product-specific monopoly comparable to NDA exclusivity
Orange Book patent exclusivity	Generally not applicable to the private-label monograph product
Trademark protection	Member’s Mark branding and trade dress may be protected
Formulation know-how	Potentially protected as confidential manufacturing information

The absence of regulatory exclusivity means that competitive entry can occur through compliant store-brand, generic, club-store, pharmacy, and e-commerce products.

Which companies are challenging the product?

The relevant competitive threat is not typically a named Paragraph IV challenger. It is substitution by other OTC manufacturers and retailers.

Direct product competitors

• Reckitt’s Mucinex DM and related guaifenesin-dextromethorphan products
• Perrigo-manufactured store brands
• LNK International and other private-label OTC suppliers
• Major pharmacy chains’ house brands
• Walmart, CVS, Walgreens, Amazon, and supermarket private labels
• Generic extended-release guaifenesin-dextromethorphan manufacturers

The competitive landscape is driven by retail placement, price per dose, package count, supply reliability, consumer recognition, and retailer margin.

What generic entry risks exist?

Generic and private-label entry risk is high because the active ingredients are mature, widely available, and supported by an OTC monograph pathway.

The principal barriers are operational:

1. Developing a reproducible extended-release profile.
2. Achieving acceptable content uniformity for dextromethorphan.
3. Managing high-dose guaifenesin compression.
4. Maintaining tablet integrity during packaging and transport.
5. Meeting stability requirements across temperature and humidity ranges.
6. Avoiding dose dumping or rapid release.
7. Securing reliable supply of compliant excipients and packaging components.

A new entrant can generally compete without replicating the incumbent’s exact excipient composition. It must produce a finished product that meets applicable FDA requirements and performs as labeled.

How strong is the patent estate for Member’s Mark Mucus Relief DM?

The product-specific patent estate is likely weak relative to patented prescription drugs. The active ingredients are long-established, and the commercial product is positioned within a mature OTC category.

Potential IP exposure can still arise from:

• Extended-release matrix architecture
• Coated granules or pellets
• Specific release profiles
• Abuse-deterrent dextromethorphan systems
• Tablet geometry
• Manufacturing processes
• Taste-masking methods
• Stabilization systems
• Packaging configurations
• Trade dress and branding

These rights are more likely to affect a particular formulation or manufacturing route than the entire guaifenesin-dextromethorphan market. A competitor can often design around a formulation patent by changing polymer grades, coating structure, granulation method, or tablet architecture.

What formulation patents could affect competing products?

A competing product should screen patent families covering:

• Hydrophilic matrix tablets containing guaifenesin
• Twelve-hour release of guaifenesin
• Combined guaifenesin and dextromethorphan dosage forms
• Coated dextromethorphan particles
• Ion-exchange resin complexes
• Abuse-deterrent oral formulations
• Controlled-release pellets
• Reduced-size or swallowability-focused tablets
• Moisture-protective packaging and stability systems

Patent risk is highest where a formulation claims a narrow combination of active ratios, polymer ranges, dissolution limits, and manufacturing parameters. Broad claims covering the basic combination of guaifenesin and dextromethorphan are less likely to provide durable exclusivity because the actives and combination are longstanding.

What manufacturing and IP barriers matter most?

The most important manufacturing barrier is control of drug release at commercial scale.

Critical quality attributes

• Assay of both active ingredients
• Content uniformity for dextromethorphan
• Tablet hardness and friability
• Dissolution at multiple time points
• Tablet weight variation
• Moisture content
• Coating uniformity
• Stability under accelerated and long-term conditions
• Packaging integrity

Critical process parameters

• Polymer particle size
• Order of ingredient addition
• Blend time
• Granulation endpoint, if granulation is used
• Compression force
• Press speed
• Lubrication time
• Coating spray rate
• Inlet and outlet temperature
• Residual moisture

Manufacturing know-how can create a practical advantage even where patent protection is limited. A supplier with validated scale-up data, reliable dissolution control, and low reject rates may be more valuable to a retailer than a supplier with a nominally lower material cost.

What licensing deals are relevant?

The commercial model is more likely to involve private-label supply agreements than drug patent licenses. Relevant deal structures include:

• Contract manufacturing agreements
• Development and technology-transfer agreements
• Excipient supplier rebates
• Volume-based pricing contracts
• Retailer-exclusive formulations
• Packaging and artwork supply agreements
• Co-development of extended-release OTC products

A retailer may pursue an exclusive formulation only where it creates a visible consumer or cost advantage. Otherwise, standard monograph-compliant formulations are easier to source from multiple manufacturers.

Excipient suppliers can capture value through preferred-supplier status, technical support, and validated formulation platforms. A co-processed excipient that improves high-dose tablet compression can support a supply agreement without requiring a drug patent license.

How does Member’s Mark compare with Mucinex DM?

Factor	Member’s Mark Mucus Relief DM	Mucinex DM
Business model	Costco private label	Branded OTC product
Core actives	Guaifenesin and dextromethorphan	Guaifenesin and dextromethorphan
Consumer proposition	Value and club-pack economics	Brand recognition and product range
Patent dependence	Low at the product level	May include formulation and brand-related IP
Retail leverage	High through Costco distribution	Broad pharmacy, mass retail, and digital distribution
Excipient opportunity	Cost reduction and scalable manufacturing	Differentiated release, sensory, and dosage-form innovation
Generic substitution risk	High	High, but brand equity may reduce switching
Main commercial defense	Price, package size, availability	Brand, marketing, product breadth, and distribution

The products compete on active-ingredient equivalence, dose form, price per tablet, and consumer trust. Member’s Mark can gain share through lower acquisition cost and large-package economics. Mucinex can defend premium pricing through brand familiarity and line extensions.

What commercial opportunities exist for excipient suppliers?

The most attractive opportunities are platform-based.

Cost-reduction platform

A supplier can offer a co-processed diluent-disintegrant system that improves flow and tablet strength while reducing processing steps. The target customer is a private-label manufacturer seeking lower conversion cost.

Extended-release platform

A calibrated hypromellose or polyethylene oxide system can support multiple guaifenesin strengths and combination products. The value proposition is faster formulation development and a narrower scale-up risk window.

Low-moisture platform

Moisture-controlled excipient systems and high-barrier packaging can improve stability in humid distribution environments. This is relevant for club-store products that may remain in household medicine cabinets for long periods.

Swallowability platform

Smaller tablets, optimized coating, higher tensile strength, and reduced tablet roughness can support consumer-facing differentiation. The formulation must preserve the labeled extended-release profile.

Sustainable coating platform

Water-based, low-solids, or reduced-energy coating systems can lower manufacturing cost and support retailer sustainability targets. The commercial case is strongest when the system also reduces coating time or equipment burden.

What generic launch scenarios are most likely?

Scenario 1: Low-price store-brand substitution

A competing retailer launches a similar 600 mg/30 mg extended-release tablet at a lower price. The main response is purchasing leverage, package-size adjustment, and supply-chain efficiency.

Scenario 2: Formulation-led differentiation

A competitor introduces a smaller tablet, easier-swallow dosage form, or improved coating. The product may command a modest premium if the benefit is clear on the package.

Scenario 3: Supply-constrained entry

A manufacturer enters during a shortage or supply disruption. Manufacturing reliability becomes more important than brand recognition.

Scenario 4: Line extension

A supplier develops additional strengths, liquid products, chewables, or single-ingredient variants. This expands retailer shelf space but increases excipient, stability, and labeling complexity.

What is the revenue exposure for Costco and suppliers?

Costco does not generally report revenue for individual Member’s Mark OTC SKUs. The economic exposure is therefore assessed through category and channel dynamics rather than product-level public revenue.

For Costco, the product contributes through:

• Private-label gross margin
• Pharmacy and front-end traffic
• Member retention
• Basket expansion
• Large-package purchasing
• Retailer control over pricing and assortment

For manufacturers, revenue depends on contract volume, package count, active-ingredient procurement, conversion cost, and retailer exclusivity. Excipient value is usually a small percentage of finished product cost, but an excipient that reduces rejects, improves throughput, or avoids a separate granulation step can materially improve total cost.

What geographic coverage applies?

The product’s primary commercial opportunity is in the United States, where the FDA OTC monograph system governs the marketed product. International expansion would require a jurisdiction-specific assessment.

Key differences may include:

• Active-ingredient status
• Permitted excipients
• Maximum daily doses
• Extended-release terminology
• Warning language
• Packaging requirements
• Stability zones
• Import and manufacturing controls
• Trademark ownership

A U.S. monograph-compliant formulation cannot automatically be commercialized in Canada, the European Union, the United Kingdom, Australia, or other markets without local regulatory review.

Key Takeaways

• Member’s Mark Mucus Relief DM is a mature OTC combination of guaifenesin and dextromethorphan.
• The commercial dosage form is typically a 600 mg/30 mg extended-release tablet.
• The core excipient challenge is controlling twelve-hour release while compressing a high-dose guaifenesin tablet with uniform dextromethorphan distribution.
• Hypromellose matrix systems, direct-compression excipients, film coatings, lubricants, and moisture-control technologies offer the main optimization opportunities.
• The product has no conventional NDA exclusivity or prescription-style Orange Book barrier.
• Paragraph IV litigation is generally not the central launch risk for a compliant OTC monograph product.
• Competition is likely to come from private-label and generic manufacturers rather than a single branded challenger.
• The strongest commercial opportunities are lower-cost matrix systems, co-processed compression platforms, efficient coatings, and validated contract-manufacturing processes.
• Costco’s product-level revenue is not separately disclosed, so commercial value is linked to category economics, retailer margin, and package-volume purchasing.
• Formulation know-how may provide a practical advantage even where patent protection is limited.

FAQs

Is Member’s Mark Mucus Relief DM the same as Mucinex DM?

It has the same general active-ingredient combination, guaifenesin and dextromethorphan, but the products may differ in excipients, tablet design, coating, packaging, manufacturer, and price.

Can a competitor copy the excipients in Member’s Mark Mucus Relief DM?

A competitor may develop a substantially equivalent OTC product without copying the exact excipient composition. It must meet FDA requirements and avoid any enforceable formulation, manufacturing, trademark, or trade-dress rights.

Does guaifenesin require an extended-release polymer?

Not necessarily. The release profile can be controlled through a matrix, coated particles, pellets, multilayer construction, or another validated dosage-form design. Hydrophilic polymers are among the most practical options for a high-dose tablet.

Are OTC guaifenesin-dextromethorphan products subject to Paragraph IV challenges?

Ordinary OTC monograph products generally do not follow the same Orange Book certification process as prescription ANDA products. A formulation patent could still produce litigation, but a standard Paragraph IV challenge is not usually the primary competitive mechanism.

Which excipient change is most likely to reduce manufacturing cost?

A direct-compression or co-processed excipient system that improves powder flow, tablet strength, and content uniformity can reduce granulation, compression, and rejection costs. The benefit must be confirmed through dissolution, stability, and scale-up testing.

References

1. U.S. Food and Drug Administration. (2022). OTC Monograph M012: Cough, cold, allergy, bronchodilator, and anti-asthmatic drug products for over-the-counter human use. https://www.accessdata.fda.gov

2. U.S. Food and Drug Administration. (2024). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

3. Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 210: Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs. https://www.ecfr.gov

4. Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 211: Current good manufacturing practice for finished pharmaceuticals. https://www.ecfr.gov

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

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