TheraBreath

TheraBreath is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Church & Dwight Co., Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 10237-274, application M021, label effective 20260909. 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 18 years of age or older: Use once 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.

Warnings Whitening Oral Rinse Keep out of reach of children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If spilled on fabrics, wash out immediately. This product was sealed with protective packaging. If seal is broken or missing, do not use. Anticavity Oral Rinse Keep out of the 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.

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 TheraBreath used for?
Use Aids in the prevention of dental cavities

Who makes TheraBreath?
Church & Dwight Co., Inc. is the labeler of record for TheraBreath. 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 TheraBreath 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 TheraBreath 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 TheraBreath 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.