List of Excipients in Branded Drug GOOD SENSE IBUPROFEN

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Generic Drugs Containing GOOD SENSE IBUPROFEN

Company	Ingredient	NDC	Excipient
L Perrigo Company	ibuprofen	0113-0057	ANHYDROUS CITRIC ACID
L Perrigo Company	ibuprofen	0113-0057	FD&C RED NO. 40
L Perrigo Company	ibuprofen	0113-0057	GLYCERIN

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

# Of NDCs	Excipient
2	ACESULFAME POTASSIUM
2	AMMONIA
7	ANHYDROUS CITRIC ACID

GoodSense Ibuprofen Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

GoodSense ibuprofen is an over-the-counter, private-label ibuprofen business rather than a single globally standardized formulation. Its commercial position depends on low-cost execution, FDA monograph compliance, reliable dissolution, package differentiation, and retailer distribution. The core 200 mg immediate-release tablet has limited molecule-level exclusivity risk because ibuprofen is an established, off-patent active ingredient. The main opportunities are formulation line extensions, delivery-format improvements, packaging, contract manufacturing, and retailer-specific products.

What is GoodSense ibuprofen?

GoodSense ibuprofen is a private-label OTC analgesic and antipyretic product sold under the GoodSense brand. The brand has been used for multiple ibuprofen formats, including:

Product format	Typical strength	Primary commercial use
Immediate-release tablet or caplet	200 mg	Adult and pediatric OTC pain and fever relief
Softgel or liquid-filled capsule	200 mg	Easier swallowing and faster perceived onset
Oral suspension	Pediatric strengths	Children who cannot swallow tablets
Combination products	Varies	Pain, fever, cold, or menstrual-symptom positioning

The active ingredient is ibuprofen, a nonsteroidal anti-inflammatory drug. U.S. OTC ibuprofen products generally operate under the FDA internal analgesic, antipyretic, and antirheumatic monograph framework, including the dosing and labeling requirements in 21 C.F.R. § 343 and the FDA OTC monograph system.[1][2]

GoodSense should therefore be analyzed at the SKU level. Inactive ingredients can differ between tablets, coated caplets, softgels, and liquids. A label or DailyMed record for one GoodSense SKU does not establish the formulation of every GoodSense ibuprofen product.[3]

What excipients are used in GoodSense ibuprofen tablets?

Representative immediate-release ibuprofen tablets typically use excipients in five functional groups: diluents, binders, disintegrants, lubricants, and film-coating materials.

Excipient function	Common candidates	Technical purpose
Diluent	Microcrystalline cellulose, lactose, starch, dibasic calcium phosphate	Provides tablet mass and compressibility
Binder	Povidone, pregelatinized starch, hypromellose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Promotes tablet breakup after ingestion
Glidant	Colloidal silicon dioxide	Improves powder flow
Lubricant	Magnesium stearate, stearic acid, sodium stearyl fumarate	Reduces sticking and ejection force
Surfactant or wetting agent	Sodium lauryl sulfate, poloxamer	Improves wetting of poorly soluble ibuprofen
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, colorants	Improves swallowability, appearance, and handling

The principal formulation problem is ibuprofen’s low aqueous solubility. Ibuprofen is commonly treated as a dissolution-sensitive, poorly water-soluble active, so the choice of particle size, wetting agent, granulation process, lubricant level, and disintegrant system affects release performance.[4]

A cost-optimized tablet can use direct compression with microcrystalline cellulose, a superdisintegrant, colloidal silicon dioxide, and a low lubricant concentration. Wet granulation may improve content uniformity and manufacturability but increases process cost and creates additional moisture-control requirements.

How should an excipient strategy be designed for GoodSense ibuprofen?

The preferred strategy is a platform formulation with controlled variations for different retail formats. The base product should prioritize rapid disintegration, reproducible dissolution, low tablet weight, and a broad supplier base.

Immediate-release tablet strategy

A practical tablet platform would use:

1. Microcrystalline cellulose or a cellulose-starch blend for compressibility.
2. Croscarmellose sodium, crospovidone, or sodium starch glycolate for rapid disintegration.
3. Colloidal silicon dioxide for flow control.
4. Magnesium stearate or sodium stearyl fumarate at a controlled concentration.
5. A thin hypromellose-based film coat where appearance and swallowability justify the cost.

The formulation should avoid excessive hydrophobic lubricant or over-lubrication. These factors can slow wetting and dissolution. Process controls should include blend uniformity, tablet hardness, friability, disintegration, dissolution, assay, and degradation products.

Film-coated caplet strategy

A caplet can support a “coated for easier swallowing” position without changing the active ingredient. The coating should be thin enough to avoid a meaningful dissolution penalty. Hypromellose and polyethylene glycol are standard coating components. Titanium dioxide and colorants can be removed for a dye-free or simplified-excipient version, subject to product appearance and labeling requirements.

Softgel strategy

A liquid-filled softgel can use a solubilizing or dispersing vehicle such as polyethylene glycol or a lipid-based carrier. Gelatin, glycerin, sorbitol, and purified water are typical shell components, although exact systems vary by manufacturer.

Softgels may create a stronger consumer proposition than a conventional caplet because they are easier to swallow and can be marketed as a premium delivery format. They also introduce higher manufacturing cost, shell brittleness risk, fill migration, gelatin cross-linking concerns, and greater dependence on specialized contract manufacturers.

The commercial case is strongest where the retailer wants a premium private-label alternative rather than the lowest-cost 200 mg tablet.

Pediatric liquid strategy

An oral suspension requires a separate excipient architecture:

• Suspending agents such as xanthan gum or cellulose derivatives.
• Wetting agents such as polysorbates where needed.
• Buffers to control pH.
• Sweeteners and flavors for palatability.
• Preservatives where justified by the formulation and container system.
• Chelating agents or antioxidants where stability data support their use.

The product should be evaluated for sedimentation, redispersibility, dosing accuracy, viscosity, microbial quality, preservative effectiveness, and compatibility with oral syringes. Pediatric positioning increases the importance of low-risk excipient selection and clear dosing devices.

What formulations are protected by GoodSense ibuprofen?

No public information indicates that the GoodSense brand itself has a material proprietary excipient platform covering ordinary ibuprofen tablets. The principal commercial protection is brand, retailer access, supply capability, packaging, quality performance, and cost.

Potentially protectable formulation concepts include:

• Rapid-release ibuprofen compositions.
• Liquid-filled capsule systems.
• Taste-masked pediatric suspensions.
• Stabilized high-concentration liquids.
• Low-moisture or moisture-barrier packaging.
• Manufacturing processes that improve dissolution or reduce defect rates.

A formulation patent would need claims that distinguish the product from known ibuprofen tablets and liquid systems. Routine use of microcrystalline cellulose, croscarmellose sodium, hypromellose, polyethylene glycol, or magnesium stearate is unlikely to create strong standalone patent protection because these materials are widely used in oral solid dosage forms.

For a private-label product, trade secrets and manufacturing know-how may have more practical value than patents. Examples include granulation endpoint controls, particle-size specifications, coating parameters, softgel fill processes, and validated packaging configurations.

What is the FDA regulatory status of GoodSense ibuprofen?

GoodSense ibuprofen is generally positioned as an OTC monograph product rather than an innovator prescription NDA product. FDA requirements focus on:

• Permitted active ingredient and strength.
• Eligible dosage form.
• Required warnings and directions.
• Labeling format.
• Manufacturing under current good manufacturing practice.
• Identity, strength, quality, and purity.
• Stability and container-closure performance.

The FDA’s OTC monograph system was restructured under the Coronavirus Aid, Relief, and Economic Security Act. Monograph drugs are governed through administrative orders and applicable FDA regulations rather than the same approval pathway used for a new prescription drug.[1]

An OTC monograph product does not receive the same market exclusivity architecture as a newly approved prescription NDA. The manufacturer must still establish that the product complies with applicable monograph conditions and manufacturing requirements.

What is the Orange Book status of GoodSense ibuprofen?

GoodSense ibuprofen should not be treated as an Orange Book-driven exclusivity product. The Orange Book primarily identifies approved prescription drug products, patents, and exclusivity information under the Hatch-Waxman framework.[5]

For a conventional OTC monograph ibuprofen product:

• There is generally no branded NDA patent listing comparable to a prescription product.
• There is no conventional five-year NCE exclusivity period.
• Paragraph IV certification is generally not the normal route for market entry.
• Competition usually comes from other OTC monograph-compliant manufacturers and private-label suppliers.

An individual ibuprofen product could have a different regulatory pathway if it were marketed under an NDA, but ordinary GoodSense ibuprofen products are commercially understood as OTC monograph products.

When does GoodSense ibuprofen lose exclusivity?

GoodSense ibuprofen has no meaningful active-ingredient exclusivity deadline comparable to a protected prescription drug. Ibuprofen has been marketed for decades, and the molecule is available to multiple manufacturers.

The relevant commercial timeline is:

Protection or barrier	Status
Ibuprofen composition-of-matter exclusivity	Expired
Conventional NCE exclusivity	Not applicable to ordinary OTC monograph ibuprofen
Orange Book patent barrier	Generally not the principal barrier
Brand protection	Continues while trademark and commercial use are maintained
Formulation protection	Depends on any specific patent or trade secret
Manufacturing barrier	Depends on validated capacity, quality systems, and supplier access
Retailer access	Contractual and commercial, not regulatory exclusivity

A competitor can normally enter by manufacturing a compliant ibuprofen product, securing a private-label or retail agreement, and meeting quality, labeling, and supply requirements.

Are there Paragraph IV challenges or generic-entry risks?

A conventional Paragraph IV challenge is not the primary risk for GoodSense ibuprofen because the product is generally not protected by an innovator NDA patent estate. The relevant entry risk is direct OTC competition.

Competitors may enter through:

• Private-label tablet production.
• National-brand ibuprofen products.
• Value retailers and pharmacy chains.
• E-commerce channels.
• Club-store multipacks.
• Softgel and liquid-filled capsule products.
• Pediatric liquid products.

The principal risks are price compression, retailer switching, manufacturing-cost advantages, stockouts, and product-quality events. Regulatory enforcement or a recall can affect the entire private-label relationship because the retailer’s brand is exposed even when a contract manufacturer made the product.

What patent litigation affects GoodSense ibuprofen?

No major patent-litigation barrier is inherent in ordinary GoodSense ibuprofen tablets. Litigation risk is more likely to involve:

• Alleged infringement of a specialized softgel formulation.
• Delivery-system patents.
• Combination-product claims.
• Packaging or dispensing systems.
• Trademark disputes involving the GoodSense name.
• Product-liability or quality claims rather than molecule patents.

Any patent analysis should identify the exact manufacturer, dosage form, NDC, and formulation. Broad searches for “ibuprofen patents” will overstate risk because many patents concern unrelated pharmaceutical compositions, specific release technologies, or expired claims.

Which companies are challenging GoodSense ibuprofen commercially?

Competition comes from manufacturers and retailers offering interchangeable OTC ibuprofen products. Relevant competitive groups include:

Competitor group	Competitive advantage
National analgesic brands	Consumer recognition and advertising
Pharmacy private labels	Retail placement and price
Mass merchants	High-volume purchasing and multipacks
E-commerce brands	Search visibility and fulfillment
Contract manufacturers	Scale, low unit cost, and multi-retailer production
Softgel specialists	Premium delivery formats
Pediatric-liquid manufacturers	Taste, dosing devices, and formulation expertise

The most credible threat to a standard GoodSense tablet is not a patented substitute. It is a lower-cost equivalent with better retail placement, a larger count size, or more reliable supply.

What commercial opportunities exist for GoodSense ibuprofen?

Premium delivery formats

Softgels, liquid-filled capsules, and easier-swallow caplets can support higher gross margins than standard tablets. The differentiation must be backed by consumer-relevant attributes, such as swallowability, package convenience, or a smaller tablet profile.

Retailer-specific formulations

Retailers can use the same ibuprofen platform with differentiated:

• Count sizes.
• Tablet colors and shapes.
• Bottle designs.
• Child-resistant closures.
• Travel packs.
• Club-store multipacks.
• E-commerce bundles.

These changes can create SKU-level differentiation without requiring a new active ingredient.

Pediatric products

Children’s ibuprofen suspensions offer a higher-value opportunity than commodity adult tablets, but they require greater investment in taste, viscosity, dosing accuracy, stability, and packaging. Concentrated suspensions may reduce package size, but concentration changes require careful compliance with labeling and dosing conventions.

Excipient simplification

A dye-free, sugar-free, alcohol-free, or reduced-excipient product can target consumers who prefer simplified labels. These claims must be accurate and supported by the final formulation. Removing an excipient can create new problems involving taste, suspension stability, tablet appearance, or microbial control.

Supply-chain localization

A manufacturer can improve retailer value by qualifying multiple suppliers for ibuprofen API, excipients, bottles, closures, cartons, and coatings. Dual sourcing reduces interruption risk. The most important quality controls involve API particle size, polymorphic form, impurity profile, and dissolution behavior.

Contract manufacturing and licensing

The commercial opportunity is strongest for manufacturers that can provide a complete service:

• Formulation development.
• FDA-compliant production.
• Stability programs.
• Packaging and serialization support.
• Retailer-specific labeling.
• Rapid SKU changes.
• Reliable high-volume supply.

A license for a differentiated delivery system may be useful, but ordinary ibuprofen tablets do not require a high-value drug license. Contract manufacturing agreements, formulation technology transfers, and retailer supply contracts are more commercially relevant than an originator-style license.

How strong is the GoodSense ibuprofen patent estate?

The patent estate is likely weak for the ordinary 200 mg tablet and stronger only where a specific delivery technology, formulation process, or combination product is involved.

Asset	Relative strength
Ibuprofen active ingredient	Very low patent barrier
Standard immediate-release tablet	Low
Conventional film coating	Low
Softgel formulation	Moderate if claims are narrow and technically differentiated
Pediatric suspension	Moderate where stability or taste-masking claims are novel
Manufacturing process	Moderate as trade secret; variable as patent
Brand and retailer position	Commercially important but not patent exclusivity

The defensible assets are likely to be operational rather than molecule-based: validated manufacturing, supply continuity, retailer agreements, quality history, and consumer recognition.

What generic launch scenarios exist for GoodSense ibuprofen?

Three launch scenarios are commercially realistic.

Low-cost tablet entry

A new supplier launches a 200 mg immediate-release tablet using standard excipients and competes on cost, count size, and retailer margin. This is the highest-probability entry scenario.

Premium softgel entry

A competitor launches liquid-filled capsules with a higher retail price and premium packaging. Success depends on consumer demand and retailer willingness to protect shelf space.

Pediatric or convenience-format entry

A competitor launches a suspension, travel-size package, unit-dose format, or e-commerce bundle. This route can avoid direct price comparison with large-count tablets.

What geographic coverage applies to GoodSense ibuprofen?

U.S. OTC compliance does not automatically establish rights or regulatory clearance in other markets. Ibuprofen products in Canada, the European Union, the United Kingdom, Australia, and emerging markets follow different labeling, dosage, excipient, and registration requirements.

The most portable commercial assets are:

• API supply relationships.
• Tablet and softgel manufacturing capability.
• Stability data.
• Packaging systems.
• Brand and retailer agreements.
• Formulation know-how.

Geographic expansion requires separate review of monograph status, maximum daily dose, pediatric use, warning language, excipient restrictions, and local product registration.

Key Takeaways

• GoodSense ibuprofen is primarily a private-label OTC business, not a drug with meaningful active-ingredient exclusivity.
• The standard 200 mg tablet has a low patent barrier and is vulnerable to direct private-label competition.
• The most important excipient issues are ibuprofen wetting, dissolution, disintegration, lubrication, tablet robustness, and stability.
• Softgels, pediatric suspensions, dye-free products, travel formats, and retailer-specific packaging offer the clearest commercial expansion paths.
• Ordinary OTC monograph ibuprofen generally does not create a conventional Orange Book or Paragraph IV litigation pathway.
• Manufacturing quality, supply reliability, retailer access, and formulation know-how are more important than composition-of-matter patents.
• A platform excipient strategy can support multiple GoodSense ibuprofen SKUs while controlling development and manufacturing costs.

FAQs

Is GoodSense ibuprofen the same as Advil?

Both products contain ibuprofen when labeled at the same strength, but they may differ in inactive ingredients, dosage form, tablet design, packaging, and price. Advil is a national brand; GoodSense is generally positioned as a private-label product.

Can GoodSense ibuprofen be reformulated with different excipients?

Yes. A manufacturer can change inactive ingredients if the resulting product remains compliant with applicable FDA requirements and maintains acceptable quality, stability, dissolution, labeling, and manufacturing performance.

Are ibuprofen excipients patentable?

Specific compositions or processes may be patentable if they are novel and non-obvious. Common excipients used in ordinary tablets are unlikely to create strong standalone patent protection.

Does a GoodSense ibuprofen softgel have stronger commercial protection than a tablet?

It can have stronger differentiation and higher manufacturing barriers, but commercial protection depends on the actual formulation, patents, contract manufacturer, retailer agreement, and consumer demand. The ibuprofen molecule itself remains unprotected.

What is the biggest business risk for GoodSense ibuprofen?

The largest risk is commodity price competition combined with supply disruption or a quality event. A private-label product can lose retailer support quickly if a lower-cost supplier offers equivalent quality or if the manufacturer cannot maintain consistent supply.

References

1. U.S. Food and Drug Administration. (2020). Over-the-counter monograph reform and the CARES Act. FDA.
2. Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use.
3. U.S. National Library of Medicine. (2024). DailyMed: Ibuprofen product labeling.
4. U.S. Food and Drug Administration. (2015). Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. FDA.
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.