List of Excipients in Branded Drug CHILDRENS IBUPROFEN 100

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Generic Drugs Containing CHILDRENS IBUPROFEN 100

Company	Ingredient	NDC	Excipient
Walgreen Company	ibuprofen	0363-0806	ANHYDROUS CITRIC ACID
Walgreen Company	ibuprofen	0363-0806	GLYCERIN
Walgreen Company	ibuprofen	0363-0806	HIGH FRUCTOSE CORN SYRUP
Walgreen Company	ibuprofen	0363-0806	HYPROMELLOSE
Walgreen Company	ibuprofen	0363-0806	POLYSORBATE 80
Walgreen Company	ibuprofen	0363-0806	SODIUM BENZOATE

What are the Most Frequently-Used Excipients in CHILDRENS IBUPROFEN 100?

# Of NDCs	Excipient
2	ACESULFAME POTASSIUM
2	AMMONIUM GLYCYRRHIZATE
1	ANHYDROUS CITRIC ACID
2	ASPARTAME
2	CARNAUBA WAX
2	CROSCARMELLOSE SODIUM

Children’s Ibuprofen 100 mg/5 mL: Excipient Strategy, Regulatory Status, Patent Exposure, and Commercial Opportunities

Last updated: September 24, 2026

Children’s ibuprofen 100 mg/5 mL is an established over-the-counter oral suspension used for temporary reduction of fever and relief of minor aches and pains in children. The active ingredient is broadly available, generally protected by formulation execution rather than composition-of-matter patents. Commercial opportunities center on palatability, dosing accuracy, preservative systems, sugar-free positioning, packaging, private-label supply, and differentiated delivery formats.

What is Children’s Ibuprofen 100 mg/5 mL?

Children’s ibuprofen 100 mg/5 mL is an oral liquid containing 20 mg/mL of ibuprofen. It is usually marketed for children age 2 years and older, with dosing based on age and weight. Products may be sold under branded, store-brand, and generic labels.

Attribute	Typical product profile
Active ingredient	Ibuprofen
Strength	100 mg/5 mL
Concentration	20 mg/mL
Dosage form	Oral suspension
Regulatory category	OTC drug
Primary uses	Fever reduction and temporary relief of minor aches and pains
Common packaging	4 fl oz, 6 fl oz, or 8 fl oz bottle
Measuring device	Oral syringe or dosing cup
Primary competitors	Children’s acetaminophen, children’s naproxen where applicable, branded ibuprofen products, store brands
Typical buyer	Parent, caregiver, pharmacy, mass merchant, grocery retailer

The product is a suspension because ibuprofen has limited water solubility. The formulation must keep the active ingredient uniformly dispersed between doses and permit accurate withdrawal through a dosing syringe or cup.

What is the FDA regulatory status of Children’s Ibuprofen 100 mg/5 mL?

Children’s ibuprofen oral suspension is generally regulated under the FDA’s OTC internal analgesic, antipyretic, and antirheumatic monograph framework, subject to applicable labeling, dosing, active-ingredient, and manufacturing requirements. The relevant regulatory framework is codified principally at 21 C.F.R. Part 343, with general drug manufacturing and labeling obligations under the Federal Food, Drug, and Cosmetic Act (FDA, 2024a; FDA, 2024b).

FDA monograph-based OTC products do not require an individual approved New Drug Application when the formulation and labeling comply with the applicable monograph conditions. A company can commercialize a compliant product through an OTC monograph pathway, subject to establishment registration, listing, current good manufacturing practice, adverse-event reporting, and labeling requirements.

Is Children’s Ibuprofen listed in the Orange Book?

A standard OTC monograph product is generally not evaluated through the same Orange Book approval and patent-listing structure as an NDA product. The Orange Book primarily identifies approved prescription drugs and certain approved nonprescription products associated with approved applications.

As a result, a compliant Children’s Ibuprofen 100 mg/5 mL product normally does not have an Orange Book patent estate comparable to a prescription product. Commercial competitors typically do not file Paragraph IV certifications against one another solely for a monograph-compliant ibuprofen suspension.

What excipients are used in Children’s Ibuprofen suspension?

The excipient system varies by manufacturer, but commercial products commonly include:

• Purified water
• Suspending agents
• Wetting agents
• Sweeteners
• Flavoring agents
• Buffering agents
• Preservatives
• Colorants
• Chelating agents
• Viscosity modifiers

The key formulation challenge is balancing physical stability, taste, pourability, dose uniformity, microbial control, and consumer acceptance.

Which suspending agents are commercially useful?

Potential suspending and rheology systems include xanthan gum, microcrystalline cellulose with carboxymethylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, and other pharmaceutical-grade polymers.

Xanthan gum can provide strong suspension performance at relatively low concentrations. It may produce excessive thickness or stringiness if the system is overbuilt. Microcrystalline cellulose and carboxymethylcellulose combinations can produce a more structured suspension with acceptable pour characteristics, but they require careful hydration and processing control.

The optimal system should be evaluated for:

• Sedimentation rate
• Redispersibility after storage
• Dose uniformity at the beginning, middle, and end of bottle use
• Syringe withdrawal force
• Pourability
• Viscosity across temperature ranges
• Compatibility with preservatives and flavors

The best commercial formulation is not necessarily the one with the highest viscosity. A suspension that resists sedimentation but cannot be accurately withdrawn through a syringe creates a dosing and consumer-use problem.

Which sweeteners and flavors create commercial differentiation?

Sucrose can improve taste but creates sugar-content concerns and may be unsuitable for some consumer segments. Sorbitol, glycerin, sucralose, saccharin sodium, and other sweetener systems can support sugar-free or reduced-sugar claims, subject to labeling and formulation review.

Ibuprofen has a characteristic bitter taste. Flavor masking is therefore a major commercial variable. Berry, grape, bubble gum, and fruit combinations are common positioning options. Taste-masking systems may combine high-intensity sweeteners, flavors, bitterness suppressors, and viscosity control.

A successful flavor system must remain stable during shelf life. Flavor loss, oxidation, interaction with preservatives, or changes in viscosity can reduce consumer acceptance even when the active ingredient remains within specification.

What excipient strategy offers the strongest commercial opportunity?

The strongest opportunity is a differentiated liquid suspension that improves administration without changing the established 100 mg/5 mL strength.

Sugar-free and dye-free formulations

Parents increasingly look for products labeled sugar-free, alcohol-free, and dye-free. These claims can support premium pricing and retailer placement. Dye-free products also reduce concerns among consumers who prefer fewer color additives.

A sugar-free product must retain acceptable mouthfeel and taste. Polyols can create cooling effects, gastrointestinal tolerance concerns at higher levels, or altered viscosity. The product should be assessed for pediatric acceptability rather than relying solely on adult sensory panels.

Preservative strategy

Aqueous pediatric suspensions generally require microbial-control measures unless the packaging and formulation support a validated alternative. Preservatives such as sodium benzoate or potassium sorbate may be used depending on pH, concentration, and compatibility.

Preservative selection should consider:

• pH dependence
• Antimicrobial effectiveness
• Flavor impact
• Compatibility with polymers and surfactants
• Container interaction
• Pediatric exposure
• Regulatory acceptability in target markets

A preservative-free multidose product may be commercially attractive but requires stronger packaging, validated microbiological control, or a different presentation such as unit-dose sachets or single-use cups.

High-dose accuracy

The product should support accurate dosing at the labeled dose volumes. An oral syringe generally offers better accuracy than a dosing cup, especially for smaller volumes. A commercial product can differentiate through a low-resistance syringe, an integrated adapter, clear graduation marks, and a bottle design that reduces leakage.

The device and bottle are part of the product strategy. A strong formulation paired with an inaccurate or difficult-to-use measuring system creates avoidable consumer risk.

What formulations are protected by patents?

The active ingredient, ibuprofen, is a mature generic molecule with no meaningful composition-of-matter exclusivity for a standard pediatric suspension. Basic formulations using conventional excipients are unlikely to support broad, durable patent protection.

Potentially protectable subject matter can include:

• A defined excipient ratio that improves physical stability
• A specific taste-masking system
• A low-viscosity suspension with improved redispersibility
• A preservative-free multidose package
• A unit-dose delivery system
• A child-resistant and senior-friendly closure combination
• A syringe-bottle interface
• A manufacturing process that improves particle-size distribution
• A formulation with reduced sedimentation after repeated opening
• A formulation optimized for a particular pH or flavor system

Patent strength depends on claim breadth, unexpected performance data, freedom-to-operate analysis, and whether competitors can substitute another polymer, sweetener, flavor, or packaging configuration.

A patent directed only to a narrow combination of common excipients may have limited blocking power. Trade secrets covering processing order, homogenization conditions, particle-size control, or flavor integration may provide stronger practical protection than a narrow formulation patent.

When does Children’s Ibuprofen lose exclusivity?

Children’s Ibuprofen 100 mg/5 mL has no single loss-of-exclusivity date because the product category is already generic and generally available through the OTC monograph system. Brand-specific market protection may arise from trademarks, retailer contracts, formulation patents, packaging rights, or supply agreements rather than drug exclusivity.

Protection type	Typical status
Ibuprofen composition patent	Expired or not relevant to current OTC products
Standard suspension formulation	Generally unprotected or weakly protected
OTC monograph pathway	Open to compliant manufacturers
Trademark	Brand-specific and renewable
Formulation patent	Possible but narrow and product-specific
Packaging patent	Possible, usually narrow
Private-label agreement	Contractual and time-limited
Market exclusivity	Usually based on brand, distribution, or retail position

Are there Paragraph IV challenges or biosimilar risks?

Paragraph IV litigation

Paragraph IV litigation is generally not the principal competitive risk for a standard Children’s Ibuprofen 100 mg/5 mL product because the product is ordinarily marketed under an OTC monograph framework rather than as a new prescription drug with Orange Book-listed patents.

The relevant risks are more likely to involve:

• FDA inspection findings
• Product recalls
• Labeling disputes
• Trademark litigation
• Trade dress disputes
• Contract manufacturing disputes
• Patent claims covering a differentiated device or formulation
• Consumer class actions involving dosing, contamination, or labeling

Biosimilar risk

Biosimilar risk is not applicable. Ibuprofen is a small-molecule drug, not a biologic. Competitive entry occurs through generic and private-label manufacturers rather than biosimilar sponsors.

Which companies compete in the Children’s Ibuprofen market?

Competition includes branded manufacturers, generic drug companies, contract manufacturers, pharmacy chains, mass retailers, and grocery retailers.

Representative commercial categories include:

Competitor type	Commercial strategy
Branded pediatric analgesic company	National advertising, flavor recognition, premium pricing
Generic manufacturer	Low cost, pharmacy and wholesale distribution
Retail private label	Shelf-price advantage and retailer control
Contract manufacturer	Flexible supply, multiple labels, lower development burden
E-commerce seller	Multipacks, subscription purchasing, convenience
Specialty pediatric brand	Dye-free, sugar-free, clean-label positioning

Private-label supply is particularly attractive because the active ingredient and dosage strength are standardized. A manufacturer can use a common validated platform formulation while adapting flavor, color, label, bottle size, and packaging for different retailers.

What commercial opportunities exist in Children’s Ibuprofen excipients?

The most practical opportunities are formulation and packaging improvements that reduce use errors or increase repeat purchase.

Premium pediatric suspension

A premium product could combine:

• Dye-free formulation
• Sugar-free formulation
• Improved berry or fruit flavor
• Oral syringe included in every package
• Low-residue suspension
• Easy-redispersion performance
• Tamper-evident and child-resistant packaging
• Smaller bottle options for travel and occasional use

Unit-dose packaging

Single-use cups, sachets, or premeasured oral doses could reduce measurement errors and improve portability. The main challenges are fill-volume accuracy, packaging cost, stability, waste, and child-resistant presentation.

Concentrated presentations

A higher concentration could reduce dose volume, but concentration changes create substantial medication-error risk. A product intended for broad retail use should avoid concentration confusion with existing 100 mg/5 mL products unless labeling, dosing devices, and distribution are carefully controlled.

Hospital and institutional supply

Hospitals, urgent-care centers, schools, and pediatric clinics may value unit-dose packaging, barcode compatibility, tamper evidence, and standardized dosing devices. Institutional procurement can support larger-volume contracts but usually imposes stricter documentation and supply-continuity requirements.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are moderate rather than fundamental. Ibuprofen is widely available, and conventional suspension equipment is common. The main technical barriers are process consistency and product performance.

Critical manufacturing controls include:

• Active-particle size and distribution
• Wetting and deagglomeration
• Polymer hydration
• Mixing sequence
• Homogenization energy
• Air incorporation
• Fill-volume accuracy
• Microbial control
• Redispersibility after storage
• Container-closure compatibility

A formulation can pass initial release testing and still perform poorly after temperature cycling, long-term storage, or repeated opening. Stability studies should monitor assay, degradation products, pH, viscosity, microbial quality, sedimentation, redispersibility, flavor, color, and dose uniformity.

Geographic protection is limited for the basic product. A formulation patent may be filed in the United States, Europe, Japan, Canada, Australia, and other major markets, but enforcement value will depend on whether the claims cover a commercially important feature. Manufacturing-process claims may be more difficult to enforce when production occurs outside the covered jurisdiction.

What patent litigation affects Children’s Ibuprofen?

There is no widely recognized patent-litigation pattern comparable to litigation involving high-value prescription drugs. The standard product is exposed primarily to non-patent risks:

• Product liability claims
• Manufacturing defects
• Contamination recalls
• Incorrect dosing-device claims
• Labeling and advertising disputes
• Trademark and trade dress conflicts
• Retail supply disputes

A differentiated formulation or delivery device could create patent risk, but that risk would attach to the specific patented technology rather than to ibuprofen itself.

How strong is the patent estate for Children’s Ibuprofen 100 mg/5 mL?

The patent estate is weak for the basic product and potentially moderate for a differentiated formulation or delivery system.

Product element	Patent position
Ibuprofen active ingredient	Weak; mature generic molecule
100 mg/5 mL strength	Weak; standard market presentation
Conventional suspension	Weak unless supported by unexpected technical results
Taste-masking system	Moderate if claims are narrow and data-supported
Preservative-free system	Moderate, depending on formulation and package
Dosing syringe and adapter	Moderate for specific structural designs
Manufacturing process	Moderate to strong if technically distinctive
Brand and trade dress	Potentially strong but separate from patent rights
Supply platform	Protected mainly by know-how and contracts

What revenue exposure and launch scenarios exist?

Revenue exposure is concentrated in volume rather than exclusivity. A branded product can lose share quickly if a retailer introduces a lower-priced private label or if a competitor wins a national distribution agreement.

Launch scenario	Expected commercial effect
Basic compliant suspension	Fast entry but intense price competition
Dye-free or sugar-free product	Potential premium positioning
Better-tasting formulation	Improved repeat purchase and caregiver preference
Unit-dose product	Higher manufacturing cost but institutional opportunity
Integrated syringe system	Differentiation through dosing convenience
Private-label platform	High volume with lower per-unit margin
Premium branded product	Higher margin but greater marketing expense

The most attractive business model is often a platform approach: one validated ibuprofen suspension base with multiple flavors, bottle sizes, labels, and retailer configurations. This reduces development cost while preserving commercial flexibility.

Key Takeaways

• Children’s Ibuprofen 100 mg/5 mL is a mature OTC product with broad generic availability.
• The product is generally regulated under the FDA OTC monograph framework rather than through prescription-drug exclusivity.
• Standard ibuprofen suspension products usually have limited patent protection and no meaningful Orange Book exclusivity.
• Excipient value is concentrated in suspension stability, taste masking, sugar-free and dye-free positioning, preservative control, and dosing accuracy.
• Oral syringes, bottle adapters, unit-dose packages, and child-resistant closures create practical differentiation.
• Biosimilar risk does not apply because ibuprofen is a small-molecule drug.
• Paragraph IV litigation is generally not the principal competitive issue.
• The strongest commercial opportunity is a scalable formulation platform serving branded, generic, private-label, and institutional channels.
• Manufacturing know-how, packaging design, trademarks, and retailer contracts may provide greater commercial protection than a narrow formulation patent.

FAQs

Is Children’s Ibuprofen 100 mg/5 mL the same as infant ibuprofen?

The active ingredient and concentration may be the same in some products, but labeling, dosing instructions, packaging, and intended age ranges can differ. Product-specific labeling controls.

Can a manufacturer sell Children’s Ibuprofen without an NDA?

A compliant product may be marketed under the applicable OTC monograph pathway, subject to FDA registration, listing, labeling, manufacturing, and other regulatory requirements.

Is ibuprofen suspension patentable?

A new formulation may be patentable if it satisfies novelty, nonobviousness, and written-description requirements. Conventional combinations of common excipients face a higher risk of narrow or invalid claims.

Which excipient best prevents sedimentation in pediatric ibuprofen?

No single excipient is universally optimal. Xanthan gum and microcrystalline-cellulose/carboxymethylcellulose systems are common candidates, but performance depends on particle size, pH, solids loading, processing, and desired syringe behavior.

Can Children’s Ibuprofen be sold as a sugar-free product?

Yes. Sugar-free formulations can use alternative sweeteners and polyols, provided the formulation performs acceptably and the labeling complies with FDA requirements and applicable claims standards.

References

1. Code of Federal Regulations. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. U.S. Government Publishing Office.

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

3. U.S. Food and Drug Administration. (2024b). Drug Facts label requirements. https://www.fda.gov/drugs/drug-information-consumers/drug-facts-label

4. U.S. Food and Drug Administration. (2024c). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Food and Drug Administration. (2024d). Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. Part 211. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211