List of Excipients in Branded Drug MUCUS RELIEF ER DM

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	CARBOMER HOMOPOLYMER TYPE B
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	CELLULOSE, MICROCRYSTALLINE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	HYPROMELLOSE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	MAGNESIUM STEARATE
KROGER COMPANY	MUCUS RELIEF ER DM	guaifenesin and dextromethorphan hydrobromide	30142-991	SODIUM STARCH GLYCOLATE TYPE A POTATO

Mucus Relief ER DM Excipient Strategy, Formulation Economics, and Commercial Opportunities

Last updated: September 25, 2026

Mucus Relief ER DM is an extended-release combination of guaifenesin and dextromethorphan hydrobromide, generally sold as a 600 mg/30 mg tablet. The commercial opportunity is primarily in robust, low-cost extended-release matrix technology, improved tablet swallowability, abuse-deterrent differentiation, packaging, and private-label supply. The product category is typically regulated under the FDA over-the-counter cough, cold, and allergy monograph framework rather than through a conventional prescription NDA, provided the formulation, labeling, dosage, and claims comply with applicable requirements.[1]

The strongest excipient strategy is a controlled-release hydrophilic matrix that separates the release behavior of the two active ingredients. Guaifenesin requires sustained expectorant exposure, while dextromethorphan must provide antitussive activity without excessive early release or dose dumping. A formulation that uses a single undifferentiated matrix may be less effective than a bilayer or functionally segregated tablet.

What is Mucus Relief ER DM?

Mucus Relief ER DM is a dual-active extended-release oral tablet containing:

Component	Typical strength	Pharmacologic role
Guaifenesin	600 mg	Expectorant
Dextromethorphan hydrobromide	30 mg	Antitussive
Dosage form	Extended-release tablet	Usually dosed every 12 hours

The exact inactive-ingredient composition depends on the manufacturer, NDC, and product version. Retail products using the Mucus Relief naming convention can be manufactured by different private-label suppliers. The formulation should therefore be evaluated by NDC and Drug Facts label rather than by brand name alone.

How does the dosage form work?

The product is generally designed to release active ingredients over approximately 12 hours. Guaifenesin is relatively high-load, while dextromethorphan is present at a much lower concentration. This creates different formulation requirements:

• Guaifenesin can dominate tablet mass and affect compression, porosity, and hydration.
• Dextromethorphan hydrobromide requires uniform distribution at a lower dose.
• The release system must resist rapid liberation of either active.
• The tablet must remain manufacturable at commercial compression speeds.
• The finished dosage form must maintain dissolution performance after exposure to humidity and temperature.

What excipients are most important for Mucus Relief ER DM?

The key excipient classes are release-controlling polymers, fillers, binders, lubricants, glidants, wetting agents, and coating materials. A practical formulation normally uses multiple excipient functions rather than relying on one polymer.

Excipient class	Candidate materials	Primary function
Hydrophilic matrix former	Hypromellose, polyethylene oxide	Controls water penetration and drug diffusion
Filler	Microcrystalline cellulose, lactose, dibasic calcium phosphate	Provides tablet mass and compression properties
Binder	Povidone, copovidone, pregelatinized starch	Improves granule and tablet strength
Disintegrant or pore former	Crospovidone, croscarmellose sodium	Adjusts hydration and internal porosity
Lubricant	Magnesium stearate, sodium stearyl fumarate	Reduces ejection force and tooling adhesion
Glidant	Colloidal silicon dioxide	Improves powder flow
Film coat	Hypromellose, polyvinyl alcohol, polyethylene glycol	Improves appearance, handling, and swallowability
Taste and odor control	Film coating, flavor barrier, polymer seal coat	Reduces exposure of dextromethorphan-related taste

Which controlled-release polymer is the best starting point?

Hypromellose is usually the strongest starting point because it is widely used, commercially available, supported by extensive regulatory precedent, and compatible with direct compression or wet granulation. Polymer viscosity, concentration, particle size, and substitution grade materially affect release.

Higher-viscosity hypromellose generally slows hydration and drug diffusion. A lower-viscosity grade can provide faster hydration and more rapid initial release. Combining grades can widen the development window and reduce dependence on a single supplier.

Polyethylene oxide can provide strong matrix integrity and slower erosion, but it may introduce processing and stability considerations. Polymer selection should be based on dissolution performance, not only on nominal viscosity.

How should the formulation separate guaifenesin and dextromethorphan release?

A single matrix is commercially attractive but technically constrained. Guaifenesin and dextromethorphan have different dose levels, solubility behavior, and therapeutic objectives. Three architecture options are commercially relevant.

Single homogeneous matrix

Both actives are blended into one controlled-release matrix.

Advantages include:

• Lower manufacturing complexity
• Lower tooling and validation cost
• Simplified scale-up
• Fewer critical process parameters

The principal risk is limited independent control over each active’s release profile. Adjusting polymer content to control guaifenesin may cause dextromethorphan release to become too slow or too rapid.

Bilayer tablet

One layer is optimized for guaifenesin extended release, while the second layer contains dextromethorphan in an immediate-release or modified-release system.

Advantages include:

• Independent control of the two actives
• Potentially stronger differentiation from simple matrix products
• Greater flexibility in matching branded dissolution behavior
• Opportunity for color or layer identification

Disadvantages include:

• Higher equipment cost
• Greater sensitivity to layer weight, bonding, and compression force
• More complex in-process controls
• Higher risk of delamination and layer-to-layer variability

Multiparticulate or coated-particle system

Each active is granulated or layered separately, then coated or compressed into a tablet.

This architecture offers the highest control over release but has the greatest process burden. It can be attractive where a company wants a defensible manufacturing process, a capsule or sprinkle format, or a differentiated abuse-resistance profile.

What formulation variables control commercial performance?

The most important variables are polymer concentration, tablet porosity, compression force, granule density, active particle size, lubricant level, and coating weight gain.

Polymer loading

Increasing polymer loading typically extends release but can reduce tablet compactability and increase tablet size. Excessive polymer can produce an undesirable plateau in release or leave a swollen matrix that is difficult to swallow.

Tablet porosity

Porosity controls liquid ingress. A highly porous tablet can produce rapid hydration and early drug release. A dense tablet can slow hydration but may impair complete release of the active ingredients.

Compression force

Compression force affects hardness, friability, dissolution, and tablet ejection. A robust process should establish a design space that maintains dissolution across normal compression-force variation.

Lubrication

Over-lubrication with magnesium stearate can reduce wettability and slow dissolution. Sodium stearyl fumarate can be evaluated where less hydrophobic lubrication is needed, although cost and supplier availability must be considered.

Active particle size

Particle-size distribution affects blend uniformity, dissolution, segregation, and content uniformity. Dextromethorphan’s lower dose increases the importance of ordered mixing or granulation controls.

What excipient combinations offer the best commercial opportunity?

A practical development platform can use a high-dose guaifenesin matrix with a controlled dextromethorphan fraction.

Development platform	Core excipient concept	Commercial assessment
Cost-focused generic	Hypromellose, microcrystalline cellulose, povidone, magnesium stearate	Lowest development and manufacturing cost
Robust direct-compression product	Hypromellose, silicified microcrystalline cellulose, sodium stearyl fumarate	Good flow and scale-up potential
Bilayer differentiated product	Separate polymer systems for each active	Higher control and higher capital requirement
Premium swallowability product	Smaller tablet, dense matrix, optimized film coat	Potential retail differentiation
Moisture-resistant product	Low-moisture excipient system and high-barrier bottle	Useful for shelf-life and geographic expansion
Abuse-resistant platform	Strong matrix, high-viscosity polymer, tamper-resistant packaging	Higher technical and regulatory burden

The strongest near-term commercial approach is usually a robust single-tablet matrix supported by a narrow, well-characterized dissolution profile. Bilayer technology is more defensible but may not justify its cost in a price-sensitive private-label market unless it solves a documented release or patient-use problem.

What regulatory pathway applies to Mucus Relief ER DM?

Is Mucus Relief ER DM an FDA-approved prescription product?

The product category is generally positioned as an OTC drug. Guaifenesin and dextromethorphan are recognized OTC active ingredients for cough and cold indications under FDA monograph requirements, subject to dosage, labeling, combination, and formulation conditions.[1]

A manufacturer marketing an OTC product under the applicable monograph must comply with:

• Active-ingredient requirements
• Dosage and administration provisions
• Required warnings
• Child-resistant packaging requirements where applicable
• Current good manufacturing practice requirements
• Product quality and stability standards
• Labeling restrictions on therapeutic claims

A product that falls outside the monograph may require an FDA-approved application or another applicable regulatory pathway.

Does the product have Orange Book status?

A monograph-compliant OTC product generally does not have the same Orange Book listing structure as a prescription drug approved under an NDA or ANDA. Orange Book analysis is therefore not the primary tool for evaluating market entry for a compliant OTC Mucus Relief ER DM product.[2]

The relevant competitive barriers are usually:

• Formulation know-how
• Dissolution matching
• Manufacturing scale
• Brand recognition
• Retailer contracts
• Packaging and supply reliability
• Potential formulation or process patents
• Trade secrets

Are Paragraph IV challenges relevant?

Paragraph IV litigation is generally associated with ANDA products referencing listed prescription drugs. It is not normally the central market-entry mechanism for a monograph-compliant OTC product. A company may still encounter patent disputes involving a branded extended-release formulation, manufacturing process, tablet architecture, or delivery technology, but the legal analysis is distinct from a standard prescription-drug ANDA challenge.

What patents protect Mucus Relief ER DM?

The specific patent estate cannot be determined from the product name alone. Different suppliers may use different formulations and manufacturing processes. The relevant patent categories include:

1. Extended-release matrix compositions.
2. Bilayer tablet structures.
3. Polymer combinations controlling drug release.
4. Manufacturing methods for high-load guaifenesin tablets.
5. Coated-particle or multiparticulate systems.
6. Taste-masking and swallowability technologies.
7. Packaging systems designed to control moisture or deter misuse.
8. Combination claims covering guaifenesin and dextromethorphan.

Older branded formulations may have expired composition or formulation patents, but an expired pioneer patent does not eliminate risk from later patents covering a specific release profile, excipient ratio, coating process, or manufacturing sequence. A product-specific freedom-to-operate review should search U.S. patents, continuations, foreign counterparts, and assignment records using the exact manufacturer, NDC, active-ingredient strengths, dosage form, and formulation disclosures.

How strong is the patent estate for this product category?

The patent estate is likely moderate rather than structurally dominant.

The active ingredients are established OTC compounds with extensive prior art. This weakens broad composition claims. Patent strength can still arise from narrow technical features, such as:

• A defined dissolution profile at multiple time points
• A particular hypromellose combination
• A bilayer interface
• A particle-coating process
• Improved stability under high humidity
• Reduced tablet size at equivalent dose
• Controlled release with reduced dose dumping

The strongest claims are likely to be process- or formulation-specific. Broad claims covering guaifenesin and dextromethorphan in an extended-release tablet face substantial prior-art pressure.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can target this category through performance, supply security, and regulatory support rather than through basic commodity pricing alone.

Controlled-release polymer supply

A supplier can differentiate with:

• Multiple hypromellose viscosity grades
• Consistent substitution levels
• Low microbial and endotoxin profiles
• Narrow particle-size distributions
• Global regulatory documentation
• Lot-to-lot dissolution consistency

The value proposition is lower batch failure risk and faster scale-up.

Direct-compression excipient systems

Co-processed excipients can reduce development time by improving flow, compactability, and content uniformity. This is particularly relevant for high-dose guaifenesin tablets, where the tablet can become large or mechanically weak.

Moisture-control systems

Moisture-sensitive matrix formulations may benefit from:

• High-barrier bottles
• Desiccant systems
• Moisture-resistant film coatings
• Low-moisture excipient grades
• Blister packaging with improved barrier properties

Packaging is a commercial opportunity because a stable formulation can reduce returns, discoloration, dissolution drift, and seasonal quality complaints.

Functional film coatings

Film coatings can support:

• Improved swallowability
• Reduced taste exposure
• Product identification
• Differentiated appearance
• Protection from humidity and abrasion

The coating must not materially change the intended release profile unless the product is developed and labeled on that basis.

How does Mucus Relief ER DM compare with Mucinex DM?

Mucinex DM is the primary branded reference point for the same broad combination of guaifenesin and dextromethorphan. Mucus Relief ER DM competes through lower price, retailer placement, private-label economics, and potential formulation similarity.

Factor	Mucinex DM	Mucus Relief ER DM or private label
Brand equity	High	Usually lower
Price	Premium	Discounted
Active ingredients	Guaifenesin/dextromethorphan	Typically the same combination
Release claim	Extended release	Typically extended release
Retail access	National brand channels	Retailer and distributor dependent
Formulation transparency	Product-specific	Supplier-specific
Patent risk	Brand-related legacy and later formulation rights	Depends on supplier process and formulation
Commercial moat	Brand, distribution, consumer recognition	Cost, retailer relationships, supply

A private-label product does not need to replicate every inactive ingredient in the branded product. It must meet applicable regulatory requirements and deliver acceptable quality, stability, and dissolution performance.

What manufacturing and IP barriers affect market entry?

The principal manufacturing barriers are scale-up and dissolution reproducibility. A laboratory formulation may perform adequately while a commercial batch fails because of changes in granule density, compression speed, or polymer hydration.

Critical process parameters include:

• Blend time
• Granulation endpoint
• Drying temperature and residual moisture
• Lubrication time
• Compression force
• Turret speed
• Coating spray rate
• Coating inlet temperature
• Tablet hold time before packaging

The principal IP barrier is a formulation or process patent that claims the exact architecture needed to match a commercial reference. A design-around may use a different polymer grade, separate granulation steps, a different coating system, or an alternative tablet architecture.

What is the generic launch risk?

Generic or private-label launch risk is moderate.

Lower-risk scenario

A manufacturer uses a monograph-compliant formulation, an established polymer system, validated dissolution controls, and independent packaging. Entry can occur through retailer or distributor channels without relying on a prescription ANDA launch.

Medium-risk scenario

The manufacturer attempts to closely match a branded extended-release dissolution profile. Technical failure, formulation patent claims, and supply interruptions become more significant.

Higher-risk scenario

The product uses a bilayer or coated-particle system with a narrow dissolution window, novel excipient ratios, or a process that overlaps with an active patent family. Development time, capital expenditure, and litigation exposure increase.

What licensing deals and partnerships are relevant?

Commercial opportunities are most likely to involve:

• Contract manufacturing agreements
• Private-label retailer supply contracts
• Polymer or co-processed excipient licenses
• Film-coating technology partnerships
• Packaging and moisture-control supply agreements
• Regional distribution licenses

A formulation technology license is most valuable when it provides a validated manufacturing process, dissolution data, scale-up history, and regulatory documentation. A license covering only a broad excipient concept has less value because many alternative polymer systems are available.

What revenue exposure does the category create?

Mucus Relief ER DM is an established, price-sensitive OTC category. Revenue is exposed to:

• Seasonal respiratory demand
• Retailer inventory cycles
• Private-label price competition
• Ingredient and packaging costs
• Supply disruptions
• Consumer switching between branded and store-brand products
• Regulatory changes affecting cough-and-cold labeling

The best margin opportunity is not necessarily the lowest tablet cost. It is the lowest total cost of quality, including rejected batches, dissolution failures, packaging defects, returns, and retailer chargebacks.

Key Takeaways

• Mucus Relief ER DM is generally a 600 mg guaifenesin/30 mg dextromethorphan extended-release tablet.
• Hypromellose-based matrix technology is the most practical starting platform.
• A bilayer tablet offers greater release control but adds equipment, validation, and scale-up costs.
• The main commercial opportunity is a reliable, low-cost private-label product with consistent dissolution and strong moisture protection.
• OTC monograph compliance is generally more relevant than Orange Book listing or Paragraph IV litigation.
• Patent risk is likely concentrated in narrow formulation, process, coating, and release-profile claims.
• Excipient suppliers can create value through polymer consistency, direct-compression systems, moisture control, and regulatory support.
• Exact patent, manufacturer, and Orange Book conclusions require product-specific identification because the Mucus Relief name may be used across multiple suppliers and NDCs.

FAQs About Mucus Relief ER DM Formulation and Commercial Strategy

What is the usual strength of Mucus Relief ER DM?

The common strength is 600 mg guaifenesin and 30 mg dextromethorphan hydrobromide per extended-release tablet.

Which excipient controls the extended release?

Hypromellose is a common controlling polymer, although the exact grade, concentration, and combination with other excipients determine the dissolution profile.

Can Mucus Relief ER DM be manufactured by direct compression?

Yes. Direct compression can reduce manufacturing complexity, but high guaifenesin loading makes powder flow, content uniformity, tablet hardness, and capping control important.

Is Mucus Relief ER DM protected by a broad active-ingredient patent?

Broad active-ingredient protection is unlikely for established guaifenesin and dextromethorphan. Any remaining risk is more likely to involve a specific formulation, release profile, manufacturing process, or coating system.

What is the most attractive commercial differentiation?

The strongest opportunities are lower tablet size, improved swallowability, stable 12-hour release, moisture-resistant packaging, supply reliability, and retailer-specific private-label economics.

References

1. U.S. Food and Drug Administration. (2024). Over-the-counter monograph M012: Cough-cold, 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). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book

3. U.S. Food and Drug Administration. (2014). Guidance for industry: SUPAC-MR: Modified release solid oral dosage forms, scale-up and postapproval changes. https://www.fda.gov

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

5. International Council for Harmonisation. (2003). ICH Q8(R2): Pharmaceutical development. https://www.ich.org

6. U.S. Food and Drug Administration. (2023). Current good manufacturing practice requirements for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. https://www.ecfr.gov