List of Excipients in Branded Drug BERKLEY AND JENSEN MUCUS RELIEF DM

Generic Drugs Containing BERKLEY AND JENSEN MUCUS RELIEF DM

Company	Ingredient	NDC	Excipient
BJWC	dextromethorphan hbr, guaifenesin	68391-812	CARBOMER HOMOPOLYMER TYPE B
BJWC	dextromethorphan hbr, guaifenesin	68391-812	CELLULOSE, MICROCRYSTALLINE
BJWC	dextromethorphan hbr, guaifenesin	68391-812	COPOVIDONE K25-31

What are the Most Frequently-Used Excipients in BERKLEY AND JENSEN MUCUS RELIEF DM?

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

Berkley and Jensen Mucus Relief DM: Excipient Strategy and Commercial Opportunities

Last updated: July 31, 2026

Berkley and Jensen Mucus Relief DM is an over-the-counter extended-release combination of guaifenesin and dextromethorphan hydrobromide. Its commercial position depends less on drug-substance exclusivity than on low-cost formulation, reliable 12-hour release, tablet manufacturability, packaging, and private-label retail economics. The product is positioned against Mucinex DM and other store-brand expectorant-cough suppressant products.

The formulation opportunity is concentrated in controlled-release matrix design, tablet robustness, coating efficiency, excipient substitution, and line extensions. The product operates within the FDA OTC monograph framework, which reduces regulatory barriers but also limits opportunities to claim novel therapeutic differentiation.[1]

What is Berkley and Jensen Mucus Relief DM?

Berkley and Jensen Mucus Relief DM contains two active ingredients:

Attribute	Product information
Brand	Berkley and Jensen
Retailer	BJ’s Wholesale Club
Product type	OTC cough and cold medicine
Active ingredients	Guaifenesin and dextromethorphan hydrobromide
Typical strength	Guaifenesin 600 mg and dextromethorphan HBr 30 mg per extended-release tablet
Dosage form	Extended-release oral tablet
Primary claims	Relieves chest congestion and controls cough
Dosing profile	Generally one tablet every 12 hours, subject to the marketed label
Regulatory pathway	OTC monograph or monograph-compliant marketed product
Reference competitor	Mucinex DM extended-release tablets

Guaifenesin is an expectorant intended to loosen phlegm and thin bronchial secretions. Dextromethorphan hydrobromide is a centrally acting cough suppressant. The combination addresses two related symptoms while allowing a twice-daily dosing schedule.

The product’s commercial value is tied to the extended-release profile. A formulation that releases both actives too quickly could undermine the 12-hour claim, while excessive retardation could delay symptom relief.

What excipients are used in Berkley and Jensen Mucus Relief DM?

The product’s inactive ingredients are expected to support matrix formation, tablet compression, disintegration control, lubrication, coating, and physical stability. Exact excipient composition can vary by manufacturer, product presentation, and manufacturing revision.

Common excipient functions for this type of tablet include:

Excipient function	Typical materials	Commercial purpose
Matrix former	Hypromellose	Controls water penetration and drug diffusion
Diluent	Microcrystalline cellulose	Adds bulk and supports compression
Binder	Povidone or hypromellose	Improves granule and tablet strength
Superdisintegrant	Croscarmellose sodium or sodium starch glycolate	Controls tablet breakup and matrix erosion
Glidant	Colloidal silicon dioxide	Improves powder flow
Lubricant	Magnesium stearate or stearic acid	Reduces sticking and ejection force
Coating polymer	Hypromellose, polyethylene glycol	Improves swallowability and appearance
Opacifier or pigment	Titanium dioxide or approved alternatives	Provides color and light protection
Anti-adherent	Talc	Reduces sticking during compression and coating

The most important excipient variable is the hydrophilic matrix former. Hypromellose grade, viscosity, particle size, substitution type, and loading level can materially alter release. A small change in polymer concentration can affect the initial release phase, tablet erosion, and terminal release.

How does the excipient strategy control 12-hour release?

A conventional strategy is a hydrophilic matrix tablet in which hypromellose hydrates after ingestion. The hydrated polymer layer limits water penetration and slows diffusion of guaifenesin and dextromethorphan.

The release profile can be adjusted through:

1. Polymer viscosity. Higher-viscosity hypromellose generally increases gel strength and slows release.
2. Polymer loading. Higher loading can reduce burst release but may delay onset.
3. Drug-to-polymer ratio. The high guaifenesin dose creates a substantial solid-load challenge.
4. Tablet geometry. Thickness and surface area affect hydration and erosion.
5. Compression force. Higher compression can reduce porosity and delay water ingress.
6. Particle size. Smaller particles can improve blend uniformity but may alter wetting and dissolution.
7. Disintegrant selection. Excessive disintegrant can compromise extended release.
8. Coating weight gain. A film coat should improve handling without becoming the primary release barrier unless intentionally designed as such.

Guaifenesin is present at a much higher dose than dextromethorphan. The formulation therefore must achieve content uniformity for a relatively low-dose active while accommodating a high total drug load. Direct compression may reduce process complexity, but wet granulation can improve flow, segregation control, and tablet strength.

What excipient risks affect product performance?

The main technical risks are dose dumping, slow onset, tablet capping, sticking, inadequate hardness, and dissolution variability.

Dose dumping and alcohol sensitivity

Extended-release products require evaluation under conditions that could accelerate drug release. Alcohol-induced dose dumping can occur when ethanol disrupts polymer hydration or changes matrix permeability. A robust formulation should be evaluated across relevant alcohol concentrations and dissolution media.

Content uniformity

Dextromethorphan is a lower-dose component than guaifenesin. Segregation during blending, transfer, or hopper discharge can create assay variability. A high-functionality excipient system should support uniform distribution without requiring excessive processing.

Tablet size and swallowability

A 600 mg guaifenesin dose creates a large tablet burden. Additional excipients can make the tablet difficult to swallow, particularly for consumers with cough-related throat irritation. Increasing excipient efficiency may enable a smaller tablet or reduce coating and packaging costs.

Moisture sensitivity

Hydrophilic polymers and superdisintegrants can respond to environmental moisture. Moisture uptake may change hardness, friability, disintegration, and dissolution. Packaging selection is therefore part of the formulation strategy, not a separate commercial decision.

What formulation patents protect Mucus Relief DM?

No product-specific patent estate is generally associated with the Berkley and Jensen private-label product. The active ingredients are established OTC substances, and the combination is commercially available from multiple manufacturers.

Potential intellectual-property categories include:

• Extended-release matrix formulations
• Specific hypromellose grades or polymer ratios
• Dissolution profiles
• Bilayer or multilayer tablets
• Abuse-deterrent or taste-masked dosage forms
• Manufacturing processes
• Packaging configurations
• Brand and trade dress rights

These rights would ordinarily protect a particular formulation or manufacturing implementation rather than guaifenesin or dextromethorphan themselves. A formulation supplier seeking to commercialize a substitute should conduct a current patent search in the United States and relevant foreign markets before launch.

The absence of a known product-specific patent does not eliminate freedom-to-operate risk. Active patent families may cover release-control technologies, excipient combinations, or manufacturing processes used by branded competitors.

When does Berkley and Jensen Mucus Relief DM lose exclusivity?

Berkley and Jensen Mucus Relief DM does not have conventional NCE, five-year, or three-year FDA exclusivity. The product is an OTC private-label medicine operating in a substitutable category.

Its commercial protection comes from:

• Retailer sourcing arrangements
• Supplier qualification
• Cost position
• Packaging and shelf placement
• Brand recognition within BJ’s membership base
• Manufacturing scale
• Quality and supply continuity

The product is not protected by exclusivity comparable to a prescription drug approved under an NDA. OTC monograph compliance allows competing manufacturers to market products with the same active ingredients and therapeutic claims, provided they satisfy applicable FDA requirements.[1]

What is the Orange Book status of Berkley and Jensen Mucus Relief DM?

The product is not expected to have an Orange Book listing comparable to an NDA or ANDA prescription product. The Orange Book primarily identifies approved drug products with therapeutic-equivalence determinations and patent or exclusivity information relevant to prescription and certain approved drug applications.[2]

For an OTC monograph product, competitive analysis should focus on:

• FDA monograph conditions
• Drug Facts labeling
• Manufacturing compliance
• Product registration and listing requirements
• State and federal packaging rules
• Supplier and contract-manufacturer controls

Orange Book Paragraph IV litigation is therefore not the central entry mechanism for this product category.

Are there Paragraph IV challenges or generic litigation risks?

A conventional Paragraph IV challenge is unlikely to be relevant to the private-label product itself because the product is not principally protected by an NDA patent listing. Competition generally enters through parallel OTC monograph products rather than through an abbreviated application challenging listed patents.

Litigation risk can still arise from:

• Patent claims covering a competing extended-release formulation
• Trade dress or trademark disputes
• False advertising claims involving duration or symptom relief
• Product liability claims
• Manufacturing and contamination issues
• Contract disputes between the retailer, label owner, and supplier

Settlement agreements are not a routine feature of this product category. The commercial contest is usually managed through pricing, retailer exclusivity, sourcing, and product quality rather than patent settlements.

What are the best excipient-led commercial opportunities?

Lower-cost extended-release matrices

A supplier could develop a hypromellose-based matrix that matches the reference dissolution profile with lower polymer loading. The economic benefit would come from reduced raw-material cost, shorter blending time, improved tablet throughput, or lower tablet weight.

Direct-compression platforms

A direct-compression formulation could reduce granulation, drying, and milling steps. The platform would need strong flow, low segregation risk, acceptable tablet hardness, and consistent dissolution at commercial scale.

Smaller tablets

High-functionality fillers and improved compaction could reduce tablet size. This is commercially relevant because consumer acceptance is sensitive to swallowability, especially for twice-daily tablets taken during respiratory illness.

Alcohol-resistant release

A matrix with improved resistance to ethanol-triggered release could support a stronger quality profile and reduce a key risk associated with modified-release products. Any such claim would require appropriate testing and regulatory review.

Improved coating systems

A faster, lower-temperature aqueous coating process could reduce energy use and manufacturing time. Color and opacity changes may also support brand differentiation while avoiding unnecessary titanium dioxide exposure where the market favors alternative pigments.

Moisture-protective packaging

Blister packaging, high-barrier bottles, desiccants, and induction seals can protect dissolution performance. The commercial decision depends on the balance between packaging cost, shelf life, transportation conditions, and consumer convenience.

Pediatric and family-oriented line extensions

A liquid or chewable product could expand the franchise, but dosage-form changes introduce greater stability, palatability, preservative, dosing-device, and age-labeling requirements. A 12-hour pediatric product would require particularly careful regulatory and safety analysis.

How does Berkley and Jensen compare with Mucinex DM?

Factor	Berkley and Jensen Mucus Relief DM	Mucinex DM
Positioning	Private-label value product	National branded product
Active ingredients	Guaifenesin plus dextromethorphan HBr	Guaifenesin plus dextromethorphan HBr
Main differentiation	Retail price and BJ’s distribution	Brand recognition and national marketing
Patent leverage	Limited or product-specific rights not publicly central	Potential formulation and brand-related rights
Distribution	BJ’s stores and digital channels	Broad retail, pharmacy, and e-commerce distribution
Excipient opportunity	Cost reduction, supply substitution, quality parity	Lifecycle management and differentiated dosage forms
Regulatory basis	OTC monograph framework	OTC monograph framework or applicable approved-product pathway

The private-label product can compete effectively when its formulation performs equivalently in routine quality testing and its price remains meaningfully below the branded reference. The branded product has greater ability to monetize packaging, advertising, and consumer recognition.

Which companies are challenging the product commercially?

Competition comes from national brands, pharmacy private labels, mass-retail private labels, grocery chains, club stores, and online sellers. Relevant competitive products include:

• Mucinex DM
• CVS Health mucus-relief and cough products
• Walgreens store-brand equivalents
• Walmart Equate products
• Target Up&Up products
• Amazon Basic Care products
• Generic guaifenesin and dextromethorphan combinations

The competitive threat is primarily substitution at the shelf or search-results level. A rival does not need to invalidate a patent to take share. It can offer a lower price, larger count, improved packaging, or more favorable retailer economics.

What is the revenue exposure for BJ’s and suppliers?

BJ’s does not separately disclose revenue, gross margin, or unit volume for Berkley and Jensen Mucus Relief DM in its public financial reporting. Product-level exposure therefore depends on internal sales data, retailer replenishment, seasonal demand, and supplier contracts.[3]

The category has seasonal concentration, with demand generally increasing during respiratory-illness periods. Revenue and inventory planning should account for:

• Winter demand peaks
• Promotional calendars
• Retailer club traffic
• Private-label penetration
• Active-ingredient and excipient availability
• Contract-manufacturing capacity
• Product recalls or supply interruptions

For an excipient supplier, the commercial opportunity is more likely to arise from multi-SKU platform adoption than from one product. A release-control system that supports guaifenesin/dextromethorphan tablets could also be adapted to other OTC modified-release combinations.

What manufacturing and IP barriers exist?

Manufacturing barriers are moderate rather than extreme. The active ingredients are established, but commercial success requires reliable scale-up and dissolution control.

Key barriers include:

• Uniform blending of a low-dose suppressant with a high-dose expectorant
• Control of tablet weight and hardness
• Reproducible extended-release dissolution
• Validation of alcohol robustness
• Stability under humidity and temperature stress
• Coating throughput
• Supplier qualification for functional polymers
• Compliance with current good manufacturing practice
• Control of analytical methods and reference standards

The principal IP barrier is formulation-specific. A supplier should compare its proposed polymer system, dissolution profile, granulation method, and coating process against active patent families before commercialization.

What is the outlook for generic launch and product reformulation?

Generic and private-label launch risk is high because the active ingredients are old, widely available, and familiar to manufacturers. The most defensible commercial position is a low-cost product with reliable quality and strong retailer execution.

Reformulation opportunities are strongest where they produce measurable benefits:

• Smaller tablet dimensions
• Faster initial relief with sustained later release
• Better dissolution consistency
• Reduced tablet defects
• Lower coating cost
• Improved moisture stability
• Less dependence on a single polymer supplier
• More efficient packaging

A reformulation should be assessed against the current product’s dissolution, assay, impurities, stability, appearance, hardness, friability, and consumer handling characteristics. Changes to inactive ingredients can affect regulatory submissions, labeling, technical agreements, and post-market quality systems.

Key Takeaways

• Berkley and Jensen Mucus Relief DM is an OTC extended-release guaifenesin/dextromethorphan product sold under BJ’s private label.
• Its core formulation opportunity lies in hydrophilic matrix control, especially hypromellose selection and loading.
• The product has limited conventional patent or exclusivity protection.
• Orange Book and Paragraph IV analysis are less important than OTC monograph compliance, formulation freedom to operate, and supplier economics.
• The strongest excipient opportunities are smaller tablets, lower-cost matrices, direct compression, alcohol-resistant release, improved coating, and moisture-protective packaging.
• Product-level revenue is not separately disclosed by BJ’s.
• Commercial competition is driven by price, availability, packaging, retailer placement, and perceived equivalence to Mucinex DM.

FAQs

Can a new manufacturer market a guaifenesin and dextromethorphan product without a license from BJ’s?

Yes. A manufacturer can develop a competing OTC product if it satisfies applicable FDA requirements, uses compliant labeling, meets quality standards, and avoids infringement of third-party patent, trademark, or trade dress rights.

Is hypromellose necessary for an extended-release Mucus Relief DM tablet?

No. Hypromellose is a common matrix former, but other polymers and release-control systems may be used if the finished product meets required performance, stability, safety, and quality specifications.

Can excipient substitution change the regulatory status of the product?

It can affect regulatory obligations and product comparability. A change in inactive ingredients may require updated specifications, stability data, labeling review, manufacturing validation, or other regulatory documentation, depending on the product pathway and the nature of the change.

Would an orally disintegrating tablet be a strong line extension?

It could improve convenience, but an orally disintegrating dosage form conflicts with the release-control requirements of a 12-hour product unless the formulation uses a separate controlled-release technology. Taste, dose loading, tablet size, and stability would be major development constraints.

Does a private-label OTC product need an Orange Book patent listing?

No. OTC monograph products generally do not depend on Orange Book patent listings for market protection. Their commercial position is based on monograph compliance, manufacturing capability, branding, distribution, and cost.

References

1. U.S. Food and Drug Administration. (2023). 21 CFR Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-341

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/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

3. BJ’s Wholesale Club Holdings, Inc. (2024). Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. U.S. Securities and Exchange Commission. https://www.sec.gov/edgar/browse/?CIK=1534992