Natural Fluoride Fresh Mint cavity protection whitening fresh breath

SODIUM FLUORIDE DENTAL HUMAN OTC DRUG

Natural Fluoride Fresh Mint cavity protection whitening fresh breath is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Tom's of Maine, Inc. administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260616.

Generic name
SODIUM FLUORIDE
Manufacturer
Tom's of Maine, Inc.
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
51009-238
Application
M021
Label effective
20260616

About this product

Natural Fluoride Fresh Mint cavity protection whitening fresh breath 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 51009-238, application M021, label effective 20260616. 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.

What it is used for

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.

Active ingredients

Active ingredient Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Indications & Usage

Use helps protect against cavities

Dosage & Administration

Directions adults and children 2 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 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 physician

Warnings

Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

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How products containing SODIUM FLUORIDE compare

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.

Dosage formProductsManufacturerProducts
— — Colgate-Palmolive Company 34
— — The Procter & Gamble Manufacturing Company 25
— — Church & Dwight Co., Inc. 14
— — Burkhart Dental Supply Inc 12
— — Dharma Research, inc. 12

Frequently asked questions

What is Natural Fluoride Fresh Mint cavity protection whitening fresh breath used for?
Use helps protect against cavities

Who makes Natural Fluoride Fresh Mint cavity protection whitening fresh breath?
Tom's of Maine, Inc. is the labeler of record for Natural Fluoride Fresh Mint cavity protection whitening fresh breath. 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 Natural Fluoride Fresh Mint cavity protection whitening fresh breath 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 Natural Fluoride Fresh Mint cavity protection whitening fresh breath 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 Natural Fluoride Fresh Mint cavity protection whitening fresh breath 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.