List of Excipients in Branded Drug SIGNATURE CARE IBUPROFEN PM

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Generic Drugs Containing SIGNATURE CARE IBUPROFEN PM

Company	Ingredient	NDC	Excipient
Safeway	diphenhydramine citrate, ibuprofen	21130-030	CELLULOSE, MICROCRYSTALLINE
Safeway	diphenhydramine citrate, ibuprofen	21130-030	CROSCARMELLOSE SODIUM
Safeway	diphenhydramine citrate, ibuprofen	21130-030	GLYCERYL DIBEHENATE
Safeway	diphenhydramine citrate, ibuprofen	21130-030	HYDROXYPROPYL CELLULOSE
Safeway	diphenhydramine citrate, ibuprofen	21130-030	LACTOSE MONOHYDRATE
Safeway	diphenhydramine citrate, ibuprofen	21130-030	MAGNESIUM STEARATE
Safeway	diphenhydramine citrate, ibuprofen	21130-030	POLYETHYLENE GLYCOL

What are the Most Frequently-Used Excipients in SIGNATURE CARE IBUPROFEN PM?

# Of NDCs	Excipient
2	CELLULOSE, MICROCRYSTALLINE
2	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 2 ALUMINUM LAKE
1	FERROSOFERRIC OXIDE
2	GLYCERYL DIBEHENATE
2	HYDROXYPROPYL CELLULOSE
2	LACTOSE MONOHYDRATE

SIGNATURE CARE IBUPROFEN PM: Excipient Strategy, OTC Exclusivity, Patent Risk, and Commercial Opportunities

Last updated: September 25, 2026

Signature Care Ibuprofen PM is an over-the-counter combination analgesic and nighttime sleep-aid product. Its commercial value is driven primarily by low-cost formulation, private-label retail distribution, packaging, and supply reliability rather than patent exclusivity. The typical formulation combines ibuprofen 200 mg with diphenhydramine citrate 38 mg, equivalent to diphenhydramine hydrochloride 25 mg, per caplet or tablet. The product is generally positioned as a store-brand alternative to Advil PM and Motrin PM.

The strongest commercial opportunities are cost reduction, improved swallowability, liquid or softgel delivery, differentiated packaging, and retailer-specific product extensions. The main regulatory constraint is compliance with the FDA’s OTC monograph requirements for internal analgesic and nighttime sleep-aid active ingredients.

What is Signature Care Ibuprofen PM?

Signature Care is a private-label consumer-health brand associated with Albertsons Companies, including Safeway and related retail banners. Signature Care Ibuprofen PM is marketed for the temporary relief of minor aches and pains with nighttime sleeplessness associated with those symptoms.

A typical product label contains:

Attribute	Typical product profile
Brand	Signature Care
Product type	OTC combination analgesic and nighttime sleep aid
Active ingredient 1	Ibuprofen 200 mg
Active ingredient 2	Diphenhydramine citrate 38 mg
Equivalent sleep-aid dose	Diphenhydramine hydrochloride 25 mg
Common dosage form	Film-coated tablet or caplet
Primary use	Temporary relief of minor aches and pains with occasional sleeplessness
Reference products	Advil PM, Motrin PM
Regulatory pathway	OTC monograph or applicable OTC final order framework
Prescription requirement	None
Patent dependency	None for the core marketed combination

Exact inactive ingredients, tablet dimensions, imprint, NDC, manufacturing site, and package count depend on the specific product presentation and supplier.

What excipients are likely used in Signature Care Ibuprofen PM?

The excipient system for an ibuprofen/diphenhydramine tablet normally supports powder flow, compression, coating, dissolution, stability, and consumer acceptability. Private-label manufacturers often use established, low-cost excipient platforms rather than proprietary ingredients.

A representative excipient architecture may include:

Functional role	Common excipient classes	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, calcium phosphate	Controls tablet weight and compressibility
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, sodium starch glycolate, crospovidone	Promotes tablet breakup and dissolution
Lubricant	Magnesium stearate, stearic acid	Reduces sticking and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow
Film former	Hypromellose, polyvinyl alcohol	Protects the tablet and improves appearance
Plasticizer	Polyethylene glycol, propylene glycol	Improves coating flexibility
Opacifier	Titanium dioxide or alternative approved opacifiers	Controls color and opacity
Colorant	FDA-permitted lake or soluble dyes	Supports product identification
Taste and odor control	Film coating, flavor masking, low-moisture packaging	Reduces bitterness and odor perception

Ibuprofen is poorly water-soluble. The formulation therefore has to balance hydrophobic drug behavior against rapid disintegration and dissolution. Diphenhydramine citrate is more water-soluble but can contribute to taste and odor issues. A standard immediate-release tablet does not require a complex delivery system, but the excipient blend must deliver consistent dissolution across commercial batches.

Which excipient attributes matter most?

The main critical material attributes are:

1. Flowability: Ibuprofen can create segregation and feeding problems when combined with lighter excipients.
2. Compressibility: The formulation must produce robust tablets without excessive force.
3. Disintegration: Excessive hydrophobic lubricant can slow tablet breakup.
4. Dissolution: The excipient matrix must support release of ibuprofen despite its low aqueous solubility.
5. Moisture control: Water can affect tablet hardness, coating performance, and stability.
6. Coating integrity: The coating must resist abrasion while remaining compatible with high-speed packaging.
7. Color uniformity: Retail products depend on consistent appearance across lots and suppliers.

What is the best excipient strategy for a private-label ibuprofen PM product?

The most economical strategy is an immediate-release, directly compressed or conventionally granulated tablet using widely available compendial excipients. A practical platform would use microcrystalline cellulose or dibasic calcium phosphate as the primary filler, crospovidone or croscarmellose sodium as the disintegrant, magnesium stearate at a controlled concentration, and a thin hypromellose-based film coat.

The excipient strategy should prioritize:

• USP-NF or otherwise qualified compendial materials.
• Dual sourcing for high-volume excipients.
• Low variability in particle size and moisture.
• Compatibility with existing contract manufacturing equipment.
• Short blending and compression cycles.
• Minimal dependence on proprietary excipient technology.
• A formulation that can transfer between manufacturers without major redevelopment.

A high-risk strategy would use a novel solubilizer, lipid system, taste-masking platform, or modified-release excipient without a clear consumer or manufacturing benefit. Those technologies can increase regulatory documentation, supplier concentration, and cost without creating a meaningful advantage in a low-price OTC category.

Should the product use direct compression or wet granulation?

Direct compression offers lower processing cost and fewer manufacturing steps. It is attractive if the active ingredients and excipients have compatible flow and compression characteristics.

Wet granulation can improve content uniformity, flow, and tablet strength, but it increases processing time, equipment requirements, and moisture exposure. It may be preferable when the active ingredients segregate or produce weak tablets during direct compression.

For a high-volume retailer product, the preferred decision rule is practical: use direct compression if dissolution, content uniformity, and tablet robustness remain within specification; use granulation only when it solves a measurable manufacturing problem.

What FDA regulatory status applies to Signature Care Ibuprofen PM?

Ibuprofen and diphenhydramine are established OTC active ingredients with monograph-based regulatory pathways. FDA regulations identify ibuprofen as an internal analgesic and diphenhydramine as a nighttime sleep-aid ingredient under applicable OTC frameworks. The product must comply with labeling, dosage, warning, indication, and testing requirements under the relevant FDA rules and final orders. [1-3]

The commercial product does not require a new drug application solely because it combines two established OTC ingredients. The manufacturer remains responsible for current good manufacturing practice, quality control, stability, adverse-event reporting, labeling compliance, and any applicable monograph conditions.

Key labeling controls include:

• Maximum daily ibuprofen exposure.
• Warnings concerning stomach bleeding, cardiovascular risk, and allergic reactions.
• Sedation warnings for diphenhydramine.
• Warnings against use with other diphenhydramine-containing products.
• Warnings against use with other NSAIDs.
• Age restrictions and pediatric dosing.
• Directions limiting continuous use for sleeplessness or pain without medical advice.

FDA’s OTC Drug Facts label rules require the active ingredients, purposes, uses, warnings, directions, and inactive ingredients to appear in a standardized format. [4]

What patents protect Signature Care Ibuprofen PM?

No core patent is needed to commercialize the conventional ibuprofen 200 mg and diphenhydramine citrate 38 mg combination. The active ingredients are long-established, and the standard immediate-release combination is not dependent on a current composition-of-matter patent.

Potentially relevant intellectual-property categories include:

IP category	Relevance to Signature Care
Active-ingredient patents	No practical relevance for conventional ibuprofen or diphenhydramine
Combination patents	Possible historical relevance, but unlikely to block a standard private-label product
Formulation patents	Could matter for softgels, rapid-release systems, taste masking, or modified release
Manufacturing patents	Usually avoidable through alternative process conditions
Trademark rights	Signature Care and retailer branding are commercially relevant
Packaging rights	Design, trade dress, and child-resistant packaging may create limited barriers
Regulatory exclusivity	No meaningful exclusivity for a conventional monograph product

The key distinction is between a conventional product and a differentiated delivery system. A new softgel, liquid-filled capsule, solubilized ibuprofen formulation, or modified-release product could create patentable formulation claims. The ordinary tablet does not normally have comparable protection.

When does Signature Care Ibuprofen PM lose exclusivity?

Signature Care Ibuprofen PM has no meaningful branded-drug exclusivity period. Its commercial protection comes from retailer control, shelf placement, pricing, supplier qualification, packaging, and manufacturing scale.

Generic or private-label competition can enter without waiting for expiration of a product patent if the competing product complies with the applicable OTC regulatory requirements. A competing manufacturer can market an equivalent combination under its own brand or as another store brand, subject to FDA requirements.

There is no typical Paragraph IV event for the conventional product because Paragraph IV litigation is primarily associated with abbreviated new drug applications referencing patents listed for an approved prescription or certain non-monograph drug products. The absence of a meaningful Orange Book patent listing removes the principal basis for a conventional Paragraph IV challenge.

What is the Orange Book status of Signature Care Ibuprofen PM?

Signature Care Ibuprofen PM is not generally an Orange Book-driven product. The FDA Orange Book primarily identifies approved prescription drug products and certain approved nonprescription products. A standard monograph-compliant private-label ibuprofen/diphenhydramine product does not depend on an Orange Book patent listing for market access.

A product-specific Orange Book assessment would require the exact NDC, manufacturer, approval pathway, and regulatory filing. The commercial risk analysis should therefore focus on OTC monograph compliance, product quality, and retailer contracts rather than listed patents.

What formulation patents could create commercial opportunities?

The most promising patent opportunities are not for the basic active combination. They are for delivery, tolerability, and manufacturing improvements.

Softgel and liquid-filled capsule systems

A softgel can improve swallowability and support rapid dispersion of ibuprofen. A liquid vehicle may improve wetting, but the formulation must address drug solubility, capsule-shell compatibility, fill viscosity, leakage, and stability.

Potential claim areas include:

• Solubilized or partially solubilized ibuprofen.
• Specific lipid or cosolvent systems.
• Capsule-shell compositions.
• Reduced sedimentation.
• Stability over commercial shelf life.
• Manufacturing methods for high-speed encapsulation.

Rapid-disintegration tablets

A fast-disintegrating caplet can support consumer claims related to ease of use and rapid release, subject to substantiation and labeling restrictions. Patent protection could focus on excipient ratios, granule structure, compression force, or dissolution performance.

Taste-masked or smaller tablets

Diphenhydramine can produce an unpleasant taste. Smaller tablets, multilayer structures, and film-coating systems may support patient acceptability. These improvements are commercially relevant for consumers who have difficulty swallowing standard caplets.

Lower-sedation positioning

A formulation cannot change diphenhydramine’s pharmacology through excipients alone. Marketing claims suggesting reduced next-day drowsiness would require clinical substantiation and careful FDA review. An excipient strategy should not be built around unsupported sedation claims.

How does Signature Care compare with Advil PM and Motrin PM?

Factor	Signature Care Ibuprofen PM	Advil PM	Motrin PM
Ownership model	Private label	Branded product	Branded product
Typical actives	Ibuprofen plus diphenhydramine	Ibuprofen plus diphenhydramine	Ibuprofen plus diphenhydramine
Core clinical use	Pain relief with nighttime sleeplessness	Same	Same
Primary advantage	Lower retail price and retailer control	Brand recognition	Brand recognition
Patent dependence	Low	Low for conventional product	Low for conventional product
Formulation differentiation	Supplier- and SKU-dependent	May include branded delivery variants	May include branded delivery variants
Distribution	Albertsons-related retail channels and online sales	Broad national retail distribution	Broad national retail distribution
Main competitive risk	Other private labels and retailer switching	Private-label substitution	Private-label substitution

Private-label products usually compete through price and availability. Branded products can justify higher prices through advertising, consumer familiarity, and broader distribution. A retailer can improve margins by shifting volume toward its own label, but it must maintain equivalent quality, reliable supply, and clear shelf differentiation.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can create value in four areas.

Cost reduction

A supplier can offer co-processed fillers or direct-compression systems that reduce granulation, improve throughput, and lower tablet defects. The commercial case depends on demonstrated savings per million tablets, not on ingredient novelty.

Manufacturing robustness

Excipient systems that reduce sticking, picking, capping, or weight variation can improve line utilization. A supplier should quantify:

• Compression speed.
• Tablet rejection rate.
• Lubrication sensitivity.
• Hardness variation.
• Disintegration time.
• Dissolution consistency.
• Changeover time.

Product extensions

A qualified platform can support:

• Ibuprofen PM caplets.
• Softgels.
• Smaller tablets.
• Liquid-filled capsules.
• Value-size packages.
• Single-dose travel packs.
• Day-and-night analgesic bundles.

Supply-chain resilience

Dual-source qualification, regional inventory, and predictable lead times have direct value in private-label OTC manufacturing. Retailers are sensitive to stockouts because shelf substitution is easy and consumer loyalty to a specific store-brand SKU is limited.

What manufacturing and IP barriers affect market entry?

The barriers are operational rather than patent-based. A new manufacturer must establish:

• FDA-compliant OTC manufacturing.
• Validated blending and compression processes.
• Uniformity and dissolution testing.
• Stability data supporting labeled shelf life.
• Packaging compatibility.
• Child-resistant packaging where required.
• Approved suppliers for active ingredients and excipients.
• Retailer qualification and audit readiness.

Ibuprofen supply is globally competitive, but the manufacturer must control impurity profiles, particle-size variation, residual solvents, and lot-to-lot performance. Diphenhydramine citrate also requires controlled identity, assay, and impurity testing.

The largest practical risks are formulation transfer failure, dissolution variability, coating defects, supply interruptions, and retailer rejection after quality audits.

What generic launch scenarios exist for Signature Care Ibuprofen PM?

Three launch scenarios are commercially realistic:

1. Low-cost tablet launch: The entrant uses a conventional immediate-release caplet and competes on price, package count, and retailer margin.
2. Premium delivery launch: The entrant offers a softgel, smaller tablet, or fast-disintegrating dosage form with a higher retail price.
3. Retailer-exclusive launch: The manufacturer supplies a custom product to a competing pharmacy, grocery, or mass-market chain.

The first scenario has the lowest technical risk and the highest price pressure. The second has greater differentiation but requires stronger formulation development and substantiation. The third can produce volume but increases dependence on one customer.

Key Takeaways

• Signature Care Ibuprofen PM is a conventional OTC combination product, typically containing ibuprofen 200 mg and diphenhydramine citrate 38 mg.
• Its core commercial protection comes from private-label distribution, pricing, and retailer control, not patent exclusivity.
• A conventional tablet does not present a material Orange Book or Paragraph IV risk profile.
• The most important excipient objectives are dissolution, content uniformity, compression performance, coating integrity, and low manufacturing cost.
• Direct compression is attractive when powder flow and tablet robustness are acceptable; granulation is justified only when it solves a measurable process problem.
• The strongest formulation opportunities are softgels, rapid-disintegration tablets, smaller caplets, taste-masked systems, and supply-chain-efficient excipient platforms.
• Retailer economics, product availability, and supplier qualification are more important than patent duration.
• Excipient suppliers should sell measurable manufacturing improvements rather than novel ingredients without a clear cost or performance benefit.

FAQs About Signature Care Ibuprofen PM

Is Signature Care Ibuprofen PM equivalent to Advil PM?

The products are generally designed around the same therapeutic combination, but equivalence depends on the exact active-ingredient strengths, dosage form, labeling, and inactive ingredients listed for each product.

Can a manufacturer patent a new ibuprofen PM formulation?

Yes. A manufacturer may pursue patents for a novel softgel vehicle, rapid-release system, taste-masking architecture, excipient ratio, manufacturing process, or stability improvement. The basic active-ingredient combination is unlikely to provide meaningful new patent protection.

Does diphenhydramine citrate 38 mg equal 25 mg of diphenhydramine hydrochloride?

Typically, 38 mg of diphenhydramine citrate is used to provide the equivalent of 25 mg of diphenhydramine hydrochloride, subject to the product’s approved labeling and specification.

What is the main quality risk in an ibuprofen PM tablet?

Dissolution and content uniformity are major risks because ibuprofen is poorly water-soluble and can segregate or behave inconsistently during blending and compression.

Can a private-label ibuprofen PM product be launched without an ANDA?

A product that complies with the applicable OTC monograph or final order framework generally does not require an ANDA. The manufacturer must still meet FDA manufacturing, labeling, testing, registration, and reporting requirements.

References

1. U.S. Food and Drug Administration. (2022). 21 CFR Part 331: Labeling of drug products for over-the-counter human use: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

2. U.S. Food and Drug Administration. (2022). 21 CFR Part 329: Labeling of drug products for over-the-counter human use: Drug products containing analgesic or antipyretic active ingredients. Electronic Code of Federal Regulations.

3. U.S. Food and Drug Administration. (2022). 21 CFR Part 333: Topical antimicrobial, analgesic, and anesthetic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

4. U.S. Food and Drug Administration. (2023). 21 CFR Part 201: Labeling. Electronic Code of Federal Regulations.

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

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