Antigingivitis/Antiplaque

Antigingivitis/Antiplaque is an FDA-registered drug product whose active ingredient is CETYLPYRIDINIUM CHLORIDE. It is labelled by Nice-Pak Products, LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 11344-900, application 505G(a)(3), label effective 20260821. 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 control, leads gingivitis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use helps control plaque that leads to gingivitis

Directions adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day do not swallow children 6 years to under 12 years of age: supervise use when used after brushing, rinse mouth with water first children under 6 years of age: do not use

Warnings For this product

Adverse reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593

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.

3 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 Antigingivitis/Antiplaque used for?
Use helps control plaque that leads to gingivitis

Who makes Antigingivitis/Antiplaque?
Nice-Pak Products, LLC is the labeler of record for Antigingivitis/Antiplaque. 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 Antigingivitis/Antiplaque 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 Antigingivitis/Antiplaque 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 Antigingivitis/Antiplaque been recalled?
3 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.