List of Excipients in Branded Drug PERIOGARD ALCOHOL FREE

Generic Drugs Containing PERIOGARD ALCOHOL FREE

Company	Ingredient	NDC	Excipient
Colgate Oral Pharmaceuticals Inc	chlorhexidine gluconate	0126-0272	CETYLPYRIDINIUM CHLORIDE
Colgate Oral Pharmaceuticals Inc	chlorhexidine gluconate	0126-0272	FD&C BLUE NO. 1
Colgate Oral Pharmaceuticals Inc	chlorhexidine gluconate	0126-0272	GLYCERIN
Colgate Oral Pharmaceuticals Inc	chlorhexidine gluconate	0126-0272	PEG-40 CASTOR OIL

What are the Most Frequently-Used Excipients in PERIOGARD ALCOHOL FREE?

# Of NDCs	Excipient
3	CETYLPYRIDINIUM CHLORIDE
3	FD&C BLUE NO. 1
3	GLYCERIN
3	PEG-40 CASTOR OIL

PerioGard Alcohol Free Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 24, 2026

PerioGard Alcohol Free is a prescription oral rinse containing 0.12% chlorhexidine gluconate. Its commercial differentiation comes from the alcohol-free vehicle, tolerability positioning, brand recognition, and dental-channel distribution rather than from a durable patent or regulatory exclusivity position. The formulation uses a relatively simple excipient system: purified water, glycerin, poloxamer 407, sodium saccharin, flavor, and FD&C Blue No. 1. The principal opportunities are reformulation, private-label supply, indication-adjacent products, and improved delivery systems.

What is PerioGard Alcohol Free and what excipients does it contain?

PerioGard Alcohol Free is an oral rinse indicated for reducing gingivitis, including reduction of gingival inflammation, redness, and bleeding in patients who use the product as part of a professional dental program.[1]

Attribute	PerioGard Alcohol Free
Active ingredient	Chlorhexidine gluconate 0.12%
Dosage form	Oral rinse
Administration	Rinse with 15 mL for 30 seconds, generally twice daily
Alcohol content	Alcohol-free formulation
Regulatory category	Prescription dental product
Original sponsor	Colgate-Palmolive Company
Reference product	PerioGard chlorhexidine gluconate oral rinse
Primary use	Gingivitis management
Route	Oral topical
Principal vehicle	Aqueous
Known formulation role	Solubilization, taste management, mouthfeel, color, and product stability

The FDA-approved labeling identifies the inactive ingredients as FD&C Blue No. 1, flavor, glycerin, poloxamer 407, sodium saccharin, and water.[1] The formulation does not depend on ethanol for antimicrobial performance. Chlorhexidine gluconate is the pharmacologically active antimicrobial agent.

What roles do the PerioGard Alcohol Free excipients perform?

Excipient	Likely formulation function
Purified water	Continuous phase and solvent
Glycerin	Humectant, mouthfeel modifier, and viscosity contributor
Poloxamer 407	Surfactant, wetting aid, solubilization support, and mouthfeel modifier
Sodium saccharin	High-intensity sweetener
Flavor	Taste masking and consumer acceptability
FD&C Blue No. 1	Product identification and visual differentiation

The excipient strategy is conservative. It avoids ethanol-related burning or dryness concerns while retaining a clear, recognizable mouth-rinse format. Glycerin and poloxamer 407 help compensate for the sensory and physical differences created by removing alcohol.

How does the alcohol-free formulation create commercial value?

The alcohol-free platform supports several commercial claims and market segments:

1. Patients who experience burning or dryness from alcohol-containing rinses.
2. Dental practices seeking prescription chlorhexidine products with a more tolerable sensory profile.
3. Consumers and caregivers who prefer alcohol-free oral-care products.
4. Institutional purchasers that require alcohol-free products for specific patient populations.
5. Private-label and contract-manufacturing customers seeking a familiar chlorhexidine formulation.

The commercial value is primarily behavioral. A more acceptable rinse can improve use during the prescribed treatment period. The product still has clinically relevant limitations, including tooth staining, increased calculus formation, altered taste, and the need for supervised use.[1]

Alcohol-free positioning does not, by itself, establish a new FDA exclusivity right. It can support branding, trade dress, product specifications, and customer preference, but those protections are narrower than active-ingredient or formulation patents.

What patents protect PerioGard Alcohol Free?

The principal active ingredient, chlorhexidine gluconate, is an established compound. The product’s original regulatory and commercial protection has expired. No current patent-based exclusivity should be assumed for the listed PerioGard Alcohol Free formulation.

The FDA Orange Book is the relevant source for patents and regulatory exclusivity associated with approved prescription products.[2] A product-specific patent assessment should distinguish among:

• Active-ingredient patents, which are no longer commercially relevant for chlorhexidine gluconate.
• Formulation patents, which could cover excipient ratios, pH, preservative systems, flavor systems, or stability performance.
• Method-of-use patents, which could cover specific dental or periodontal uses.
• Manufacturing patents, which could cover mixing, filtration, filling, packaging, or impurity control.
• Trademark and trade-dress rights, which are separate from pharmaceutical patent rights.

For PerioGard Alcohol Free, the commercial barrier is not a clearly identifiable live patent estate. The formulation is composed of widely used excipients with established regulatory precedent. A competitor can generally pursue an abbreviated or alternative regulatory pathway if it satisfies FDA requirements for quality, safety, efficacy, labeling, and product sameness or therapeutic equivalence.

Does PerioGard Alcohol Free have Orange Book exclusivity?

No meaningful current Orange Book exclusivity should be expected for this mature chlorhexidine product. Any original approval exclusivity would have expired long ago, and the active ingredient is not protected by a current new chemical entity period.

The relevant FDA pathway for a competing prescription product depends on the reference listing and the product’s formulation. A generic applicant may pursue an abbreviated new drug application if the reference product and proposed product meet applicable requirements. FDA’s Orange Book and product-specific guidance determine the precise pathway.[2,3]

When does PerioGard Alcohol Free lose exclusivity?

PerioGard Alcohol Free has already passed the period of active-ingredient, original approval, and conventional market exclusivity. The product should be treated as a mature branded prescription oral rinse.

Protection category	Commercial status
New chemical entity exclusivity	Expired or not applicable
Original formulation exclusivity	Expired
Active-ingredient patent	Expired
Current formulation patent protection	No verified durable protection identified
Method-of-use protection	No verified current protection identified
Trademark protection	Potentially ongoing, subject to registration and use
Trade dress	Potentially ongoing, subject to enforceability
Regulatory barriers	Product-specific FDA requirements remain

A generic manufacturer therefore faces regulatory and commercial execution risk rather than a fundamental patent block.

What generic entry risks exist for PerioGard Alcohol Free?

Generic entry risk is high because chlorhexidine gluconate oral rinses are established products with simple aqueous dosage forms. The main competitive risks include:

• ANDA approval for a therapeutically equivalent chlorhexidine oral rinse.
• Private-label products supplied to dental distributors.
• Hospital and clinic tenders favoring lower-cost products.
• Online pharmacy substitution.
• Contract-manufactured alcohol-free chlorhexidine products.
• Imported or non-U.S. products where legally permitted.

A generic launch may still encounter technical barriers. Chlorhexidine is cationic and can interact with anionic excipients, packaging components, flavor systems, and other oral-care ingredients. The applicant must control assay, pH, preservative performance, microbial quality, viscosity, appearance, taste, and container compatibility.

Are Paragraph IV challenges relevant?

A Paragraph IV challenge is relevant only when an Orange Book-listed patent remains applicable. Because PerioGard Alcohol Free is a mature product and no current blocking patent has been established here, a Paragraph IV strategy is unlikely to be the main entry route.

The more probable route is an ANDA or another FDA-approved pathway based on the applicable reference product. A formal Paragraph IV assessment requires current Orange Book patent listings and FDA litigation records.[2,4]

What formulation patents could protect an improved chlorhexidine rinse?

A new formulation would need more than a routine substitution of one excipient. Patentable differentiation could arise from a demonstrable technical effect, such as improved stability, reduced staining, better taste, reduced mucosal irritation, or enhanced retention.

Potential claim areas include:

Low-staining chlorhexidine formulations

Chlorhexidine-associated staining is a major limitation. A formulation that reduces staining without materially reducing antimicrobial activity could support a composition or method-of-use patent. Potential approaches include controlled complexation, optimized flavor systems, stain-inhibiting excipients, or modified dosing formats.

The technical challenge is avoiding interference with chlorhexidine’s cationic antimicrobial action.

Taste-masked formulations

Flavor and sweetener systems could be optimized to reduce bitterness and persistent taste alteration. A patent would be stronger if it tied a defined flavor composition or excipient ratio to measured sensory improvement and retained antimicrobial performance.

Mucoadhesive or sustained-contact systems

A gel, film, bioadhesive rinse, or low-volume concentrate could increase contact time and reduce dosing frequency. Such systems may support differentiated claims, but they would require new clinical and stability data.

Preservative-free or low-preservative systems

An optimized packaging system, sterile process, or antimicrobial-compatible container could reduce reliance on traditional preservatives. The product would need validated microbial control and stability data.

Pediatric or special-population systems

A lower-volume, unit-dose, non-swallowable, or caregiver-administered format could address institutional or special-needs markets. Chlorhexidine use in children requires careful labeling and safety review.

How should an excipient strategy be designed for a next-generation product?

A commercially credible strategy should begin with the known limitations of the current formulation.

Development objective	Candidate strategy	Key risk
Reduce oral burning	Maintain alcohol-free vehicle; optimize flavor and pH	Reduced antimicrobial performance or poor taste
Improve mouthfeel	Adjust glycerin and poloxamer 407 levels	Excess viscosity or residue
Reduce staining	Screen compatible stain-control excipients	Chlorhexidine binding and activity loss
Improve taste	Flavor encapsulation or optimized sweetener system	Regulatory and sensory complexity
Extend shelf life	Optimize pH, oxygen exposure, and packaging	Color or assay drift
Increase compliance	Unit-dose or lower-volume delivery	Higher packaging cost
Support institutional use	Single-use cups or tamper-evident packaging	Manufacturing and sustainability cost
Differentiate from generics	Proprietary excipient ratio or delivery format	Patentability and clinical proof

Poloxamer 407 is particularly relevant because it can influence wetting, solubilization, viscosity, and sensory performance. Its level must be controlled because excessive polymer can create an undesirable mouth coating or affect dispensing. Glycerin can improve mouthfeel but may increase sweetness, viscosity, and packaging interactions.

The pH should remain compatible with chlorhexidine stability, oral tolerability, flavor performance, and container materials. Excipient selection should also avoid anionic materials that may bind or inactivate cationic chlorhexidine.

What FDA regulatory status applies to reformulated products?

A materially reformulated prescription chlorhexidine rinse may require more than a simple manufacturing change. The regulatory pathway depends on the extent of the change and the intended claims.

Potential routes include:

• ANDA for a therapeutically equivalent generic product.
• Supplemental approval for changes to an existing approved product.
• New drug application for a materially different formulation, delivery system, or claim set.
• 505(b)(2) application for a reformulated or repurposed product relying partly on existing findings.

A new indication, altered dosing regimen, sustained-release format, pediatric use, or materially different delivery system may require clinical bridging or new clinical evidence. FDA postapproval change requirements and pharmaceutical quality rules apply to formulation, manufacturing, packaging, and labeling changes.[3,5]

Which companies are challenging or competing with PerioGard Alcohol Free?

Competition comes from several groups rather than a single direct rival:

• Generic chlorhexidine gluconate oral-rinse manufacturers.
• Dental suppliers with private-label products.
• Other prescription chlorhexidine brands.
• Alcohol-containing chlorhexidine rinses.
• Over-the-counter antiseptic and antigingivitis rinses.
• Professional-use periodontal products with alternative actives.

The strongest commercial threat is a lower-priced alcohol-free generic with equivalent concentration, acceptable taste, and reliable dental-distribution access. Over-the-counter products compete for routine oral-care spending but generally do not replicate the prescription positioning of 0.12% chlorhexidine gluconate.

What licensing and manufacturing opportunities exist?

The most attractive opportunities are licensing and supply transactions based on formulation know-how rather than patent rights.

Potential deal structures include:

1. Contract manufacturing of an alcohol-free chlorhexidine rinse for dental distributors.
2. Private-label products for dental service organizations.
3. Regional licensing of a differentiated low-staining formulation.
4. Co-development of unit-dose products for hospitals and nursing facilities.
5. Supply agreements for preservative-optimized or taste-masked formulations.
6. Acquisition or licensing of packaging technology that improves dose control and reduces contamination.

Manufacturing barriers are manageable but important. The producer needs validated mixing order, control of chlorhexidine concentration, microbial limits, fill-volume accuracy, container compatibility, and flavor uniformity. Manufacturing scale can reduce cost, but the product’s relatively low complexity limits the premium available for ordinary formulation know-how.

How strong is the PerioGard Alcohol Free patent estate?

The patent estate is weak as a barrier to generic entry. The product’s strongest assets are brand recognition, dental professional familiarity, distribution, labeling history, and formulation execution.

Asset	Relative strength
Active ingredient exclusivity	None
Original regulatory exclusivity	None remaining
Basic aqueous formulation	Low patent defensibility
Alcohol-free positioning	Commercially useful, weak as standalone IP
Brand and trademark	Potentially meaningful
Dental-channel relationships	Commercially meaningful
Proprietary low-staining technology	Potentially strong if technically demonstrated
Specialty packaging	Moderate if protected and cost-effective

Key Takeaways

• PerioGard Alcohol Free contains 0.12% chlorhexidine gluconate in an aqueous excipient system.
• Its listed excipients are water, glycerin, poloxamer 407, sodium saccharin, flavor, and FD&C Blue No. 1.
• The product’s value comes from alcohol-free tolerability, brand, and dental distribution, not current patent exclusivity.
• Generic entry risk is high because the active ingredient and basic dosage form are mature.
• The best formulation opportunities involve reduced staining, improved taste, sustained contact, unit-dose packaging, and improved compliance.
• A new patent position would require a measurable technical effect, not a routine excipient substitution.
• Licensing potential is strongest in private-label manufacturing, dental-channel supply, and differentiated reformulations.
• Chlorhexidine’s cationic chemistry creates meaningful compatibility risks with anionic excipients and packaging materials.

FAQs

Is PerioGard Alcohol Free the same as chlorhexidine mouthwash?

PerioGard Alcohol Free is a specific prescription chlorhexidine gluconate oral rinse containing 0.12% active ingredient. Other chlorhexidine mouthwashes may use different excipients, manufacturers, labels, packaging, or regulatory status.

Can an alcohol-free chlorhexidine rinse be sold over the counter?

A manufacturer would need an FDA-compliant regulatory pathway and labeling appropriate for the proposed use. The prescription status of the reference product does not automatically authorize over-the-counter sale.

What is the main excipient risk in a chlorhexidine oral rinse?

The main risk is chemical or functional incompatibility with excipients that bind cationic chlorhexidine or reduce its antimicrobial availability. Flavor, pH, viscosity, preservative performance, and container compatibility also require control.

Can a low-staining chlorhexidine formulation receive patent protection?

Potentially, if the formulation produces a reproducible, non-obvious reduction in staining while preserving antimicrobial activity and meeting stability and safety requirements. Routine flavor or sweetener changes would provide weaker patent prospects.

Is biosimilar risk relevant to PerioGard Alcohol Free?

No. PerioGard Alcohol Free contains a small-molecule antiseptic active ingredient, not a biologic. The relevant competitive risks are generic, private-label, and reformulated oral-rinse products.

References

1. U.S. Food and Drug Administration. (n.d.). PerioGard alcohol-free chlorhexidine gluconate oral rinse 0.12% prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

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

3. U.S. Food and Drug Administration. (2024). Abbreviated new drug application submissions: Content and format. https://www.fda.gov/drugs

4. U.S. Food and Drug Administration. (n.d.). Paragraph IV patent certifications and patent litigation. https://www.fda.gov/drugs

5. U.S. Food and Drug Administration. (2017). Changes to an approved NDA or ANDA: Guidance for industry. https://www.fda.gov/drugs/postapproval-changes-drug-substances-drug-products### Sources: