List of Excipients in Branded Drug GOOD SENSE IBUPROFEN PM

Generic Drugs Containing GOOD SENSE IBUPROFEN PM

Company	Ingredient	NDC	Excipient
L Perrigo Company	diphenhydramine citrate, ibuprofen	0113-0050	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	diphenhydramine citrate, ibuprofen	0113-0050	CROSCARMELLOSE SODIUM
L Perrigo Company	diphenhydramine citrate, ibuprofen	0113-0050	FD&C BLUE NO. 2 ALUMINUM LAKE
L Perrigo Company	diphenhydramine citrate, ibuprofen	0113-0050	FERROSOFERRIC OXIDE
L Perrigo Company	diphenhydramine citrate, ibuprofen	0113-0050	GLYCERYL DIBEHENATE

What are the Most Frequently-Used Excipients in GOOD SENSE IBUPROFEN PM?

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

Last updated: August 10, 2026

ecutive summary: Good Sense Ibuprofen PM is an OTC dual-active product combining ibuprofen 200 mg with diphenhydramine citrate 38 mg per tablet. Its commercial position depends on low-cost manufacturing, reliable tablet performance, retailer distribution, and packaging rather than molecule-level exclusivity. The strongest excipient opportunities are differentiated immediate-release tablets, fast-disintegrating or mini-tablet formats, liquid-filled capsules, abuse-resistant packaging, and formulation improvements that reduce gastrointestinal burden or improve nighttime tolerability. The principal barriers are FDA OTC monograph compliance, bioequivalence expectations, commodity pricing, and the limited ability to obtain broad patent claims around conventional excipients.

Good Sense Ibuprofen PM Excipient Strategy and Commercial Opportunities

What is Good Sense Ibuprofen PM?

Good Sense Ibuprofen PM is a private-label OTC nighttime analgesic and sleep-aid product. The standard labeled dosage contains:

Component	Amount per unit	Function
Ibuprofen	200 mg	Analgesic and antipyretic NSAID
Diphenhydramine citrate	38 mg	Nighttime sleep aid; equivalent to 25 mg diphenhydramine base

The product is positioned as a lower-cost alternative to branded ibuprofen/diphenhydramine products such as Advil PM. The formulation is generally an immediate-release solid oral dosage form, most commonly a film-coated tablet or caplet.

The product falls within established OTC regulatory categories. Ibuprofen is governed by the FDA’s internal analgesic, antipyretic, and antirheumatic monograph framework, while diphenhydramine is covered by the OTC sleep-aid monograph framework. FDA OTC monographs establish active-ingredient conditions, permitted indications, labeling, and dosing requirements.[1][2]

What excipients are used in Good Sense Ibuprofen PM?

Public product labels identify inactive ingredients, but the exact supplier, grade, particle-size distribution, manufacturing process, and quantitative composition are usually not disclosed. Typical excipient architecture for this product class includes:

Excipient category	Likely technical role
Microcrystalline cellulose	Diluent and compression aid
Pregelatinized starch or starch-based disintegrant	Tablet structure and breakup
Croscarmellose sodium or sodium starch glycolate	Rapid disintegration
Povidone	Binder
Colloidal silicon dioxide	Glidant and moisture-control aid
Magnesium stearate	Lubricant
Hypromellose	Film-coating polymer
Polyethylene glycol	Plasticizer in film coating
Talc	Anti-tacking and coating aid
Titanium dioxide or colorants	Opacity and product identification

The commercial objective is not to maximize excipient novelty. It is to produce a tablet that meets dissolution, assay, content uniformity, hardness, friability, stability, and packaging requirements at the lowest landed cost.

Ibuprofen creates a formulation challenge because it is poorly water-soluble and can have high tablet weight at a 200 mg dose. Diphenhydramine citrate adds a second active with different flow, compaction, taste, and stability behavior. A robust formulation must prevent segregation between the two active ingredients and maintain rapid release after compression.

How should the excipient strategy be designed?

Immediate-release tablet strategy

The base strategy should use a conventional direct-compression or dry-granulation platform. A practical formulation screen would compare:

1. Microcrystalline cellulose and mannitol blends for compressibility and mouthfeel.
2. Croscarmellose sodium versus sodium starch glycolate for disintegration.
3. Colloidal silicon dioxide levels for flow improvement.
4. Magnesium stearate concentration and blending time to limit over-lubrication.
5. Hypromellose film coatings with low moisture permeability.

Direct compression is attractive because it reduces water exposure, shortens processing time, and avoids a wet-granulation step that can increase cost and complicate stability. Dry granulation may be preferable if the active blend has poor flow or high segregation risk.

The formulation target should be rapid tablet breakup without compromising mechanical strength. Excess lubricant, excessive compression force, or a highly hydrophobic coating can slow dissolution. Those risks are material because both active ingredients are intended for immediate release.

Moisture and stability management

Excipient selection should account for the sensitivity of the actives and the target shelf life. A low-moisture process, controlled relative humidity, and high-barrier packaging can reduce degradation and tablet softening.

Relevant controls include:

• Low-moisture excipient grades.
• Desiccant-containing bottles where justified.
• Induction seals and child-resistant closures.
• High-barrier blister films for unit-dose packaging.
• Tight control of coating-pan inlet humidity.
• Compatibility testing between magnesium stearate, coating polymers, and active ingredients.

The commercial decision is a tradeoff. Bottles usually have lower packaging cost and better retail efficiency. Blisters can support portability, adherence, dose tracking, and product differentiation but increase material and conversion expense.

Taste and swallowability

Ibuprofen can produce an unpleasant taste if the tablet chips, the coating is incomplete, or the product is chewed. A smooth, low-friction film coat improves swallowability and can reduce consumer complaints.

Potential excipient innovations include:

• A denser film coat with improved mechanical resistance.
• Polymer-lipid coating systems that reduce active release in the mouth.
• Smaller, higher-density caplets.
• Multiparticulate capsules containing coated pellets.
• Rapidly disintegrating tablets with taste-masking particles.

A taste-masked product may support use by consumers who have difficulty swallowing conventional caplets. It also creates a more defensible formulation position than simply replacing one standard disintegrant with another.

What formulation patents could protect an ibuprofen PM product?

Broad patents on ibuprofen, diphenhydramine, microcrystalline cellulose, starch, or conventional tablet excipients are unlikely to provide meaningful protection because these materials are established and widely used. Patent value would come from a specific combination of composition, process, performance, or dosage form.

Potential claim categories include:

Patent category	Potential claim subject
Composition	Defined active-to-excipient ratio with measurable dissolution or stability results
Particle engineering	Ibuprofen or diphenhydramine particles with controlled size or surface treatment
Coating	Taste-masking or moisture-barrier coating with specified polymer architecture
Dosage form	Mini-tablet, bilayer tablet, orally disintegrating tablet, or liquid-filled capsule
Manufacturing	Dry granulation, compaction, blending, or coating process that reduces segregation
Packaging	Unit-dose system with moisture protection and child-resistant functionality
Performance	Rapid dissolution, reduced food effect, or improved stability under accelerated conditions

A patent application would need more than a list of known excipients. Claims are stronger when supported by comparative data showing a technical effect, such as faster dissolution, lower degradation, improved content uniformity, lower friability, or reduced coating defects.

A formulation patent may be commercially useful even when it does not block all competing ibuprofen/diphenhydramine products. It can protect a specific premium variant, manufacturing platform, or private-label supply agreement.

What is the FDA regulatory status of Good Sense Ibuprofen PM?

The product is an OTC drug rather than an FDA-approved prescription product. Its regulatory pathway is based primarily on compliance with applicable OTC monographs and labeling requirements.

Key regulatory points are:

Issue	Commercial implication
OTC monograph pathway	No conventional NDA approval is required for a compliant monograph product
Ibuprofen dose	Standard OTC strength is 200 mg per unit
Diphenhydramine dose	38 mg diphenhydramine citrate corresponds to 25 mg diphenhydramine base
Labeling	Must comply with analgesic, sleep-aid, warning, and age-use requirements
Manufacturing	Must comply with current good manufacturing practice
Formulation change	May require quality, stability, dissolution, and regulatory assessment
Product listing	Manufacturer and product information must be submitted through FDA drug listing systems

FDA’s OTC monograph system does not eliminate the need for product-specific quality controls. A change in excipient grade, coating system, granulation process, or packaging may affect dissolution and stability and must be supported by appropriate development data.[1][2][3]

What is the Orange Book status of Good Sense Ibuprofen PM?

Good Sense Ibuprofen PM is generally not an Orange Book-centered product. The Orange Book primarily covers approved prescription and certain approved OTC drug products, including therapeutic equivalence information. A monograph-compliant OTC product does not normally obtain market protection through Orange Book-listed patents in the same way as an NDA product.[4]

The commercial result is important:

• There is no meaningful NCE exclusivity position.
• There is usually no Orange Book patent dispute tied to the branded private-label product.
• Paragraph IV litigation is not the normal entry mechanism.
• Competitors can market comparable products if they meet OTC monograph, labeling, quality, and manufacturing requirements.
• Any protection must come from formulation, process, packaging, trademark, supply-chain, or contractual rights.

Patent litigation is more likely to arise around a branded formulation, a delivery technology, or a manufacturing process than around the standard Good Sense product itself.

When does Good Sense Ibuprofen PM lose exclusivity?

Good Sense Ibuprofen PM does not have a conventional patent exclusivity expiration date. Its market position is open to competing OTC products from the outset, subject to FDA requirements.

The relevant commercial protections are:

Protection	Expected durability
Ibuprofen and diphenhydramine active ingredients	No practical molecule-level exclusivity
OTC monograph compliance	Regulatory permission, not market exclusivity
Good Sense trademark and packaging	Brand-specific protection
Retail distribution	Contractual and channel advantage
Supplier manufacturing process	Confidential know-how or contract rights
Formulation patent	Potentially 20 years from earliest nonprovisional filing, subject to validity and scope
Packaging patent	Potentially 20 years from earliest nonprovisional filing
Trade secrets	Indefinite while secrecy is maintained

The absence of formal exclusivity makes cost, fill rate, packaging efficiency, and retailer relationships central competitive factors.

What commercial opportunities exist for new excipient platforms?

Premium rapid-onset product

A formulation using micronized ibuprofen, wetting agents, or engineered particles could target faster dissolution. The product would need to preserve immediate-release labeling and demonstrate a meaningful performance advantage without creating a new safety or labeling issue.

Potential value lies in:

• Faster tablet disintegration.
• Improved ibuprofen dissolution.
• Lower variability after fed administration.
• Smaller tablet size.
• Premium pricing relative to standard private label.

The challenge is that faster dissolution does not automatically establish faster clinical pain relief. Marketing claims must remain consistent with supporting evidence and FDA requirements.

Lower-gastrointestinal-burden positioning

Excipient systems can improve dispersion and reduce local concentration of ibuprofen in the stomach, but they cannot remove the systemic NSAID risks associated with ibuprofen. Enteric protection is generally poorly aligned with a nighttime immediate-release product because delayed release could reduce onset and create dosing uncertainty.

A more commercially practical approach is a formulation that improves tablet dispersion, reduces dose variability, and supports lower excipient irritation. The product should not imply that excipients eliminate NSAID gastrointestinal or cardiovascular warnings.

Small-format and easy-swallow products

A high-density caplet, mini-tablet capsule, or multiparticulate system could address consumers who reject large PM tablets. This opportunity is strongest in:

• Older adults.
• Consumers with swallowing difficulty.
• Travel and convenience channels.
• E-commerce multipacks.
• Retail clinic and pharmacy settings.

The main development issue is dose uniformity across multiple units and maintaining immediate release for both actives.

Liquid-filled softgel or hard capsule

A liquid-filled capsule can improve consumer perception, swallowing, and product differentiation. It also creates technical opportunities through solubilization and suspension systems.

Risks include:

• Higher manufacturing cost.
• Shell compatibility.
• Leakage and cross-linking.
• Stability of the suspension.
• More expensive packaging.
• Potentially weaker price competitiveness against tablets.

This format is better suited to a branded or premium private-label SKU than to the lowest-cost Good Sense tier.

Packaging and adherence products

Unit-dose blister packs, calendarized nighttime packs, and senior-friendly packaging can create commercial differentiation without changing the active ingredients. Packaging patents and design protection may be more practical than broad composition claims.

A packaging platform could support:

• Controlled nighttime dosing.
• Reduced accidental double dosing.
• Travel portability.
• Retail-ready unit doses.
• Integration with digital reminders.

Packaging must preserve required warnings and avoid implying that the product is safer than the labeled active ingredients.

How does Good Sense compare with Advil PM?

Attribute	Good Sense Ibuprofen PM	Advil PM
Active ingredients	Ibuprofen 200 mg plus diphenhydramine citrate 38 mg	Same core active combination in standard products
Market position	Private label, value pricing	National brand
Primary advantage	Lower price and retailer control	Brand recognition and product familiarity
Patent leverage	Limited for standard monograph product	Potentially greater brand and formulation history, but core actives are mature
Excipient opportunity	Cost reduction and retailer-specific formats	Premium delivery, packaging, and consumer experience
Generic competition	High	High at the active-ingredient level
Main moat	Distribution, price, supply reliability	Brand equity, marketing, and shelf presence

A new entrant should avoid competing solely on the standard tablet. The lowest-cost segment is likely to be dominated by private labels and established OTC manufacturers. A differentiated formulation needs a clear consumer benefit or a measurable manufacturing advantage.

Which companies are positioned to supply or challenge this product category?

The category is accessible to large OTC manufacturers, private-label suppliers, contract development and manufacturing organizations, and retailers with established pharmacy distribution. Competitive capabilities include:

• High-volume tablet compression.
• OTC monograph regulatory expertise.
• Film coating and packaging.
• Blister and bottle conversion.
• Active-ingredient sourcing.
• Retailer private-label qualification.
• Stability and dissolution testing.

Potential competitors are not limited to products carrying the Good Sense name. They include Advil PM, generic ibuprofen/diphenhydramine products, store-brand nighttime pain relievers, and combination products containing acetaminophen and diphenhydramine.

Supplier selection should emphasize FDA inspection history, validated cleaning for potent or sensitizing materials, supply continuity for ibuprofen and diphenhydramine, and the ability to qualify alternate excipient grades.

What generic entry risks exist for Good Sense Ibuprofen PM?

Generic entry risk is structurally high because the active ingredients are mature and the product is generally sold under OTC monograph conditions. The principal risks are operational rather than patent-driven:

• Price erosion from multiple store brands.
• Retailer replacement by a lower-cost supplier.
• Shortages of ibuprofen or diphenhydramine.
• Excipient or packaging cost inflation.
• Dissolution failure after a formulation change.
• Recall exposure from content-uniformity or labeling errors.
• Channel substitution by acetaminophen/diphenhydramine products.
• Consumer migration to liquid gels or single-ingredient products.

A differentiated excipient platform can reduce direct price competition, but only if it produces a visible consumer benefit or a defensible cost advantage.

What licensing opportunities exist for ibuprofen PM excipients?

Licensing targets could include:

• Ibuprofen particle-engineering technologies.
• Taste-masking and coating systems.
• Fast-disintegration platforms.
• Liquid-filled capsule technologies.
• Moisture-barrier films.
• Child-resistant unit-dose packaging.
• Continuous manufacturing and dry-granulation systems.

A license is commercially attractive when it provides one of four outcomes: lower manufacturing cost, faster development, a regulatory advantage, or a product claim that competitors cannot easily reproduce.

A conventional excipient combination generally has limited licensing value because suppliers can often substitute equivalent grades. A proprietary technology should therefore be supported by composition-of-matter claims, process claims, trade secrets, or validated performance data.

Key takeaways

• Good Sense Ibuprofen PM is a mature OTC combination of ibuprofen 200 mg and diphenhydramine citrate 38 mg.
• The product has little practical molecule-level or Orange Book exclusivity.
• Conventional excipients are valuable for manufacturability but rarely create broad patent protection.
• The strongest formulation opportunities are rapid-disintegration tablets, smaller dosage forms, taste-masked multiparticulates, liquid-filled capsules, and improved moisture-barrier packaging.
• Commercial success depends on retail distribution, cost control, reliable supply, and compliance with FDA OTC monograph requirements.
• Formulation patents should claim defined compositions, measurable performance, particle engineering, manufacturing processes, or packaging systems.
• Paragraph IV litigation is generally not the central risk for a monograph-compliant product.
• Premium differentiation is more defensible than a standard low-cost tablet, but it must justify higher manufacturing and packaging costs.

FAQs about Good Sense Ibuprofen PM excipient and IP strategy

Can a new company patent a standard ibuprofen and diphenhydramine tablet?

A basic tablet using established excipients is unlikely to support strong broad claims. Patentability improves when the formulation has a defined composition and demonstrated technical results, such as improved dissolution, stability, taste masking, or content uniformity.

Is diphenhydramine citrate different from diphenhydramine hydrochloride for formulation purposes?

Yes. The salt affects molecular weight, hygroscopicity, flow, solubility, tablet weight, and compatibility. A formulation cannot freely substitute one salt for the other without reassessing assay, dose equivalence, stability, and dissolution.

Can an ibuprofen PM product use an enteric coating?

It can, but enteric protection may conflict with the commercial objective of immediate nighttime relief. The coating would require dissolution and labeling evaluation and could create delayed-onset or food-effect concerns.

Are OTC monograph products protected by FDA exclusivity?

No. OTC monograph compliance provides a regulatory marketing pathway, not a conventional exclusivity period. Brand, trademark, patent, trade-secret, and contractual rights may still provide commercial protection.

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

A cost-efficient immediate-release formulation with robust flow, rapid disintegration, strong moisture protection, and a smaller swallowable tablet is the most practical base opportunity. Premium formats should be pursued only where the retailer can support higher pricing.

References

1. U.S. Food and Drug Administration. (2022). Over-the-counter monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. FDA.

2. U.S. Food and Drug Administration. (2022). Over-the-counter monograph M012: Nighttime sleep aid drug products. FDA.

3. U.S. Food and Drug Administration. (2023). Current good manufacturing practice requirements for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. FDA.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. FDA.