Registered Malawi · PMRA

CEPACOL 0.5MG/ML MOUTHWASH

CETYLPYRIDINIUM CHLORIDE

PMPB/PL1/12 MOUTHWASH blood and blood forming organs INN generic

What it does

Cetylpyridinium is a compound often used in oral care products for its antibacterial properties.

Commonly used for: mouth infections, sore throat, bad breath (halitosis)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL1/12
Registration date
06/03/2001
Expiry date
31/03/2024
Status
Registered
Active ingredient
CETYLPYRIDINIUM CHLORIDE
Dosage form
MOUTHWASH
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
B05CA - Antiinfectives
RxNorm RxCUI
2286
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:38 · updated 2026-09-19 04:30:21

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cetylpyridinium is a compound often used in oral care products for its antibacterial properties.

What it treats

  • mouth infections
  • sore throat
  • bad breath (halitosis)

How it works

It helps to kill germs in the mouth and throat, reducing infection and discomfort.

Who it's for

Suitable for adults and children who need relief from oral discomfort and infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: cetylpyridinium

BNF-referenced

Cetylpyridinium is a quaternary ammonium compound with broad-spectrum antibacterial properties, primarily used in oral care products such as mouthwashes, toothpastes, and lozenges. It serves to reduce dental plaque formation, inhibit pathogenic bacterial growth, and diminish the virulence of these microorganisms. The compound is known for its surfactant properties, which enhance its ability to adhere to oral surfaces and exert a prolonged antimicrobial effect.

Indications

  • Oral hygiene
  • Prevention of dental plaque
  • Management of minor infections in the oral cavity

Dosage

Children: Refer to BNF for Children for appropriate formulations and guidance on paediatric use.

Adults: Refer to BNF for specific formulations and usage instructions. Typical concentrations in mouthwashes are around 0.05% to 0.1%.

Mechanism of action

Cetylpyridinium chloride functions as a cationic surfactant that interacts with microbial cell surfaces due to its positively charged hydrophilic region. This interaction disrupts bacterial membrane integrity, leading to leakage of cytoplasmic components, interference with cellular metabolism, and ultimately, cell death. Additionally, it inhibits the synthesis of insoluble glucan by streptococcal glucosyltransferase, adsorbs to enamel surfaces, and prevents bacterial co-adhesion, enhancing its effectiveness in oral hygiene.

Pharmacodynamics

Cetylpyridinium chloride exhibits rapid bactericidal effects against gram-positive pathogens and fungicidal activity against yeasts. It is classified as a cationic disinfectant with local effects, making it suitable for managing minor infections. Its surfactant properties contribute to its efficacy in reducing microbial load in oral care applications.

Pharmacokinetics

Cetylpyridinium chloride is characterized by poor systemic absorption when used topically; therefore, its effects are primarily local rather than systemic. This property allows it to exert its antimicrobial action in the mouth without significant absorption into the bloodstream, making it safe for use in oral care products.

Adverse effects

  • Mouth irritation
  • Taste alteration
  • Dryness of the mouth
  • Nausea
  • Diarrhea

Precautions

  • Use with caution in individuals with a history of hypersensitivity to cetylpyridinium chloride or other quaternary ammonium compounds.
  • Avoid swallowing the product.
  • Not recommended for use in children under a certain age without medical advice.

Pregnancy

Cetylpyridinium chloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consultation with a healthcare provider is advised.

Breast-feeding

It is not known whether cetylpyridinium chloride is excreted in human milk. Caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from direct sunlight and moisture. Keep out of reach of children.

Formulations

  • Mouthwash
  • Toothpaste
  • Lozenges
  • Mouth sprays

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: cetylpyridinium

PubChem CID 2683

Molecular formula: C21H38N+

Mechanism of action

When incorporated into mouthwashes, toothpastes, lozenges, or mouth sprays, cetylpyridinium chloride is expected to elicit a mechanism of action that decreases new dental plaque growth, decreases or removes existing dental plaque, diminishes the growth of pathogenic bacteria, and inhibits the production of virulence factors. Cetylpyridinium chloride is a quaternary ammonium compound that demonstrates a broad spectrum anti-bacterial activity. It possesses a cationic surface active agent surfactant which can absorb readily to oral surfaces. The molecules of this agent have both hydrophilic and hydrophobic groups. In action, the positively charged hydrophilic region of cetylpyridinium chloride molecules enables the compound to interact with microbial cell surfaces and even integrate into the bacterial cytoplasmic membrane. Consequently, there is a resultant disruption of bacterial membrane integrity causing a leakage of bacterial cytoplasmic components, interference with cellular metabolism, inhibition of cell growth, and ultimately - cell death. Moreover, cetylpyridinium chloride can also inhibit the synthesis of insoluble glucan by streptococcal glucosyltransferase, adsorb to pellicle-covered enamel, and inhibit co-adhesion of bacteria, and bind streptococcus mutans biofilms. This ability of cetylpyridinium chloride to be able to adsorb to pellicle covered enamel imparts substantivity to the compound molecules - that is retention in the mouth and continued antimicrobial activity for a period of time after rinsing. Taking these mechanisms into consideration, cetylpyridinium chloride may be considered an active ingredient that is effective in the treatment and prevention of bacterial or fungal disorders of the oropharyngeal cavity.

Pharmacodynamics

Cetylpyridinium chloride is considered a cationic disinfectant with properties and uses similar to other such cationic surfactants. In particular, cetylpyridinium chloride has demonstrated a rapid bactericidal and fungicide effect on gram-positive pathogens and yeasts, respectively. Cetylpyridinium chloride is subsequently utilized in a variety of preparations for the local treatment of minor infections. Despite the variety of formulations in which cetylpyridinium chloride may appear as an active ingredient, it is generally accepted that it only elicits a local effect owing to the compound's relatively poor absorption by route of exposure.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.