List of Excipients in Branded Drug WALPROFEN CONGESTION RELIEF AND PAIN

Generic Drugs Containing WALPROFEN CONGESTION RELIEF AND PAIN

Company	Ingredient	NDC	Excipient
Walgreen Company	ibuprofen, phenylephrine hcl	0363-0158	ACESULFAME POTASSIUM
Walgreen Company	ibuprofen, phenylephrine hcl	0363-0158	CELLULOSE, MICROCRYSTALLINE
Walgreen Company	ibuprofen, phenylephrine hcl	0363-0158	CROSCARMELLOSE SODIUM
Walgreen Company	ibuprofen, phenylephrine hcl	0363-0158	FD&C BLUE NO. 2

What are the Most Frequently-Used Excipients in WALPROFEN CONGESTION RELIEF AND PAIN?

# Of NDCs	Excipient
1	ACESULFAME POTASSIUM
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 2

Wal-Profen Congestion Relief and Pain: Excipient Strategy, Regulatory Risk, and Commercial Opportunities

Last updated: September 23, 2026

Wal-Profen Congestion Relief and Pain is an over-the-counter combination product generally labeled with ibuprofen 200 mg for pain and fever and phenylephrine hydrochloride 10 mg for nasal congestion. Its commercial position depends more on OTC monograph compliance, formulation performance, retail economics, and the future of oral phenylephrine than on patent exclusivity. The strongest opportunities are lower-cost caplet manufacture, improved swallowability, differentiated delivery formats, and reformulation around decongestant ingredients with stronger regulatory support.

What is Wal-Profen Congestion Relief and Pain?

Wal-Profen Congestion Relief and Pain is a nonprescription oral combination of an NSAID analgesic and an oral nasal decongestant.

Product element	Commercial relevance
Ibuprofen	Provides analgesic, antipyretic and anti-inflammatory activity
Phenylephrine hydrochloride	Provides the labeled oral nasal-decongestant function
Dosage form	Typically an immediate-release caplet or tablet
Regulatory route	OTC monograph or monograph-aligned NDA pathway, depending on the marketed presentation
Likely buyer	Retail pharmacy, mass merchant, club, grocery and e-commerce consumer
Primary competitors	Advil Cold & Sinus, generic ibuprofen/phenylephrine products, acetaminophen/decongestant combinations and single-ingredient products

The formulation is commercially attractive because it combines two familiar OTC actives in one unit dose. The product also faces a material regulatory issue: FDA concluded in a proposed order that oral phenylephrine is not effective as a nasal decongestant at the marketed oral dose. The proposed action could affect future formulations, labeling and product positioning. The FDA action did not question the effectiveness of ibuprofen for pain or fever. (FDA, 2024a)

What excipients are likely to be used in Wal-Profen tablets?

Public labeling should control the exact inactive-ingredient assessment for a particular National Drug Code and lot. A conventional immediate-release ibuprofen/phenylephrine caplet would normally use excipients from the following functional groups:

Excipient function	Common candidates	Strategic purpose
Diluent	Microcrystalline cellulose, starch, lactose or dibasic calcium phosphate	Adds bulk and improves compression
Binder	Povidone, pregelatinized starch or hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone or sodium starch glycolate	Supports rapid tablet breakup
Lubricant	Magnesium stearate, stearic acid or sodium stearyl fumarate	Reduces sticking and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow
Coating polymer	Hypromellose or polyvinyl alcohol	Improves swallowability and protects the tablet
Plasticizer	Polyethylene glycol or triacetin	Supports coating flexibility
Opacifier or colorant	Titanium dioxide or approved FD&C colorants	Provides appearance and product identification
Processing aid	Purified water or alcohol-based granulation solvent	Used during manufacturing and removed during drying

The key technical constraint is the combination of ibuprofen and phenylephrine hydrochloride. Ibuprofen is a relatively high-dose, poorly water-soluble active. Phenylephrine hydrochloride is lower dose, water soluble and sensitive to blend-uniformity risk because it represents a small fraction of the tablet mass. The excipient system must therefore support uniform distribution of phenylephrine without slowing ibuprofen disintegration.

How should the excipient system be designed?

A robust platform would use either direct compression with engineered grades or a segregated granulation process.

Direct compression has the lowest process complexity and can support low-cost private-label production. Its risks are powder segregation, poor flow and inconsistent phenylephrine distribution. A carrier system using microcrystalline cellulose, pregelatinized starch and colloidal silicon dioxide can improve flow, but blend-uniformity validation remains essential.

Wet granulation can reduce segregation and improve content uniformity. It increases equipment, drying and validation costs. Excessive granulation or hydrophobic lubrication can delay disintegration and dissolution, particularly for ibuprofen.

A practical development target is:

1. Uniform phenylephrine distribution at the low drug load.
2. Rapid disintegration consistent with an immediate-release product.
3. Dissolution performance that is robust across manufacturing scale.
4. Sufficient hardness for high-volume packaging and transport.
5. A low-moisture process where required by active stability.
6. A coating that improves swallowability without creating a modified-release profile.

Excipient selection should be justified by compendial quality, supplier continuity, allergen status, geographic availability and cost. Novel excipients offer little commercial benefit in a mature OTC category unless they materially improve stability, dose uniformity or dosage-form performance.

What formulation patents protect Wal-Profen Congestion Relief and Pain?

The branded product is unlikely to have meaningful product-specific patent protection based solely on the product name. Ibuprofen and phenylephrine hydrochloride are long-established active ingredients. A conventional immediate-release combination tablet normally has limited patentability unless it includes a novel ratio, release profile, delivery system, stability solution or manufacturing process.

The relevant IP categories are:

IP category	Likely strength
Ibuprofen active ingredient	Very low; long-established compound
Phenylephrine hydrochloride active ingredient	Very low; long-established compound
Conventional tablet excipients	Very low
Standard immediate-release combination	Low
Novel formulation or coating	Moderate only if supported by unexpected performance
Manufacturing process	Moderate as a trade secret; patent strength depends on process specificity
Brand and packaging	Trademark and trade-dress value, not drug patent exclusivity
Product-specific method of use	Low for conventional OTC symptom relief

The main barriers are regulatory compliance, manufacturing scale, retail placement, brand recognition and supply-chain economics. These barriers can be commercially significant even when patent barriers are weak.

What is the Orange Book status of Wal-Profen?

Wal-Profen Congestion Relief and Pain is generally an OTC product rather than an Orange Book-listed prescription drug. The Orange Book primarily identifies approved prescription drug products and related patent and exclusivity information. A conventional OTC monograph product does not receive Orange Book patent protection merely because it is sold under a private-label brand. (FDA, 2024b)

There is therefore no ordinary Orange Book Paragraph IV pathway directed specifically at the Wal-Profen brand. A competing company would normally enter by:

• Marketing a product under the applicable OTC monograph;
• Filing an abbreviated or full application if the product falls outside monograph conditions;
• Using an authorized private-label or contract-manufacturing structure; or
• Launching a therapeutically similar product with different branding and packaging.

When does Wal-Profen lose exclusivity?

Wal-Profen does not appear to depend on a conventional patent or regulatory exclusivity period. Its market protection is primarily commercial.

Protection type	Expected position
New chemical entity exclusivity	Not applicable
Prescription Orange Book exclusivity	Generally not applicable
Paragraph IV exposure	Not applicable to the ordinary OTC monograph product
OTC monograph protection	Applies only while the formulation and labeling comply with applicable requirements
Trademark protection	Continues subject to registration and use
Retail exclusivity	Contractual and channel-specific
Formulation know-how	Potentially indefinite as a trade secret

A competitor can generally launch a compliant ibuprofen/phenylephrine product without waiting for a patent expiration date. The competitor still must satisfy active-ingredient, labeling, manufacturing, quality and registration requirements.

How does the FDA phenylephrine action affect commercial opportunities?

FDA proposed removing oral phenylephrine as an acceptable OTC nasal-decongestant active ingredient after reviewing efficacy data. The proposed order focused on effectiveness, not safety. If finalized, manufacturers would face significant pressure to reformulate, relabel or discontinue oral phenylephrine combination products. (FDA, 2024a)

This creates four commercial scenarios:

Scenario	Effect on Wal-Profen-type products
Phenylephrine remains temporarily marketable	Existing products continue, but demand and retailer confidence may weaken
FDA finalizes removal with a transition period	Reformulation and inventory conversion become necessary
Manufacturers switch to pseudoephedrine	Regulatory and supply-chain complexity increase because of behind-the-counter controls
Manufacturers remove the decongestant	Product becomes an ibuprofen pain-and-fever product with less differentiated positioning

The regulatory risk is concentrated in the decongestant component. It does not eliminate the commercial value of ibuprofen or the broader cold-and-flu category.

What excipient reformulation opportunities exist?

Ibuprofen-only reformulation

Removing phenylephrine allows a simpler formulation with lower blend-uniformity risk. The product could be positioned for pain and fever without a decongestant claim. Manufacturing may become cheaper because the tablet can use a simpler blend and fewer analytical controls for low-dose distribution.

The commercial disadvantage is reduced basket value and weaker relevance for consumers seeking multi-symptom relief.

Pseudoephedrine combination

Ibuprofen/pseudoephedrine is a clinically recognizable alternative for pain and congestion. It may command stronger consumer demand than oral phenylephrine, but pseudoephedrine is subject to federal and state sales controls, purchase limits, recordkeeping requirements and retailer-specific policies under the Combat Methamphetamine Epidemic Act. (U.S. Drug Enforcement Administration, n.d.)

Excipient strategy would remain conventional. The principal barriers would be controlled-sales logistics, demand forecasting, compliance infrastructure and retailer authorization.

Liquid or softgel formats

Liquid ibuprofen/decongestant products can improve swallowability and support pediatric or adult segments, subject to appropriate labeling and age restrictions. They create greater stability, taste-masking, preservative and packaging demands.

Softgels can improve consumer perception and swallowing for adults. They require compatible liquid fills, shell stability, oxygen control and specialized equipment. A softgel platform may create more defensible manufacturing know-how than a standard compressed caplet, but the category remains vulnerable to fast-following competition.

Rapid-disintegrating or smaller caplets

A smaller caplet, multilayer tablet or rapid-disintegrating format could address swallowability and onset expectations. The formulation must avoid compromising dose uniformity or dissolution. A smaller dosage form may require higher-density excipients, stronger compaction or a different unit-dose configuration.

What manufacturing and IP barriers affect the product?

The principal manufacturing barriers are operational rather than patent-based.

Content uniformity

Phenylephrine is present at a much lower dose than ibuprofen. Segregation during blending, transfer and filling can create out-of-specification risk. Ordered mixing, granulation or engineered excipients may reduce this risk.

Dissolution

Ibuprofen’s low aqueous solubility makes dissolution sensitive to particle size, wetting, compression force, lubricant level and disintegrant selection. A formulation that passes content uniformity can still fail dissolution if the tablet becomes too hard or overly hydrophobic.

Coating and packaging

Film coating improves appearance and swallowing but increases processing time and can affect moisture protection. High-throughput products require consistent coating weight, low defect rates and packaging that limits exposure to humidity.

Supplier qualification

Private-label manufacturers should qualify at least two sources for critical excipients where feasible. Microcrystalline cellulose, disintegrants, magnesium stearate and coating polymers can affect tablet performance materially. Changes may require comparative dissolution and stability work even when the excipient is pharmacopeial grade.

Process parameters, blend order, lubrication time, granulation endpoint and coating conditions can be retained as trade secrets. Those controls may provide greater practical protection than a formulation patent.

Which companies are challenging the product category?

Wal-Profen competes in a fragmented OTC field rather than a patent-controlled market. Relevant competitive groups include:

• Branded ibuprofen products such as Advil;
• Branded cold-and-sinus products using ibuprofen and pseudoephedrine;
• Store-brand products sold by Walgreens, Walmart, CVS, Rite Aid, Kroger and other retailers;
• Generic manufacturers and contract manufacturers;
• Acetaminophen-based cold-and-flu products;
• Single-ingredient ibuprofen and decongestant products.

Competition is based on unit price, count size, retailer margin, shelf placement, search visibility, consumer familiarity and supply reliability. A private-label manufacturer can compete effectively with a conventional caplet if it maintains low defect rates and reliable fill rates.

What generic entry risks exist?

Generic or private-label entry risk is high because a conventional OTC formulation has limited exclusivity. The most realistic launch routes are monograph-compliant products, not Paragraph IV challenges.

A new entrant could compete through:

1. A lower unit price.
2. Larger count bottles.
3. Club-pack or multi-pack formats.
4. A smaller caplet.
5. A softgel or liquid dosage form.
6. A pseudoephedrine-based alternative.
7. An ibuprofen-only product after oral phenylephrine reformulation.
8. E-commerce bundles with related cold products.

The risk to an incumbent is greatest when the brand has no meaningful formulation differentiation and the retailer controls shelf placement.

What licensing deals and commercial partnerships are relevant?

The most likely deal structures are supply and commercialization agreements rather than patent licenses. These may include:

Deal structure	Commercial use
Contract manufacturing agreement	Produces tablets, softgels or liquids for a retailer
Private-label supply agreement	Gives a retailer a branded store product
Active-ingredient supply agreement	Secures ibuprofen or decongestant supply
Packaging and fulfillment agreement	Supports multi-SKU retail distribution
Brand licensing	Expands a recognized consumer-health brand into a retailer channel
Reformulation collaboration	Replaces or removes phenylephrine after regulatory action

A formulation patent license would be less likely unless the product uses a protected softgel, modified-release platform, taste-masking system or specialized manufacturing process.

How strong is the patent estate for Wal-Profen?

The apparent patent estate is weak for a conventional immediate-release product. The product’s defensibility is likely based on:

• Trademark rights;
• Retail distribution;
• Cost-efficient manufacturing;
• Supply continuity;
• Packaging and merchandising;
• Consumer familiarity;
• Internal process controls; and
• Potential retailer exclusivity.

A stronger IP position could be developed around a technically differentiated dosage form, but any patent strategy would need to avoid claiming ordinary excipient combinations or predictable substitutions. Claims directed to a specific performance result, manufacturing sequence or stability profile would require substantial supporting data.

Key Takeaways

• Wal-Profen Congestion Relief and Pain is generally an ibuprofen and phenylephrine hydrochloride OTC combination.
• Its commercial protection is not expected to come from Orange Book patents or Paragraph IV litigation.
• Conventional excipients can support a low-cost immediate-release caplet, but phenylephrine content uniformity and ibuprofen dissolution require careful process control.
• The largest strategic risk is FDA’s proposed action against oral phenylephrine effectiveness.
• Ibuprofen-only, pseudoephedrine, softgel, liquid and smaller-caplet formats are the main reformulation opportunities.
• Manufacturing know-how, supply reliability and retail execution are more important than conventional formulation patents.
• A transition away from oral phenylephrine could create licensing, contract-manufacturing and private-label opportunities.

FAQs

Is Wal-Profen Congestion Relief and Pain protected by a drug patent?

A conventional Wal-Profen OTC combination is unlikely to have meaningful patent exclusivity based on the active ingredients or ordinary tablet excipients. Commercial protection is more likely to arise from trademarks, retail contracts and manufacturing know-how.

Can a company launch a generic version of Wal-Profen?

Yes. A competitor can generally market a compliant OTC alternative without waiting for an Orange Book patent expiration, provided the formulation, labeling, manufacturing and quality systems satisfy applicable FDA requirements.

Will FDA ban phenylephrine in Wal-Profen?

FDA proposed removing oral phenylephrine as an OTC nasal-decongestant ingredient after determining that available data did not establish effectiveness at the marketed oral dose. The final commercial effect depends on the agency’s final action and any transition provisions. (FDA, 2024a)

Which excipient is most important for ibuprofen combination tablets?

The most important choice is usually the combined disintegrant, binder and lubricant system. These excipients affect tablet strength, dissolution, manufacturability and release of poorly soluble ibuprofen.

Is pseudoephedrine a stronger commercial alternative to phenylephrine?

Pseudoephedrine has a stronger established role in oral decongestant products, but its commercial use carries behind-the-counter controls, purchase limits and added retailer compliance requirements. It is not a simple one-for-one regulatory substitution.

References

1. U.S. Food and Drug Administration. (2024a). FDA proposes ending use of oral phenylephrine as an OTC monograph nasal decongestant active ingredient. https://www.fda.gov

2. U.S. Food and Drug Administration. (2024b). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov

3. U.S. Food and Drug Administration. (n.d.). Over-the-counter monograph drugs. https://www.fda.gov

4. U.S. Food and Drug Administration. (n.d.). DailyMed: Current medication labels. National Library of Medicine. https://dailymed.nlm.nih.gov

5. U.S. Drug Enforcement Administration. (n.d.). Combat Methamphetamine Epidemic Act requirements for retail sellers of scheduled listed chemical products. https://www.deadiversion.usdoj.gov