Listerine Total Care Fresh Mint Anticavity
Listerine Total Care Fresh Mint Anticavity is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Kenvue Brands LLC administered by ORAL. 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 20260828.
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Kenvue Brands LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 69968-0178
- Application
- M021
- Label effective
- 20260828
About this product
Listerine Total Care Fresh Mint Anticavity is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Kenvue Brands LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 69968-0178, application M021, label effective 20260828. 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: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Use aids in the prevention of dental cavities
Dosage & Administration
Directions Adults and children 6 years of age and older: use twice daily after brushing your teeth with a toothpaste vigorously swish 10mL (2 teaspoonfuls) 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 supervise children as necessary until capable of using without supervision Children under 6 years of age: consult a dentist or doctor
Warnings
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 .
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View labelHow 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 form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Colgate-Palmolive Company | 34 |
| — | — | The Procter & Gamble Manufacturing Company | 25 |
| — | — | Church & Dwight Co., Inc. | 14 |
| — | — | Burkhart Dental Supply Inc | 12 |
| — | — | Dharma Research, inc. | 12 |
Recall and safety notices
1 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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0121-2026 | TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04. | Kenvue Brands LLC | Class II | Ongoing | 20251105 |
Frequently asked questions
What is Listerine Total Care Fresh Mint Anticavity used for?
Use aids in the prevention of dental cavities
Who makes Listerine Total Care Fresh Mint Anticavity?
Kenvue Brands LLC is the labeler of record for Listerine Total Care Fresh Mint Anticavity. 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 Listerine Total Care Fresh Mint Anticavity 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 Listerine Total Care Fresh Mint Anticavity 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 Listerine Total Care Fresh Mint Anticavity been recalled?
1 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.
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.