Sodium Fluoride

Sodium Fluoride is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Safco Dental Supply LLC taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 67239-0227, application M021, label effective 20231011. 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: helps protect, against cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use: Helps protect against cavities

Directions: Adults and Children 6-years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Children 2 to 6 years Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years Ask a dentist or a physician

Warning: KEEP OUT OF THE REACH OF CHILDREN UNDER 6 YEARS OF AGE. If you accidentally swallow more than used for brushing, seek professional assistance or contact a Poison Control Center immediately.

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.

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 Sodium Fluoride used for?
Use: Helps protect against cavities

Who makes Sodium Fluoride?
Safco Dental Supply LLC is the labeler of record for Sodium Fluoride. 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 Sodium Fluoride 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 Sodium Fluoride 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 Sodium Fluoride 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.