Toms Whole Care Mouthwash Fresh Mint

Toms Whole Care Mouthwash Fresh Mint is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Tom's of Maine, Inc. taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 51009-837, application M021, label effective 20260610. It is one of 263 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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 SODIUM FLUORIDE are most often described in connection with: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use aids in the prevention of dental cavities

Directions Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor

Warnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

FDA lists 263 drug label records with SODIUM FLUORIDE 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.

What is Toms Whole Care Mouthwash Fresh Mint used for?
Use aids in the prevention of dental cavities

Who makes Toms Whole Care Mouthwash Fresh Mint?
Tom's of Maine, Inc. is the labeler of record for Toms Whole Care Mouthwash Fresh Mint. 263 FDA label records share the active ingredient SODIUM FLUORIDE, 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 Toms Whole Care Mouthwash Fresh Mint come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Toms Whole Care Mouthwash Fresh Mint 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 SODIUM FLUORIDE?
Yes. 263 FDA drug label records list SODIUM FLUORIDE 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 Toms Whole Care Mouthwash Fresh Mint been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.