List of Excipients in Branded Drug GOOD SENSE CHILDRENS IBUPROFEN

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Generic Drugs Containing GOOD SENSE CHILDRENS IBUPROFEN

Company	Ingredient	NDC	Excipient
L Perrigo Company	ibuprofen	0113-2461	ACESULFAME POTASSIUM
L Perrigo Company	ibuprofen	0113-2461	AMMONIUM GLYCYRRHIZATE
L Perrigo Company	ibuprofen	0113-2461	ASPARTAME
L Perrigo Company	ibuprofen	0113-2461	CARNAUBA WAX
L Perrigo Company	ibuprofen	0113-2461	CROSCARMELLOSE SODIUM

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

# Of NDCs	Excipient
3	ACESULFAME POTASSIUM
2	AMMONIUM GLYCYRRHIZATE
3	ASPARTAME
3	CARNAUBA WAX
3	CROSCARMELLOSE SODIUM

Last updated: October 19, 2026

ecutive summary: GoodSense Children’s Ibuprofen is a U.S. over-the-counter oral suspension containing ibuprofen 100 mg per 5 mL. Its commercial position depends less on active-ingredient exclusivity than on excipient performance, dosing accuracy, palatability, packaging, supply reliability, and retailer economics. The strongest opportunities are dye-free and sugar-free suspensions, improved taste masking, preservative-minimized systems, dosing-device differentiation, and concentrated formulations that reduce shipping and household volume. The core ibuprofen product is exposed to extensive generic competition and has no meaningful compound-patent barrier.

GoodSense Children’s Ibuprofen Excipient Strategy and Commercial Opportunities

What is GoodSense Children’s Ibuprofen?

GoodSense Children’s Ibuprofen is a private-label pediatric oral suspension product based on ibuprofen. The standard U.S. strength is 100 mg per 5 mL, consistent with the FDA over-the-counter monograph for oral ibuprofen products intended for children and adults [1,2].

Attribute	Product assessment
Brand	GoodSense
Product	Children’s Ibuprofen oral suspension
Active ingredient	Ibuprofen
Typical strength	100 mg per 5 mL
Dosage form	Oral suspension
Regulatory pathway	OTC monograph product
Primary use	Temporary reduction of fever and relief of minor aches and pains
Main competitors	Children’s Motrin, Advil Children’s, store brands, generic ibuprofen suspensions
Core commercial barrier	Consumer preference, retail placement, manufacturing cost, and supply execution
Core patent barrier	Low for conventional ibuprofen suspension

The precise inactive-ingredient profile can vary by GoodSense product configuration, flavor, manufacturer, and packaging presentation. A commercial excipient strategy should therefore be built around the approved product specification and current product label rather than the brand name alone.

What excipients are used in children’s ibuprofen suspension?

Pediatric ibuprofen suspensions generally require excipients in five functional groups:

1. Aqueous vehicle and viscosity modifiers.
2. Suspending and rheology-control agents.
3. Sweeteners and flavor systems.
4. pH-adjusting and buffering agents.
5. Preservatives, wetting agents, and processing aids.

Typical excipient functions are summarized below.

Excipient function	Commercial purpose	Key development risk
Purified water	Continuous liquid phase	Microbial control and preservative compatibility
Suspending agent	Keeps ibuprofen uniformly dispersed	Caking, sedimentation, redispersibility
Viscosity modifier	Controls pourability and dose uniformity	Poor flow or inaccurate dosing
Wetting agent	Improves ibuprofen dispersion	Foaming, taste, irritation
Sweetener	Reduces bitterness	Dental and metabolic positioning
Flavor	Improves adherence and repeat use	Taste masking failure or allergen concerns
Buffer or pH adjuster	Controls pH and stability	Flavor impact and preservative performance
Preservative	Controls microbial growth	Regulatory, tolerability, and consumer acceptance
Antifoam or processing aid	Improves manufacturing and filling	Labeling and process compatibility
Colorant	Product identification and appearance	Dye-free demand and consumer sensitivity

Ibuprofen is practically insoluble in water. The formulation therefore must maintain a stable dispersion rather than a true solution. Particle-size distribution, wetting, viscosity, density, and sedimentation behavior directly affect dose uniformity and patient usability.

The most important performance test is not initial appearance. It is the ability of the suspension to redisperse after storage and deliver a consistent dose after realistic household handling.

Which excipient attributes matter most for pediatric ibuprofen?

Suspension stability and dose uniformity

A pediatric suspension must remain physically stable during storage while still pouring easily. Excessive viscosity can improve sedimentation control but create inaccurate dosing, bottle retention, and difficulty for caregivers. Low viscosity can improve pouring but increase settling and dose variability.

The target is controlled thixotropy: the product should be relatively stable at rest and become easier to pour after shaking. Development work should measure:

• Sedimentation volume.
• Redispersibility after defined storage intervals.
• Particle-size distribution.
• Pourability through the intended dosing syringe or cup.
• Dose uniformity at beginning, middle, and end of bottle use.
• Performance after temperature cycling and shipping stress.

Taste masking

Ibuprofen has a pronounced bitter taste. Pediatric adherence depends on controlling bitterness, aftertaste, mouth coating, and flavor persistence. Increasing sweetener alone rarely solves the problem.

A stronger strategy combines:

• Efficient wetting and particle-size control.
• A suitable suspending matrix.
• High-intensity sweetener with a bulk sweetener where appropriate.
• Flavor systems selected through pediatric sensory testing.
• Reduced exposure of ibuprofen particles in the oral cavity.
• A short, clean aftertaste.

Berry, grape, and fruit-punch profiles are common in pediatric analgesics. A differentiated product can use a lower-intensity flavor system with better bitterness suppression rather than simply increasing sweetness.

Sugar and caloric profile

A sugar-containing suspension can improve body and taste but limits positioning for parents seeking sugar-free products. A sugar-free system can use polyols, high-intensity sweeteners, and suitable viscosity modifiers, but polyols may introduce gastrointestinal tolerance issues at higher exposure.

Commercially relevant options include:

Positioning	Excipient strategy	Commercial advantage
Standard economy	Conventional sweetener, flavor, suspension system	Lowest cost and broad retail appeal
Sugar-free	Non-sugar sweetener and polyol or polymer-based body	Appeals to health-conscious consumers
Dye-free	No synthetic colorant	Supports clean-label positioning
Low-excipient	Reduced flavor, color, and preservative burden	Simpler label and sensitive-consumer appeal
Premium taste	Advanced flavor and bitterness-control system	Higher potential price and repeat purchase
Concentrated	Higher ibuprofen concentration with adjusted rheology	Smaller dose volume and lower logistics cost

The sugar-free and dye-free claims must be supported by the final formulation and label. A claim that removes one excipient concern while adding another, such as excessive polyol or artificial sweetener use, can weaken the product proposition.

What formulation opportunities exist for GoodSense Children’s Ibuprofen?

Dye-free ibuprofen suspension

Dye-free pediatric products have a clear commercial rationale. Parents may avoid artificial colors because of preference, perceived sensitivity, or household purchasing policy. Removing color can reduce formulation complexity and avoid colorant-related variability.

The main technical challenge is appearance. A dye-free suspension may look less distinctive or less uniform. Packaging, bottle design, flavor naming, and clear labeling must compensate for the absence of color.

Sugar-free pediatric ibuprofen

Sugar-free formulations can expand use among households managing sugar intake and reduce concerns about prolonged exposure during repeated dosing. The formulation must preserve mouthfeel and taste without creating an excessive cooling effect, lingering sweetness, or gastrointestinal burden.

Sugar-free development should compare:

• Sucralose-based systems.
• Saccharin-based systems.
• Acesulfame potassium combinations.
• Polyol-containing systems.
• Polymer-based viscosity and mouthfeel systems.

The preferred system is the one that balances taste, microbial robustness, viscosity, and cost. The lowest ingredient count is not automatically the lowest-cost or lowest-risk option.

Preservative-minimized or preservative-free presentations

A multidose aqueous suspension has microbial-control requirements. Preservative-free packaging is more difficult but commercially attractive if it can be achieved through unit-dose packaging, metered-dose delivery, or a validated antimicrobial container system.

Potential formats include:

• Single-dose sachets.
• Unit-dose cups.
• Small-volume premeasured tubes.
• Metered oral dispensers.
• Powder-for-reconstitution products.

The tradeoff is packaging cost. A preservative-free unit-dose product may be commercially viable in hospitals, travel, daycare, or premium retail channels, but it is less likely to compete with low-cost multidose store brands.

Concentrated ibuprofen suspension

A concentrated pediatric product could reduce administration volume. The standard 100 mg per 5 mL strength requires relatively large volumes for older children. A higher-strength suspension could improve convenience and reduce shipping weight.

The risks include:

• Dosing errors between concentrations.
• Accidental substitution with standard-strength products.
• Greater need for an oral syringe.
• More demanding taste masking.
• Higher local irritation or intolerance if formulation design is poor.
• Packaging and labeling requirements to prevent caregiver confusion.

Concentration changes should be paired with a dedicated syringe and prominent dose tables. The commercial opportunity is strongest when the product is positioned around reduced volume rather than simply higher potency.

How does GoodSense compare with competing children’s ibuprofen products?

Factor	GoodSense/store brand	Children’s Motrin	Advil Children’s	Premium opportunity
Price	Usually strongest	Higher brand premium	Higher brand premium	Selective premium
Active ingredient	Ibuprofen	Ibuprofen	Ibuprofen	Same active
Standard strength	Commonly 100 mg/5 mL	Commonly 100 mg/5 mL	Commonly 100 mg/5 mL	Concentrated alternative
Differentiation	Retailer value and availability	Brand recognition	Brand recognition	Taste, dosing, excipients
Patent protection	Limited practical protection	Limited practical protection	Limited practical protection	Formulation or delivery IP
Consumer purchase driver	Price and convenience	Trust and familiarity	Trust and familiarity	Clean-label or reduced-volume claims
Retail leverage	High through private label	National brand marketing	National brand marketing	Specialty channel expansion

GoodSense competes primarily through retailer access, price, and supply. It is less likely to win through conventional ibuprofen chemistry, which is widely available, and more likely to win through packaging, flavor, excipient claims, and reliable in-stock performance.

What patents protect children’s ibuprofen formulations?

Conventional ibuprofen is a mature active ingredient with no meaningful new-molecule exclusivity for a standard pediatric suspension. Commercial protection would more likely arise from:

• Taste-masking systems.
• Novel suspending matrices.
• Concentrated dosing formats.
• Metered-dose delivery systems.
• Unit-dose packaging.
• Preservative-free multidose systems.
• Manufacturing methods that improve redispersibility or dose uniformity.
• Combination products or new pediatric delivery technologies.

The practical patent value depends on whether the claims cover commercially necessary features. A narrow claim to a specific flavor combination may be difficult to enforce around. A broader claim covering a measurable suspension-performance profile, defined particle-size distribution, or integrated delivery system may have greater design-around value, subject to validity and enablement.

For a private-label product, freedom-to-operate review should cover the formulation manufacturer, excipient supplier, dosing-device supplier, and packaging contractor. Patent exposure may arise from a device or manufacturing process even when the ibuprofen formulation itself is unprotected.

What is the FDA regulatory status of GoodSense Children’s Ibuprofen?

Ibuprofen for temporary relief of minor aches and pains and reduction of fever is regulated under the FDA OTC monograph framework. The relevant rule establishes conditions for nonprescription internal analgesic, antipyretic, and antirheumatic products, including active ingredients, labeling, warnings, and dosage conditions [1].

Key compliance areas include:

• Active ingredient concentration.
• Age-based dosing.
• Measuring-device instructions.
• Liver and stomach warnings applicable to ibuprofen products.
• Maximum daily dose and dosing interval.
• Drug Facts labeling.
• Child-resistant packaging where required.
• Product quality and stability.
• Manufacturing under current good manufacturing practice requirements.

The product’s OTC status reduces the regulatory cost of maintaining a standard ibuprofen suspension relative to a new drug application product. It also reduces the ability to claim exclusivity based on the active ingredient.

When does GoodSense Children’s Ibuprofen lose exclusivity?

GoodSense Children’s Ibuprofen does not have a conventional prescription-drug exclusivity period. The active ingredient is available to multiple manufacturers, and standard ibuprofen oral suspensions compete in the OTC marketplace.

The relevant commercial timeline is therefore:

Event	Commercial effect
OTC monograph eligibility	Permits marketing without product-specific NDA exclusivity when conditions are met
Private-label launch	Creates retailer-level distribution and shelf presence
Competitor reformulation	Can erode differentiation
New supplier qualification	Can improve cost or reduce supply risk
Packaging or formulation redesign	Can create a new product position
New patent filing	May protect a specific formulation or delivery feature, not ibuprofen itself

A new excipient system may support intellectual-property protection, but it would not automatically create regulatory exclusivity. Patent claims and FDA compliance operate independently.

What commercial opportunities exist for GoodSense Children’s Ibuprofen?

Retail private-label expansion

The largest near-term opportunity is private-label optimization across mass retail, grocery, pharmacy, club, and e-commerce channels. Retailers can offer multiple tiers:

• Value 100 mg/5 mL suspension.
• Dye-free formulation.
• Sugar-free formulation.
• Premium flavor or improved-taste product.
• Concentrated suspension with oral syringe.
• Travel or unit-dose package.

This tiering allows the same active ingredient to support different margins without relying on a single formulation.

Pediatric dosing-device differentiation

A dosing syringe can create a measurable usability advantage. A product should minimize:

• Ambiguous dose markings.
• Syringe incompatibility with the bottle.
• Leakage.
• Excess residual volume.
• Caregiver conversion between teaspoons and milliliters.

A bottle-syringe system with an integrated adapter can reduce spills and improve dose consistency. The device may also support separate patent protection and a more defensible commercial position than a conventional suspension alone.

E-commerce and subscription sales

Children’s fever products have episodic but urgent demand. E-commerce performance depends on product availability, clear age and dose information, image clarity, and fast delivery. Multipacks and seasonal replenishment can improve basket size, but shelf-life and household overstock must be managed.

Search and merchandising terms with commercial value include:

• Children’s ibuprofen 100 mg/5 mL.
• Dye-free children’s ibuprofen.
• Sugar-free children’s ibuprofen.
• Children’s ibuprofen with syringe.
• Berry or grape ibuprofen suspension.
• Concentrated children’s ibuprofen.

Institutional and travel channels

Unit-dose or compact products may fit:

• Daycare and school first-aid programs.
• Pediatric clinics.
• Pharmacies.
• Travel kits.
• Emergency preparedness kits.
• Hospital discharge packs.

These channels value dose accuracy, tamper evidence, storage stability, and reduced contamination risk. They are less price-sensitive than conventional mass retail but require packaging and procurement validation.

What manufacturing and IP barriers affect the product?

The principal manufacturing barriers are operational rather than chemical:

• Consistent ibuprofen particle-size distribution.
• Reliable wetting and dispersion.
• Stable suspension rheology.
• Taste-masking reproducibility.
• Preservative effectiveness.
• Filling accuracy.
• Bottle and closure compatibility.
• Supply of flavor, sweetener, and suspending-agent inputs.
• Seasonal production capacity.

Seasonal fever and respiratory illness demand can create capacity pressure. A private-label sponsor should qualify more than one finished-dose manufacturer or maintain validated alternate suppliers for critical excipients and packaging components.

The most defensible IP strategy would combine formulation claims with device, packaging, and process claims. A single narrow excipient patent is unlikely to provide durable market protection in a mature OTC category.

What generic launch risks exist?

Generic entry is already structurally present because ibuprofen suspensions are widely marketed. The relevant risk is not a single Paragraph IV event against GoodSense. It is continuous substitution by other private-label and national-brand products.

Competitive risks include:

• Retailer switching to a lower-cost supplier.
• National brands increasing promotions.
• Stockouts during seasonal demand.
• Consumer migration to dye-free or sugar-free alternatives.
• Confusion from multiple ibuprofen concentrations.
• Product recalls linked to contamination, dosing devices, or stability.
• Supplier consolidation affecting cost and availability.

The best defense is a portfolio rather than one undifferentiated SKU. A retailer can protect shelf space through a standard value product while testing premium formulations with specific consumer claims.

How strong is the patent estate for GoodSense Children’s Ibuprofen?

The patent estate for a standard GoodSense pediatric ibuprofen suspension is weak in active-ingredient terms and potentially moderate for differentiated formulation or delivery technology.

IP category	Likely strength	Commercial relevance
Ibuprofen composition of matter	Very low	Mature active ingredient
Standard 100 mg/5 mL suspension	Low	Many design-around options
Specific taste-masking system	Low to moderate	Depends on claim breadth and performance
Concentrated suspension	Moderate	Greater value if linked to dose accuracy
Metered delivery device	Moderate	Can support product differentiation
Unit-dose packaging	Low to moderate	Useful commercially, often easy to design around
Manufacturing process	Moderate	Stronger if process is difficult to replicate
Brand and trade dress	Moderate	Retail and consumer value
Regulatory exclusivity	Low	OTC monograph pathway

Key Takeaways

• GoodSense Children’s Ibuprofen is a mature OTC ibuprofen suspension product with limited active-ingredient exclusivity.
• Excipient selection determines suspension stability, taste, redispersibility, microbial control, and caregiver acceptance.
• Dye-free, sugar-free, concentrated, and preservative-minimized formats offer the clearest commercial differentiation.
• A dosing syringe and integrated bottle system can improve dose accuracy and support device-related IP.
• The strongest business case is private-label portfolio segmentation across value, clean-label, premium-taste, and reduced-volume products.
• The main competitive risks are retailer switching, supply disruption, formulation substitution, and seasonal demand volatility.
• Patent protection is more credible for specialized delivery, taste-masking, process, or packaging systems than for conventional ibuprofen suspension chemistry.

FAQs

Is GoodSense Children’s Ibuprofen a generic drug?

It is an OTC private-label product containing ibuprofen. It competes with generic and branded children’s ibuprofen products under the FDA OTC monograph framework.

Can a new excipient create exclusivity for children’s ibuprofen?

A new excipient system can support patent protection for a specific formulation, but it does not automatically create FDA marketing exclusivity. Patent scope, validity, and design-around risk determine commercial value.

Is sugar-free children’s ibuprofen commercially attractive?

Yes. Sugar-free positioning can appeal to consumers managing sugar intake, but the formulation must control bitterness, mouthfeel, sweetener aftertaste, viscosity, and gastrointestinal tolerance.

Would a concentrated ibuprofen suspension improve margins?

It can reduce liquid volume, packaging weight, and shipping cost. Margin improvement depends on the added cost of taste masking, specialized dosing devices, stability work, and packaging safeguards against concentration errors.

What is the most valuable excipient innovation for pediatric ibuprofen?

A system that combines effective bitterness reduction with stable suspension performance and accurate syringe dosing has the strongest commercial potential. It addresses adherence, safety, and product differentiation at the same time.

References

1. U.S. Food and Drug Administration. (2023). 21 C.F.R. § 341: 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). Drug facts labeling for nonprescription human drug products. FDA.

3. United States Pharmacopeia. (2024). USP–NF general chapter <795>: Pharmaceutical compounding, nonsterile preparations. United States Pharmacopeial Convention.

4. U.S. Food and Drug Administration. (2022). Product quality and manufacturing standards for over-the-counter drug products. FDA.

5. DailyMed. (n.d.). Ibuprofen oral suspension product labeling. National Library of Medicine.