List of Excipients in Branded Drug DG HEALTH IBUPROFEN PM

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Generic Drugs Containing DG HEALTH IBUPROFEN PM

Company	Ingredient	NDC	Excipient
Dolgencorp Inc	diphenhydramine citrate and ibuprofen	55910-050	CELLULOSE, MICROCRYSTALLINE
Dolgencorp Inc	diphenhydramine citrate and ibuprofen	55910-050	CROSCARMELLOSE SODIUM
Dolgencorp Inc	diphenhydramine citrate and ibuprofen	55910-050	FD&C BLUE NO. 2
Dolgencorp Inc	diphenhydramine citrate and ibuprofen	55910-050	FERROSOFERRIC OXIDE

What are the Most Frequently-Used Excipients in DG HEALTH IBUPROFEN PM?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 2
1	FERROSOFERRIC OXIDE

DG Health Ibuprofen PM Excipient Strategy and Commercial Opportunities

Last updated: November 1, 2026

DG Health Ibuprofen PM is an OTC nighttime analgesic combining ibuprofen 200 mg with diphenhydramine citrate 38 mg, equivalent to diphenhydramine hydrochloride 25 mg. Its commercial position is based on low-cost private-label distribution, dual symptom relief, and mature active ingredients rather than on proprietary drug technology. The largest opportunities are dosage-form upgrades, improved swallowability, packaging differentiation, supply-chain control, and adjacent sleep and pain products.

The product is generally regulated under FDA OTC monograph requirements for internal analgesic, antipyretic, and nighttime sleep-aid products. Its active ingredients have extensive generic competition and no meaningful composition-of-matter patent barrier. Commercial value therefore depends on manufacturing economics, product quality, shelf placement, retailer strategy, and consumer adherence.

What is DG Health Ibuprofen PM?

DG Health Ibuprofen PM is a retailer-branded nighttime pain-relief product sold through Dollar General channels. The standard product profile is:

Attribute	Product profile
Brand	DG Health
Product type	OTC nighttime analgesic and sleep aid
Primary active	Ibuprofen, 200 mg
Secondary active	Diphenhydramine citrate, 38 mg, equivalent to diphenhydramine HCl 25 mg
Typical indication	Occasional sleeplessness associated with minor aches and pains
Dosage form	Oral solid dosage form, generally a caplet or tablet depending on SKU
Regulatory pathway	FDA OTC monograph or monograph-aligned OTC labeling
Prescription requirement	None
Likely commercial owner	Dollar General private-label brand, manufactured by a contracted OTC manufacturer
Core competitive set	Advil PM, Motrin PM, store-brand ibuprofen PM, acetaminophen PM products

The product’s value proposition is a single dose for pain relief and temporary nighttime sleep assistance. The formula is pharmacologically mature, with the principal commercial risks involving side effects, dosing confusion, packaging, and manufacturing consistency.

How does the formulation work?

Ibuprofen is a nonsteroidal anti-inflammatory drug that reduces prostaglandin-mediated pain, inflammation, and fever. Diphenhydramine is a first-generation antihistamine with sedating properties. The combination targets consumers who have minor pain that interferes with sleep.

The formulation must preserve both active ingredients during shelf life while allowing rapid tablet disintegration and acceptable dissolution. Excessively aggressive coating or high lubricant levels can delay dissolution. Excessive tablet hardness can also affect disintegration and consumer experience.

What excipients are likely used in DG Health Ibuprofen PM?

The exact inactive-ingredient list depends on the specific NDC, manufacturer, dosage form, and package size. Retailer-branded OTC products can change contract manufacturers without changing the consumer-facing brand. A typical ibuprofen-diphenhydramine caplet may contain excipients from the following functional categories:

Excipient category	Common examples	Commercial function
Diluent or filler	Microcrystalline cellulose, lactose, dibasic calcium phosphate	Controls tablet weight, density, and manufacturability
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Provides granule and tablet strength
Disintegrant	Croscarmellose sodium, sodium starch glycolate	Promotes tablet breakup after ingestion
Glidant	Colloidal silicon dioxide	Improves powder flow and die filling
Lubricant	Magnesium stearate, stearic acid	Reduces sticking and ejection force
Coating polymer	Hypromellose, polyvinyl alcohol	Supports appearance, taste masking, and handling
Plasticizer	Polyethylene glycol	Improves coating flexibility
Opacifier or pigment	Titanium dioxide, iron oxides	Controls color and opacity
Surfactant	Sodium lauryl sulfate or equivalent	Can improve wetting and dissolution
Processing aid	Talc or related materials	Supports coating and manufacturing performance

This table describes a formulation strategy, not a confirmed complete label for every DG Health SKU. The controlling source for a specific product is the current package label and its corresponding FDA listing.

Which excipients matter most for ibuprofen PM?

The highest-value excipient decisions concern dissolution, tablet hardness, coating, and sensory properties.

Ibuprofen has limited water solubility. Particle-size control, wetting agents, granulation conditions, and disintegrant selection can affect dissolution performance. Diphenhydramine salts are more water soluble, so the formulation must avoid creating an imbalance in release behavior between the two actives.

Microcrystalline cellulose and a superdisintegrant can provide a cost-effective direct-compression platform. Povidone or pregelatinized starch may be useful where wet granulation is needed to improve blend uniformity. Magnesium stearate should be controlled because excessive lubrication can reduce tablet wettability and slow dissolution.

A film coat can reduce the bitter or chemical taste associated with both actives and improve product appearance. The coat should remain thin enough to avoid unnecessary increases in tablet size. For nighttime products, a smooth, easy-to-swallow caplet can have stronger commercial value than a heavily colored or oversized tablet.

What excipient strategy best supports a private-label ibuprofen PM product?

A practical formulation strategy has four objectives: low cost, robust manufacturing, compliant dissolution, and consumer acceptability.

Cost-focused core formulation

The lowest-cost platform is usually a conventional immediate-release compressed tablet or caplet using widely available excipients. Microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate are established materials with broad supplier availability.

The formulation should avoid unnecessary specialty excipients, complex multilayer technology, and expensive coating systems unless they create a measurable commercial benefit. Private-label economics favor repeatable high-volume production and low changeover complexity.

Dissolution-focused formulation

Ibuprofen’s dissolution profile can be improved through:

• Smaller ibuprofen particle size
• More effective wetting
• Controlled granulation
• Higher-performing disintegrants
• Reduced hydrophobic lubricant exposure
• Optimized coating weight
• Consistent tablet porosity

The target is not simply rapid tablet breakup. The product must achieve reproducible dissolution without compromising tablet strength, friability, stability, or production yield.

Consumer-focused formulation

A smaller caplet, smoother coating, reduced odor, and easier swallowing can distinguish a store-brand product from a low-cost generic. These changes may not create patent protection, but they can improve retailer conversion and reduce complaints.

Potential consumer-facing improvements include:

• Smaller tablet dimensions
• Film coating with improved gloss and reduced tack
• Reduced chalkiness
• Color coding for nighttime use
• Scored or easy-open packaging where appropriate
• Unit-dose blister packaging for travel and adherence

Color and packaging claims require careful review because the product already contains a sedating ingredient. Visual differentiation must not encourage accidental daytime use or dosing by children.

What FDA regulatory status applies to ibuprofen PM?

Ibuprofen is an FDA-recognized OTC analgesic active ingredient when used under applicable monograph conditions. Diphenhydramine is recognized as an OTC nighttime sleep-aid ingredient under the relevant FDA framework. The combination must comply with applicable active-ingredient, dosage, labeling, warning, and use requirements.

The principal regulatory controls include:

• Active-ingredient identity and strength
• Directions and maximum daily use
• Warnings for stomach bleeding, cardiovascular risk, allergic reactions, and sedative effects
• Contraindications and cautions involving pregnancy, alcohol, sedatives, and other NSAIDs
• Child-resistant packaging requirements where applicable
• Drug Facts labeling
• Current good manufacturing practice requirements
• Stability, identity, strength, quality, and purity controls

The FDA’s final OTC monograph system under the CARES Act changed the procedural framework for certain nonprescription products. Manufacturers must assess whether the specific product is covered by an applicable monograph order, requires an approved application, or falls within another recognized regulatory pathway.[1]

What is the Orange Book status of DG Health Ibuprofen PM?

A retailer-branded OTC ibuprofen PM product generally is not an Orange Book-listed prescription drug. The Orange Book primarily identifies approved prescription drug products and their therapeutic-equivalence information. An OTC monograph product may not have an Orange Book entry comparable to a prescription NDA or ANDA product.[2]

The absence of an Orange Book listing does not eliminate regulatory obligations. It means that standard Paragraph IV certification analysis is generally not the principal entry mechanism for this product.

When does DG Health Ibuprofen PM lose exclusivity?

DG Health Ibuprofen PM does not have meaningful conventional drug exclusivity based on the active ingredients. Ibuprofen was introduced decades ago, and diphenhydramine is also a mature OTC active ingredient. Any brand-specific exclusivity is commercial rather than statutory.

Exclusivity type	Relevance to DG Health Ibuprofen PM
New chemical entity exclusivity	Not applicable
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No apparent product-specific basis
New OTC drug exclusivity	Not the primary commercial protection
Composition-of-matter patent	Expired or commercially irrelevant
Formulation patent	Possible only for a separately developed formulation
Trademark protection	Brand-level protection may apply
Retailer exclusivity	Contractual and distribution-based
Manufacturing know-how	Potentially important but generally non-public

The product can be challenged by competing store brands without waiting for patent expiry. Commercial barriers are shelf access, retailer procurement, approved manufacturing capacity, quality history, and cost.

Are Paragraph IV challenges relevant to ibuprofen PM?

Paragraph IV challenges are usually not the central risk for a mature OTC monograph combination. A generic applicant uses Paragraph IV certification in the ANDA system when an Orange Book-listed patent is asserted to cover the reference product. A retailer-branded OTC monograph product typically does not create that same patent-certification pathway.

Patent litigation could still arise if a manufacturer develops a proprietary dosage form, delivery system, or formulation that is separately protected. Examples could include:

• A liquid-filled softgel architecture
• A novel immediate-release coating
• A modified-release product
• A dosage form with improved taste masking
• A stability-enhanced combination
• A manufacturing process with patentable parameters

For the standard tablet or caplet, patent-based entry risk is low because the active ingredients, indication, and basic dosage form are old.

What formulation patents could protect an ibuprofen PM product?

Potential patent protection would have to come from technical differentiation rather than the basic active combination. Relevant claim categories include:

Patent category	Potential subject matter	Practical strength
Composition patent	Specific excipient ratios or particle-size distribution	Moderate if technically supported
Dosage-form patent	Softgel, orally disintegrating tablet, chewable, or multilayer tablet	Moderate to strong depending on claims
Dissolution patent	Release profile or improved ibuprofen dissolution	Moderate
Manufacturing patent	Granulation, coating, drying, or compression process	Moderate
Stability patent	Reduced degradation or improved moisture protection	Moderate
Packaging patent	Child-resistant or unit-dose delivery system	Usually narrow
Method-of-use patent	New clinical use or dosing schedule	Low relevance for standard OTC labeling

A strong formulation patent must claim a product that competitors cannot easily reproduce with substituted excipients or ordinary process adjustments. Narrow claims to a single common excipient are vulnerable to design-around strategies.

How strong is the patent estate for DG Health Ibuprofen PM?

The product-specific patent estate appears weak from a conventional pharmaceutical perspective. The core active ingredients and standard nighttime combination are mature. The strongest potential protections would be private-label manufacturing know-how, supplier specifications, process controls, packaging design, and retailer contracts.

Patent strength should be assessed separately from commercial defensibility:

Protection layer	Likely strength
Active ingredients	Very weak
Standard tablet formulation	Weak
Brand trademark	Moderate within retail channels
Retail distribution access	Moderate to strong
Contract manufacturing relationship	Moderate
Specialized softgel or delivery system	Potentially strong
Quality and supply reliability	Commercially important
Consumer recognition	Moderate for established retailer brands

What commercial opportunities exist for DG Health Ibuprofen PM?

The main commercial opportunities are product extension and margin improvement rather than patent-led exclusivity.

Softgel and liquid-filled capsule extension

A liquid-filled softgel can offer smooth swallowing and fast disintegration. It also provides a visible dosage-form distinction from standard caplets. The tradeoffs are higher manufacturing cost, greater equipment requirements, gelatin or vegetarian-shell considerations, and increased sensitivity to leakage and stability controls.

A softgel version could compete more directly with branded ibuprofen PM products while retaining a private-label price advantage.

Lower-pill-burden formats

Potential extensions include higher-strength adult products where legally permitted, although any strength change requires careful review of monograph conditions and labeling. A two-active caplet with optimized dose concentration may reduce pill burden, but the sedating diphenhydramine component limits how aggressively the product can be reformulated.

Packaging and adherence products

Unit-dose blister packs can support travel, reduce loose-tablet handling, and make nighttime dosing easier to identify. Bottles remain less expensive and better suited to high-volume retail. A dual-format strategy could allocate bottles to value shoppers and blisters to convenience-oriented consumers.

Packaging should separate the product visually from daytime ibuprofen to reduce accidental duplicate dosing. Warnings about concurrent NSAID use and sedative effects should remain prominent.

Adjacent private-label products

DG Health could extend the platform into:

• Ibuprofen daytime pain relief
• Acetaminophen nighttime products
• Diphenhydramine sleep-aid products
• Topical analgesics
• Multi-symptom cold and flu products
• Pediatric pain products with separate age-appropriate formulations
• Travel-size nighttime pain products

Each extension creates label, ingredient, and supply-chain complexity. The most efficient strategy is to reuse qualified suppliers and packaging components while avoiding unnecessary active-ingredient overlap that could confuse consumers.

How does DG Health Ibuprofen PM compare with Advil PM?

Attribute	DG Health Ibuprofen PM	Advil PM
Active combination	Ibuprofen plus diphenhydramine	Ibuprofen plus diphenhydramine
Core therapeutic purpose	Nighttime pain relief	Nighttime pain relief
Brand position	Retailer private label	National brand
Price strategy	Value-oriented	Premium or branded
Patent advantage	Limited	Limited for mature actives
Differentiation	Retail access, price, pack size	Brand recognition, marketing, dosage-form breadth
Formulation opportunity	Softgel, caplet, packaging	Brand extensions and dosage-form innovation
Primary competitive barrier	Shelf placement and sourcing	Consumer loyalty and marketing

The active-ingredient parity makes price and availability central. A DG Health product can capture share if it matches branded products on tablet quality, packaging clarity, and perceived reliability.

What generic launch risks exist?

Generic and store-brand launch risk is high in the sense that entry is easy. A competitor does not need to overcome a meaningful active-ingredient patent estate. The relevant launch barriers are:

1. FDA-compliant formulation and labeling.
2. Qualified API and excipient supply.
3. Manufacturing capacity.
4. Dissolution and stability performance.
5. Retailer approval.
6. Packaging and artwork execution.
7. Product-liability controls.
8. Competitive wholesale pricing.

The most material operational risk is not patent litigation. It is a quality event involving incorrect strength, blend uniformity, tablet failure, dissolution failure, contamination, or packaging confusion.

Which companies are challenging the market position?

The competitive field includes national brands such as Advil PM and Motrin PM, large generic manufacturers, contract OTC manufacturers, and retailer brands sold by major pharmacy, mass-market, and warehouse retailers. Exact manufacturer identity can vary by SKU and time because private-label products are frequently sourced through contract manufacturing arrangements.

Competition is strongest in:

• Standard ibuprofen PM caplets
• Liquid-filled softgels
• Acetaminophen-based nighttime products
• Standalone sleep aids
• Low-price store-brand bottles
• Small travel packs

A retailer can improve its position by maintaining two qualified manufacturers, securing dual-source APIs, and using common excipient platforms across multiple OTC products.

What licensing deals and manufacturing IP matter?

Licensing is unlikely to be necessary for the basic ibuprofen-diphenhydramine combination. It becomes relevant when a company adopts:

• Proprietary softgel technology
• Orally disintegrating delivery
• Taste-masking technology
• Novel coating systems
• Specialized high-speed manufacturing equipment
• Packaging technology
• Proprietary particle engineering

The most practical deal structure is often a contract manufacturing or technology-transfer agreement rather than a conventional pharmaceutical license. Key terms include minimum volumes, quality responsibilities, change-control rights, audit access, regulatory support, recall allocation, and ownership of improvements.

What is the revenue exposure for DG Health Ibuprofen PM?

Product-specific revenue is not generally disclosed because DG Health is a private-label retail brand and sales are embedded in Dollar General’s broader health and beauty category. Revenue exposure should be modeled using:

• Unit sales by store and channel
• Average retail price
• Wholesale transfer price
• Gross margin after manufacturing and logistics
• Promotional discounting
• Seasonal demand
• Product returns and recalls
• Share of nighttime analgesic sales
• Substitution with acetaminophen PM products

The category is typically price sensitive. Small improvements in manufacturing yield, bottle count, packaging cost, or freight can have a direct effect on gross margin. A formulation that adds costly excipients without improving consumer conversion is unlikely to create value.

Key Takeaways

• DG Health Ibuprofen PM is a mature OTC combination of ibuprofen and diphenhydramine.
• The standard product has little meaningful active-ingredient patent protection.
• Paragraph IV risk is generally limited because OTC monograph products are not typically managed like Orange Book-listed prescription products.
• Excipients should be selected for dissolution, blend uniformity, tablet strength, coating performance, cost, and supply reliability.
• Microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and film-coating polymers are likely components of a conventional platform, but the exact label depends on the SKU and manufacturer.
• The strongest commercial opportunities are softgels, smaller caplets, improved coating, unit-dose packaging, and adjacent private-label products.
• The primary competitive barriers are retailer distribution, manufacturing quality, sourcing, price, and shelf placement.
• Any formulation patent would need a credible technical distinction that competitors cannot easily design around.
• Product-specific revenue is not publicly isolated, so commercial exposure requires SKU-level retail and margin data.

FAQs

Is DG Health Ibuprofen PM the same as Advil PM?

The products generally use the same active-ingredient combination, but they may differ in excipients, dosage form, tablet dimensions, packaging, manufacturing site, and price.

Can ibuprofen PM be protected by a new patent?

A new patent could potentially cover a novel dosage form, release profile, manufacturing process, stability improvement, or packaging system. The basic ibuprofen-diphenhydramine combination is not a strong patent target because it is longstanding.

Does DG Health Ibuprofen PM have an Orange Book patent?

A standard retailer-branded OTC product generally is not expected to have an Orange Book patent listing comparable to an approved prescription NDA or ANDA product.

Which excipient can improve ibuprofen dissolution?

Wetting agents, optimized particle size, effective superdisintegrants, controlled granulation, and reduced hydrophobic lubrication can improve dissolution. The effect must be confirmed through comparative formulation and dissolution testing.

Is a softgel version commercially attractive?

A softgel can improve swallowability and create product differentiation, but it requires higher manufacturing investment and tighter control of leakage, shell integrity, stability, and supply cost.

References

1. U.S. Food and Drug Administration. (2024). Over-the-counter monograph drugs. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/over-counter-otc-monograph-drugs

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

3. U.S. Food and Drug Administration. (2024). Drug facts labeling for nonprescription drugs. https://www.fda.gov/drugs/marketing-and-communications/over-counter-otc-drug-facts-label

4. U.S. Food and Drug Administration. (2024). Current good manufacturing practice for finished pharmaceuticals. 21 C.F.R. Parts 210-211.

5. U.S. Food and Drug Administration. (2024). DailyMed: Current labeling for prescription and nonprescription drug products. https://dailymed.nlm.nih.gov/dailymed/