List of Excipients in Branded Drug MUCUS DM EXTENDED RELEASE

Generic Drugs Containing MUCUS DM EXTENDED RELEASE

Company	Ingredient	NDC	Excipient
P & L Development LLC	dextromethorphan hydrobromide and guaifenesin	59726-833	CARBOMER 934
P & L Development LLC	dextromethorphan hydrobromide and guaifenesin	59726-833	CELLULOSE, MICROCRYSTALLINE
P & L Development LLC	dextromethorphan hydrobromide and guaifenesin	59726-833	D&C YELLOW NO. 10
P & L Development LLC	dextromethorphan hydrobromide and guaifenesin	59726-833	HYPROMELLOSE

What are the Most Frequently-Used Excipients in MUCUS DM EXTENDED RELEASE?

# Of NDCs	Excipient
1	CARBOMER 934
2	CARBOMER HOMOPOLYMER TYPE B
4	CELLULOSE, MICROCRYSTALLINE
2	COPOVIDONE K25-31

MUCUS DM Extended Release: Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 1, 2026

MUCUS DM Extended Release is an over-the-counter combination product that typically contains guaifenesin and dextromethorphan hydrobromide in a 12-hour extended-release tablet. Its commercial value depends less on active-ingredient exclusivity than on release-control performance, tablet robustness, taste and swallowability, manufacturing cost, brand positioning, and compliance with the FDA’s OTC cough-and-cold framework.

The main formulation opportunity is to develop a robust hydrophilic matrix that controls release of both actives despite their different dose levels, solubilities, and pharmacologic roles. A lower-cost generic or private-label product can compete if it matches dissolution, physical appearance, labeling, stability, and consumer experience without infringing any enforceable formulation or process rights.

What active ingredients are used in MUCUS DM Extended Release?

MUCUS DM Extended Release products generally use:

Component	Typical strength	Function
Guaifenesin	600 mg	Expectorant
Dextromethorphan hydrobromide	30 mg	Cough suppressant
Dosage form	12-hour extended-release tablet	Sustained delivery

The 600 mg/30 mg combination is associated with the commercial Mucinex DM product family and multiple store-brand equivalents. Product-specific strengths can vary by manufacturer and NDC, so formulation and regulatory analysis must be tied to the exact labeler and product listing.

Guaifenesin is administered at a substantially higher mass than dextromethorphan. The formulation therefore must accommodate a high drug load while maintaining tablet size, mechanical strength, acceptable dissolution, and reliable dose uniformity.

Dextromethorphan hydrobromide introduces separate development considerations. It has a lower dose but can create blend-uniformity and content-uniformity risks when dispersed in a large guaifenesin matrix. Particle-size control, geometric dilution, granulation, and segregation management are important manufacturing variables.

How does the extended-release formulation work?

Most commercial extended-release guaifenesin/dextromethorphan tablets use a hydrophilic matrix or a layered matrix approach. The tablet hydrates after administration, forms a gel barrier, and controls drug diffusion and matrix erosion.

A development platform may use:

• Hypromellose or another hydrophilic polymer as the primary release-control agent.
• Microcrystalline cellulose as a diluent and compression aid.
• Povidone or copovidone as a binder.
• Colloidal silicon dioxide as a glidant.
• Magnesium stearate or sodium stearyl fumarate as a lubricant.
• Crospovidone, croscarmellose sodium, or sodium starch glycolate in carefully controlled amounts where faster wetting or breakup is required.
• Film-coating polymers, plasticizers, pigments, and opacifiers for identification and swallowability.

The central technical challenge is balancing the release profiles of two active ingredients with different physicochemical properties. A formulation that releases guaifenesin correctly may release dextromethorphan too quickly, or the reverse. Polymer grade, viscosity, particle size, compression force, tablet porosity, lubricant concentration, and coating weight can materially change dissolution.

What excipients are most commercially important?

Hypromellose and other matrix polymers

Hypromellose is the leading candidate for a simple, scalable hydrophilic matrix. Higher-viscosity grades generally slow hydration, diffusion, and erosion. Lower-viscosity grades can improve manufacturability and reduce overly slow release.

The commercial opportunity is not limited to selecting a polymer. Developers can differentiate through:

• Polymer grade and viscosity.
• Polymer concentration.
• Granulation location.
• Combination of high- and low-viscosity grades.
• Particle-size distribution.
• Direct compression versus wet granulation.
• Bilayer or multilayer tablet architecture.

A polymer system that meets dissolution specifications across different manufacturing sites has greater licensing value than one that works only under narrow process conditions.

Microcrystalline cellulose and mineral fillers

Microcrystalline cellulose can improve compactibility and tablet integrity, but high levels may alter water penetration and release. Calcium phosphate or other insoluble fillers may increase density and reduce swelling, although they can complicate dissolution development.

For a 600 mg guaifenesin dose, excipient selection is constrained by tablet size. High-density fillers can reduce tablet volume, while excessive low-density excipients can make the tablet too large for consumer use.

Binders and granulation aids

Povidone and copovidone can improve granule strength and reduce segregation between guaifenesin and dextromethorphan. Excessive binder can slow hydration and create hard tablets with delayed drug release.

Wet granulation may improve blend uniformity and compressibility but increases process complexity and drying requirements. Direct compression can reduce capital and operating costs if the active ingredients have suitable flow and compactibility.

Lubricants and glidants

Magnesium stearate can improve ejection and reduce tooling problems, but over-lubrication can produce hydrophobic surfaces and alter dissolution. Sodium stearyl fumarate may provide a different balance between lubrication and wettability.

Colloidal silicon dioxide can improve flow, but its effect depends on surface area, order of addition, and mixing time. These variables should be treated as critical process parameters rather than minor formulation details.

Film coating systems

The coating can improve swallowability, reduce friability, protect the tablet from moisture, and support product identification. A thin immediate-release coating generally has less effect on overall release than the matrix itself, but coating weight and permeability still require control.

Colorants and imprinting support counterfeit resistance and brand recognition. A private-label manufacturer can use a visually distinct tablet while preserving the same active ingredients and dosage form.

What dissolution strategy is required for MUCUS DM Extended Release?

Dissolution is the principal performance barrier for an extended-release generic. The objective is to demonstrate consistent release over the labeled 12-hour period while avoiding dose dumping.

Development should assess:

1. Release of guaifenesin across the full dissolution interval.
2. Release of dextromethorphan hydrobromide at the same sampling points.
3. Performance across multiple pH conditions.
4. Agitation sensitivity.
5. Alcohol-induced release acceleration.
6. Tablet robustness after packaging and storage.
7. Effect of compression force and tablet hardness.
8. Lot-to-lot variability.

A robust product should resist rapid release under altered gastric conditions and should not rely on a narrow dissolution window. Alcohol dose-dumping studies are commercially relevant because matrix tablets can experience accelerated polymer disruption or increased drug solubilization in alcohol-containing media.

The commercial advantage of an excipient system is strongest when it delivers a wide process-design space. A formulation that tolerates ordinary variation in granulation endpoint, compression force, and coating weight reduces manufacturing rejects and technology-transfer risk.

What FDA regulatory pathway applies?

A conventional MUCUS DM Extended Release product is generally regulated as an OTC cough-and-cold drug if its active ingredients, strengths, dosage form, labeling, and conditions of use conform to the applicable FDA OTC framework.

Relevant regulatory mechanisms include:

Regulatory issue	Commercial effect
OTC monograph compliance	Can support marketing without a conventional product-specific NDA for a conforming product
Drug Facts labeling	Limits claims, directions, warnings, and consumer positioning
Current good manufacturing practice	Requires validated control of content uniformity, dissolution, stability, and process parameters
NDC listing	Identifies the labeler, product, package, and marketed configuration
FDA establishment registration	Required for applicable manufacturing and distribution operations
Postmarket reporting	Applies to complaints, adverse events, and quality defects

FDA rules for OTC cough, cold, bronchodilator, and antiasthmatic products are principally located in 21 C.F.R. Part 341. The FDA’s OTC monograph system was revised through the CARES Act framework, which changed the legal structure for many nonprescription drug monographs. Product claims and formulations still must conform to the applicable FDA requirements. [1,2]

What is the Orange Book status of MUCUS DM Extended Release?

A product marketed solely under the OTC monograph pathway generally does not have the same Orange Book patent-certification profile as an approved prescription NDA product. The relevant commercial question is whether the exact product is marketed under an NDA, an OTC monograph, or another regulatory basis.

For a conventional OTC monograph product:

• An Orange Book Paragraph IV certification is generally not the central entry mechanism.
• Product-specific patent listings may not be available in the same way as for an NDA product.
• Formulation and process patents can still create litigation risk if valid and enforceable.
• Trademark rights and trade dress can affect market entry even when patent barriers are limited.

The MUCUS DM name may also be protected as a trademark, but a competitor can generally market a product under a different brand or store-brand name if it avoids confusingly similar branding and complies with labeling rules.

What patents protect extended-release guaifenesin and dextromethorphan products?

The strongest potential patent categories are:

Patent category	Typical claim scope	Relevance
Extended-release matrix	Polymer composition, drug-to-polymer ratio, release profile	High
Bilayer tablet	Separate immediate- and extended-release layers	High if used
Multi-particulate system	Pellets, beads, coated particles, capsule or tablet assembly	Medium to high
Manufacturing process	Granulation, compression, coating, curing, or particle treatment	Medium
Abuse-deterrent or tamper-resistant design	Physical or chemical resistance	Product-dependent
Packaging and moisture control	Usually narrow and less commercially decisive	Low to medium
Method of use	Twelve-hour cough and mucus treatment	Often limited in OTC context

Historical extended-release guaifenesin products have been associated with formulation and delivery-system patents, particularly where the claims cover a specific controlled-release architecture. Patent strength depends on claim construction, prosecution history, validity, written description, enablement, and whether a competing formulation falls within the claims.

A competitor should not assume that an expired pioneer patent eliminates all risk. Later-filed patents can cover narrower polymer systems, manufacturing methods, tablet architectures, or specific dissolution profiles. The relevant analysis requires a live patent search by assignee, inventors, active ingredient, dosage form, and jurisdiction.

When does MUCUS DM Extended Release lose exclusivity?

The active ingredients themselves are long-established OTC substances and do not provide meaningful new-molecule exclusivity. Commercial exclusivity is instead driven by:

• Brand recognition.
• Distribution agreements.
• Retailer placement.
• Formulation patents.
• Manufacturing know-how.
• Product reviews and consumer repeat purchase.
• Regulatory compliance.
• Supply reliability.

For monograph-compliant products, there may be no single patent expiration date that determines generic entry. Entry can occur through private-label, store-brand, and branded-generic channels, subject to formulation development, regulatory compliance, trademark clearance, and manufacturing qualification.

The practical exclusivity period for a branded product is therefore commercial rather than statutory. A retailer can often source an equivalent active-ingredient product from multiple contract manufacturers once a technically acceptable formulation is available.

What generic launch risks exist?

A generic or private-label launch faces five principal risks.

Formulation equivalence

The product must achieve the required extended-release performance. A tablet that releases either active ingredient too quickly may create safety, efficacy, and regulatory problems.

Consumer acceptability

A large tablet can reduce adherence. Bitter taste, gritty mouthfeel, excessive tablet hardness, difficult swallowing, or visible tablet defects can reduce repeat purchase even if the product meets specifications.

Manufacturing scale-up

The formulation must transfer from laboratory equipment to commercial granulators, tablet presses, coaters, and packaging lines without changing dissolution.

Supply chain

Guaifenesin is a high-load active ingredient. Supplier qualification, particle-size consistency, impurity control, and inventory planning are important. Dextromethorphan hydrobromide has a smaller dose but requires reliable content uniformity.

Retail economics

OTC cough-and-cold products are price-sensitive. A private-label product may need to compete against national brands while preserving retailer margin. Packaging, advertising, slotting, and seasonal inventory can materially affect profitability.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can pursue several opportunities around MUCUS DM Extended Release.

Premium release-control systems

A pre-engineered hydrophilic matrix platform can reduce formulation time and improve technology transfer. Suppliers with excipients supported by dissolution data, compaction profiles, and scale-up evidence have an advantage over commodity suppliers.

Co-processed excipients

Co-processed systems that combine filler, binder, and flow functionality may simplify direct compression. The value proposition is strongest where the system supports high drug loading and reduces lubricant sensitivity.

Low-moisture and moisture-resistant systems

Guaifenesin products may benefit from excipient and packaging systems that improve stability under high humidity. Moisture-resistant coatings, desiccant-compatible packaging, and low-water-activity excipients can support longer shelf life.

Taste and swallowability technologies

Although the dosage form is a tablet, film coating and surface engineering can reduce bitterness and improve swallowing. Smaller tablets, caplet shapes, smooth coatings, and lower-friction surfaces have direct consumer value.

Continuous manufacturing

A continuous blending and compression platform may reduce segregation risk and improve process control for the low-dose dextromethorphan component. The opportunity is greater for manufacturers seeking flexible production of multiple OTC strengths.

Global regulatory packages

An excipient supplier with toxicology, compendial, allergen, residual-solvent, and regional regulatory documentation can reduce qualification time across the United States, Canada, Latin America, and selected European markets.

How does MUCUS DM Extended Release compare with competing products?

Product type	Primary advantage	Main limitation
Branded guaifenesin/dextromethorphan ER tablet	Consumer recognition and retail presence	Higher price and brand-cost structure
Store-brand equivalent	Lower price and retailer margin	Less brand loyalty
Immediate-release combination	Simpler formulation	More frequent dosing
Guaifenesin-only ER product	Lower formulation complexity	No cough-suppression component
Dextromethorphan-only product	Targeted cough suppression	No expectorant component
Liquid combination product	Easier swallowing for some consumers	Sugar, alcohol, flavor, packaging, and dosing issues
Capsule or multiparticulate system	Potentially improved release control	Higher manufacturing and packaging cost

The principal competitive axis is convenience: two active ingredients in a single 12-hour dosage form. The principal vulnerability is that the product is technically more complex than a single-ingredient immediate-release product.

What litigation and licensing issues affect the product?

No product-specific litigation or licensing conclusion should be drawn from the product name alone. The exact labeler, NDC, formulation, and manufacturing site determine the relevant rights.

The main legal diligence areas are:

• Active formulation patents.
• Controlled-release polymer claims.
• Bilayer or multiparticulate claims.
• Manufacturing-process patents.
• Trademark rights in MUCUS DM, Mucinex DM, and related marks.
• Trade dress and tablet appearance.
• Contract manufacturing and distribution agreements.
• Patent assignments and licenses involving guaifenesin delivery systems.

Biosimilar risk is not relevant because guaifenesin and dextromethorphan are small-molecule active ingredients, not biologics. The relevant competitive threat is generic and private-label substitution.

Key Takeaways

• MUCUS DM Extended Release generally combines guaifenesin 600 mg with dextromethorphan hydrobromide 30 mg in a 12-hour tablet.
• The core technical opportunity is a hydrophilic matrix that controls two actives with different dose levels and release behavior.
• Hypromellose grade, polymer concentration, granulation method, compression force, and lubricant level are major formulation variables.
• OTC monograph compliance, rather than new-drug exclusivity, is likely to define the regulatory route for a conventional product.
• Patent risk is concentrated in formulation architecture, manufacturing processes, and delivery systems rather than the active ingredients.
• Private-label and generic entry opportunities are substantial if dissolution, tablet size, stability, labeling, and consumer acceptability are controlled.
• Excipient suppliers can differentiate through high-drug-load matrices, direct-compression platforms, moisture protection, and scale-up data.
• Biosimilar risk does not apply; generic substitution and retailer competition are the relevant commercial threats.

FAQs

Can MUCUS DM Extended Release be reformulated without hypromellose?

Yes. Other hydrophilic polymers, insoluble matrix formers, multiparticulate systems, or coated-particle technologies can be evaluated. The replacement must deliver an equivalent extended-release profile and remain manufacturable at the required guaifenesin drug load.

Is a bilayer tablet commercially superior to a single-layer matrix?

Not automatically. A bilayer design can separate the active ingredients or provide different release phases, but it adds equipment, process controls, and scale-up risk. A single-layer matrix is usually simpler if it can meet both dissolution profiles.

Are excipient patents important for OTC cough products?

They can be. Broad composition claims may be difficult to sustain for mature technologies, but narrower claims covering polymer ratios, tablet structures, manufacturing conditions, or dissolution characteristics can still affect freedom to operate.

What packaging is appropriate for extended-release guaifenesin products?

High-barrier blister packs and tightly sealed bottles are common options. The preferred system depends on moisture sensitivity, shelf-life targets, child-resistant requirements, unit-dose economics, and retail presentation.

Can a private-label manufacturer use the same active ingredients and strengths?

Generally, a private-label manufacturer can market a compliant equivalent using the same active ingredients and strengths under a different brand, subject to FDA requirements, trademark clearance, patent analysis, manufacturing controls, and applicable labeling rules.

References

1. U.S. Food and Drug Administration. (2023). Over-the-counter monograph M012: Cough-cold, bronchodilator, and antiasthmatic drug products for over-the-counter human use. FDA.

2. 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. U.S. Government Publishing Office.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

4. DailyMed. (2024). Guaifenesin and dextromethorphan hydrobromide extended-release tablet labeling. National Library of Medicine.

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