List of Excipients in Branded Drug BASIC CARE ALLERGY RELIEF NASAL

Generic Drugs Containing BASIC CARE ALLERGY RELIEF NASAL

Company	Ingredient	NDC	Excipient
L Perrigo Company	fluticasone propionate	0113-7117	BENZALKONIUM CHLORIDE
L Perrigo Company	fluticasone propionate	0113-7117	CARBOXYMETHYLCELLULOSE SODIUM
L Perrigo Company	fluticasone propionate	0113-7117	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	fluticasone propionate	0113-7117	DEXTROSE
L Perrigo Company	fluticasone propionate	0113-7117	PHENYLETHYL ALCOHOL
L Perrigo Company	fluticasone propionate	0113-7117	POLYSORBATE 80

What are the Most Frequently-Used Excipients in BASIC CARE ALLERGY RELIEF NASAL?

# Of NDCs	Excipient
3	BENZALKONIUM CHLORIDE
3	CARBOXYMETHYLCELLULOSE SODIUM
3	CELLULOSE, MICROCRYSTALLINE
3	DEXTROSE
3	PHENYLETHYL ALCOHOL
3	POLYSORBATE 80

BASIC CARE ALLERGY RELIEF NASAL: Excipient Strategy, Patent Position and Commercial Opportunities

Last updated: August 9, 2026

Basic Care Allergy Relief Nasal is an over-the-counter intranasal corticosteroid product marketed as a store-brand alternative to Flonase Allergy Relief. The product’s active ingredient is fluticasone propionate, typically delivered at 50 micrograms per spray. Its commercial position is driven by low-cost substitution, retail distribution and product familiarity rather than active-ingredient exclusivity.

The main excipient opportunity is not a conventional composition patent. It is improvement of suspension stability, spray performance, preservative strategy, sensory profile, packaging and manufacturing efficiency. The product is likely exposed to limited patent risk because fluticasone propionate nasal-spray composition and use patents have largely expired. Differentiation can come from a better device, preservative-free presentation, lower-drip formulation, pediatric usability or a licensed private-label platform.

What is Basic Care Allergy Relief Nasal?

Basic Care Allergy Relief Nasal is an OTC nasal spray used for temporary relief of symptoms associated with seasonal and perennial allergic rhinitis. The product is generally sold in a 120-spray package and is positioned as an economical equivalent to branded fluticasone propionate nasal spray.

Active ingredient and dosage form

Attribute	Product profile
Brand	Basic Care Allergy Relief Nasal
Therapeutic category	Intranasal corticosteroid
Active ingredient	Fluticasone propionate
Typical strength	50 mcg per spray
Dosage form	Aqueous nasal spray suspension
Primary indication	Allergic rhinitis
Regulatory category	OTC drug
Reference commercial product	Flonase Allergy Relief
Likely retail channel	Private-label and e-commerce retail
Primary commercial value	Price-led substitution and distribution

The product is an aqueous suspension rather than a simple solution. Fluticasone propionate has low aqueous solubility, so particle-size control, suspension uniformity and dose reproducibility are central to product quality.

The marketed inactive-ingredient profile for fluticasone propionate nasal sprays commonly includes microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, polysorbate 80, benzalkonium chloride, phenethyl alcohol and purified water. The exact label should be confirmed against the current product package and DailyMed record before making a regulatory or sourcing decision.[1]

What excipients are used in Basic Care Allergy Relief Nasal?

The excipient system has five functional jobs: suspend the active ingredient, maintain physical stability, preserve the multidose container, control wetting and redispersion, and provide an acceptable nasal sensory profile.

Excipient or excipient system	Primary function	Commercial relevance
Microcrystalline cellulose	Suspending and structuring agent	Supports uniform dose delivery
Carboxymethylcellulose sodium	Viscosity and suspension control	Helps limit settling and improves redispersion
Dextrose	Tonicity adjustment	Supports nasal tolerability
Polysorbate 80	Wetting and dispersing agent	Helps distribute hydrophobic drug particles
Benzalkonium chloride	Antimicrobial preservative	Enables multidose packaging; possible tolerability concern
Phenethyl alcohol	Preservative and formulation aid	Supports microbial control and sensory profile
Purified water	Vehicle	Main formulation medium

Why the cellulose system matters

Microcrystalline cellulose and carboxymethylcellulose sodium create a structured vehicle that slows sedimentation. This is important because the patient may use the product after storage, transport or an extended interval between doses.

The system must balance competing requirements:

• Sufficient viscosity to limit settling.
• Rapid redispersion after shaking.
• Low resistance during pump actuation.
• Consistent plume geometry.
• Limited post-nasal drip.
• Acceptable throat and taste profile.

Excessive viscosity can reduce spray quality, increase actuation force and create an inconsistent plume. Insufficient viscosity can produce sedimentation and dose nonuniformity.

Why polysorbate 80 matters

Polysorbate 80 improves wetting of fluticasone propionate particles and supports dispersion during manufacturing and use. Its concentration must remain low enough to avoid excessive foaming, altered droplet-size distribution or undesirable sensory effects.

A formulation change involving polysorbate 80 is not automatically commercially valuable. The change must demonstrate a measurable improvement in particle wetting, delivered-dose uniformity, storage stability or spray performance.

Why preservatives create an opportunity

Benzalkonium chloride and phenethyl alcohol support microbial control in a multidose aqueous product. Preservatives also create a possible differentiation path because some patients and clinicians prefer preservative-free intranasal products, particularly for long-term or frequent use.

A preservative-free version would require more than removal of benzalkonium chloride. The product would need an alternative microbial-control strategy, such as:

• A unit-dose container.
• A sterile single-use presentation.
• A validated preservative-free multidose pump.
• A container-closure system that limits microbial ingress.
• A manufacturing and microbiological-control strategy suitable for the proposed device.

A preservative-free multidose product would likely have higher packaging cost and more complex validation requirements. Its commercial value would depend on whether the target channel can support a premium over standard private-label nasal spray.

What excipient strategy is commercially strongest?

The highest-value strategy is a platform approach that combines formulation and device development. A simple excipient substitution is unlikely to create durable market protection unless it produces a clear performance benefit and supports a patentable claim set.

Strategy 1: Preservative-free multidose suspension

This is the strongest patient-facing differentiation opportunity. The target claims could focus on:

• Reduced preservative exposure.
• Stable multidose delivery.
• Controlled microbial ingress.
• Consistent dose delivery over the in-use period.
• Improved local tolerability.

The technical risk is high. Fluticasone propionate is a suspension, and a preservative-free multidose presentation must control both microbial risk and physical stability. A device-led solution may be more defensible than an excipient-only solution.

Strategy 2: Low-drip and low-throat-deposition formulation

Many nasal-spray complaints concern runoff, throat sensation, taste and post-nasal drip. An optimized formulation can target:

• Lower viscosity after actuation.
• Improved droplet-size distribution.
• Lower large-droplet fraction.
• Better plume geometry.
• Reduced runoff from the nasal cavity.

These benefits often arise from the interaction between formulation rheology and pump design. The commercial opportunity is strongest where performance can be demonstrated through validated spray-pattern, plume-geometry, droplet-size and deposition testing.

Strategy 3: Faster redispersion

A suspension that redistributes quickly after shaking can reduce dose variability and improve usability. Potential development variables include:

• Cellulose ratio.
• Particle-size distribution.
• Surface treatment or wetting conditions.
• Polysorbate 80 concentration.
• Mixing and homogenization parameters.
• Container geometry.

A patent position would be stronger if it covered a defined combination of particle size, excipient concentration, viscosity, delivered-dose uniformity and storage stability rather than a broad claim to fluticasone propionate with standard excipients.

Strategy 4: Pediatric and accessibility design

Basic Care products compete on price, but ease of use can create a differentiated subsegment. Opportunities include:

• Lower actuation force.
• Dose counter visibility.
• Grip designed for reduced dexterity.
• Instructions that reduce incorrect priming.
• Child-oriented administration guidance.
• A cap that protects the actuator without increasing contamination risk.

These improvements are more likely to produce device or user-interface patents than formulation patents.

Strategy 5: Extended in-use stability

A product with validated stability after opening could support convenience claims and improve retail inventory management. Relevant variables include:

• Preservative effectiveness.
• Pump backflow.
• Container-closure integrity.
• Microbial ingress.
• Suspension settling.
• Delivered-dose uniformity at the end of labeled use.
• Storage under heat and humidity stress.

The commercial value is meaningful only if the in-use period supports a clear label or packaging advantage.

What patents protect Basic Care Allergy Relief Nasal?

The core fluticasone propionate molecule, basic nasal-spray use and conventional excipient systems do not present a strong current exclusivity barrier. Fluticasone propionate was developed decades ago, and the principal commercial opportunity is generic and private-label substitution.

Patent and exclusivity assessment

Protection category	Current commercial significance
Fluticasone propionate active ingredient	Core composition patents are expired or commercially exhausted
Intranasal allergy indication	Broad use protection is generally expired
Conventional aqueous suspension	Limited protection unless tied to narrow technical parameters
Standard cellulose suspension system	Low standalone patent value
Standard preservative system	Low standalone patent value
Pump and actuator	Potentially relevant if supplier-specific or technically differentiated
Preservative-free multidose system	Potentially patentable
Spray plume and deposition control	Potentially patentable when linked to measurable parameters
Manufacturing process	Potentially protectable as trade secret or process patent
Packaging and container closure	Potentially protectable, especially for preservative-free use

The relevant freedom-to-operate exercise should examine current patents from the product manufacturer, nasal-pump suppliers, branded fluticasone developers and companies commercializing preservative-free intranasal suspensions. Patent risk is more likely to arise from the delivery system or a later-generation formulation than from fluticasone propionate itself.

When does Basic Care Allergy Relief Nasal lose exclusivity?

Basic Care Allergy Relief Nasal is an OTC product and does not have a conventional new-drug patent exclusivity timeline comparable to a newly approved prescription medicine. The commercial product is subject primarily to the OTC monograph framework, labeling requirements, manufacturing controls and any remaining third-party patents.

FDA regulatory status

Fluticasone propionate nasal spray is an established OTC active ingredient for allergic rhinitis. FDA’s OTC monograph system identifies conditions under which certain nonprescription products can be marketed without an individual product approval, subject to applicable requirements.[2]

The product’s relevant regulatory controls include:

• Active ingredient identity and concentration.
• Permitted indication and labeling.
• Delivered-dose performance.
• Microbial quality.
• Container-closure suitability.
• Stability.
• Manufacturing under current good manufacturing practice.
• Drug Facts labeling.
• Device performance for the nasal pump.

The OTC monograph does not eliminate patent risk. It removes the need for an individual new-drug approval when the product conforms to the applicable monograph framework, but a product can still infringe a valid formulation, device, process or packaging patent.

What is the Orange Book status of Basic Care Allergy Relief Nasal?

Basic Care Allergy Relief Nasal is generally not evaluated through the same Orange Book listing and Paragraph IV framework used for abbreviated new drug applications. An OTC monograph product typically does not depend on an ANDA against a listed prescription reference product.

Paragraph IV challenge exposure

A conventional Paragraph IV strategy is unlikely to be the principal pathway for this product because the product is marketed as an OTC monograph drug rather than as a standard ANDA-based generic. The main litigation risks are instead:

• Patent infringement claims involving a nasal pump.
• Formulation patent claims.
• Trade dress or trademark disputes.
• Manufacturing process claims.
• Supplier indemnity disputes.
• Claims involving a branded reference product’s device or packaging.

For a company launching a competing product, an FTO review should cover U.S. patents and applications assigned to branded manufacturers, device suppliers and formulation developers. The review should distinguish expired patents, abandoned applications, live patents and claims that read on the actual commercial configuration.

Which companies compete with Basic Care Allergy Relief Nasal?

The product competes in a crowded OTC nasal-allergy category.

Competitor group	Representative products or companies	Competitive basis
Branded fluticasone	Flonase Allergy Relief, Haleon	Brand recognition and pharmacy presence
Retail private label	Amazon Basic Care and other store brands	Lower price and retailer control
Other corticosteroids	Nasacort, Rhinocort	Alternative active ingredients
Antihistamine sprays	Astepro and generic azelastine	Faster perceived symptom relief
Decongestant sprays	Oxymetazoline products	Short-term congestion relief
Oral allergy medicines	Cetirizine, loratadine, fexofenadine	Convenience and established consumer use

Private-label products can compete effectively when the formulation, pump and packaging are equivalent or sufficiently similar to the branded reference. The principal disadvantage is lower consumer differentiation. This makes device performance, scent and taste, package usability and price important commercial levers.

What generic entry risks exist for Basic Care Allergy Relief Nasal?

Generic and private-label entry risk is structurally high. Fluticasone propionate is an established active ingredient, the OTC category is mature, and multiple manufacturers can source comparable pumps and excipients.

Main entry risks

1. Price erosion. Retailers can switch suppliers or introduce competing store brands.
2. Manufacturing concentration. A limited number of approved nasal-spray manufacturers may control capacity and component sourcing.
3. Pump availability. The actuator and pump can become the supply bottleneck.
4. Quality variation. Small changes in particle size, viscosity or pump components can affect dose delivery.
5. Retailer bargaining power. Private-label contracts may be rebid on price.
6. Low switching costs. Consumers can move between branded and store-brand products.
7. Regulatory variation. Changes to OTC monograph requirements can require labeling or manufacturing updates.

A defensible commercial position therefore requires cost control, reliable supply, and a product attribute that consumers or retailers can identify.

How strong is the patent estate for Basic Care Allergy Relief Nasal?

The patent estate is weak for the conventional product and potentially moderate for a differentiated delivery platform.

Asset	Patent strength	Commercial defensibility
Fluticasone propionate itself	Low	Low
Conventional aqueous suspension	Low	Low
Standard cellulose excipients	Low	Low
Standard preserved multidose spray	Low	Low
Preservative-free multidose device	Moderate to high	Moderate to high
Low-drip deposition system	Moderate	Moderate
Specialized actuator	Moderate	Moderate
Manufacturing process	Moderate	High if kept confidential
Retail brand and channel access	Not a patent asset	High if contractually protected

The strongest protection may be trade secret rather than patent protection. Manufacturing controls for particle wetting, order of addition, mixing energy, filling parameters and pump crimping can affect performance. These parameters are difficult to reverse engineer completely and can protect margin even where the final ingredient list is public.

What manufacturing and IP barriers affect commercial expansion?

The principal manufacturing barrier is reproducible delivery of a poorly water-soluble corticosteroid from a multidose suspension.

Critical process parameters

• Fluticasone propionate particle-size distribution.
• Wetting and deagglomeration.
• Order of excipient addition.
• Hydration of cellulose polymers.
• Mixing speed and shear.
• Suspension hold time.
• Fill-volume accuracy.
• Pump attachment and crimp control.
• Priming and repriming behavior.
• Container-closure integrity.
• End-of-life delivered-dose uniformity.

A formulation may pass basic assay testing and still fail commercial expectations if the spray pattern, plume, droplet-size distribution or first-dose performance is inconsistent.

Supplier and licensing opportunities

The most attractive licensing targets are likely to be:

• Preservative-free multidose nasal-pump technology.
• Low-actuation-force pump systems.
• Spray-pattern and deposition technologies.
• Fluticasone propionate suspension manufacturing platforms.
• Contract manufacturing capacity with validated nasal-spray processes.
• Retail private-label rights for a differentiated presentation.

A licensing agreement should address patent ownership, improvements, regulatory filings, component supply, technology transfer, validation batches, quality agreements and freedom-to-operate indemnity. The agreement should also define whether the license covers only fluticasone propionate or extends to other intranasal corticosteroids.

What commercial opportunities exist for excipient innovation?

The best opportunities are product extensions rather than a direct replacement for the standard low-cost spray.

Priority opportunity matrix

Opportunity	Patient value	Technical difficulty	Patent potential	Commercial priority
Preservative-free multidose spray	High	High	High	High
Low-drip formulation and device	Moderate to high	Moderate	Moderate	High
Faster redispersion	Moderate	Moderate	Moderate	Medium
Lower actuation force	Moderate	Moderate	Device-focused	Medium
Improved taste and throat profile	Moderate	Moderate	Low to moderate	Medium
Extended in-use stability	Moderate	High	Moderate	Medium
Unit-dose presentation	High for selected users	High	Moderate	Selective
Cheaper conventional suspension	Low	Low	Low	High for private label

The economic case depends on channel. A standard private-label product should prioritize cost, supply continuity and equivalent performance. A differentiated product can support a higher price if it offers a visible benefit, such as preservative-free delivery or reduced runoff.

Key Takeaways

• Basic Care Allergy Relief Nasal is an OTC fluticasone propionate nasal-spray product positioned against Flonase Allergy Relief and other private-label alternatives.
• The conventional excipient system uses cellulose polymers, a wetting agent, tonicity agents, preservatives and purified water.
• The product is a suspension, making particle size, redispersion, viscosity and pump performance central to quality.
• Core fluticasone propionate and conventional nasal-spray protection provide limited current exclusivity.
• Orange Book and Paragraph IV mechanisms are generally less central than they are for prescription ANDA products.
• The strongest commercial opportunities are preservative-free multidose delivery, low-drip performance, improved usability and validated in-use stability.
• Manufacturing know-how may provide greater practical protection than a broad excipient patent.
• Retail private-label competition creates high price and supplier-switching risk.

FAQs

Can a new fluticasone propionate nasal spray use the same excipients?

A competing product can use the same excipients if it meets applicable OTC, quality, labeling and patent requirements. Similarity of the ingredient list does not establish identical performance, particularly for a suspension and pump combination.

Is benzalkonium chloride necessary in a multidose nasal spray?

It is not universally necessary, but removing it requires a validated alternative microbial-control strategy. The replacement may involve a preservative-free pump, unit-dose packaging or another container-closure approach.

Can excipient changes support a patent for fluticasone nasal spray?

Yes, but patent value depends on technical specificity and demonstrated benefit. Claims are stronger when they connect defined excipient ranges with measurable improvements in stability, dose uniformity, spray performance or tolerability.

Is a preservative-free Basic Care nasal spray likely to command a premium?

It can command a premium in selected channels if the benefit is clearly communicated and supported by performance data. The premium must offset higher device, validation and manufacturing costs.

What is the most important quality test for this product?

Delivered-dose uniformity over the product’s labeled life is one of the most important tests. It should be assessed alongside assay, spray content uniformity, particle-size distribution, spray pattern, plume geometry, microbial quality and stability.

References

1. National Library of Medicine. (n.d.). DailyMed: Fluticasone propionate nasal spray labeling. U.S. National Library of Medicine.
2. U.S. Food and Drug Administration. (2022). Nasal decongestant, anticholinergic, and antihistamine products for over-the-counter human use; final monograph and related requirements. 21 C.F.R. Part 341.
3. U.S. Food and Drug Administration. (2024). Nonprescription drug products and over-the-counter monograph framework. FDA.
4. U.S. Food and Drug Administration. (1999). Nasal spray and inhalation solution, suspension, and spray drug products: Chemistry, manufacturing, and controls documentation. FDA.
5. United States Pharmacopeia. (2024). General chapter <601>: Inhalation and nasal drug products. USP-NF.