Cepacol Antibacterial

Cepacol Antibacterial is an FDA-registered drug product whose active ingredient is CETYLPYRIDINIUM CHLORIDE. It is labelled by Reckitt Benckiser LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 63824-790, application 505G(a)(3), label effective 20260513. It is one of 14 FDA drug label records sharing the active ingredient CETYLPYRIDINIUM CHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CETYLPYRIDINIUM CHLORIDE are most often described in connection with: helps prevent, reduce plaque, leads gingivitis, early form, gum disease, bleeding gums. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps prevent and reduce plaque that leads to: gingivitis, an early form of gum disease bleeding gums

Directions adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse children 6 years to under 12 years of age: supervise use children under 6 years of age: do not use.

Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of the reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 14 drug label records with CETYLPYRIDINIUM CHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Cepacol Antibacterial used for?
Uses helps prevent and reduce plaque that leads to: gingivitis, an early form of gum disease bleeding gums

Who makes Cepacol Antibacterial?
Reckitt Benckiser LLC is the labeler of record for Cepacol Antibacterial. 14 FDA label records share the active ingredient CETYLPYRIDINIUM CHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cepacol Antibacterial come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cepacol Antibacterial prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CETYLPYRIDINIUM CHLORIDE?
Yes. 14 FDA drug label records list CETYLPYRIDINIUM CHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cepacol Antibacterial been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.