Mouthwash

Mouthwash is an FDA-registered drug product whose active ingredient is EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL. It is labelled by DISCOUNT DRUG MART taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 53943-514, application 505G(a)(3), label effective 20260505. It is one of 23 FDA drug label records sharing the active ingredient EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL. 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 EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL are most often described in connection with: help reduce, prevent plaque. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses to help reduce and prevent plaque and gingivitis.

Directions rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night. Do not swallow.

Warnings Do not use for children under 12 years of age. Keep out of reach of children If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

FDA lists 23 drug label records with EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL 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 Mouthwash used for?
Uses to help reduce and prevent plaque and gingivitis.

Who makes Mouthwash?
DISCOUNT DRUG MART is the labeler of record for Mouthwash. 23 FDA label records share the active ingredient EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL, 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 Mouthwash 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 Mouthwash 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 EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL?
Yes. 23 FDA drug label records list EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL 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 Mouthwash 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.