Sodium monofluorophosphate

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

12 more strengths and forms are listed in the FDA NDC Directory.

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

• Colgate-Palmolive Company27 products
• Tom's of Maine, Inc.14 products
• White Glo USA Inc9 products
• The Procter & Gamble Manufacturing Company9 products
• Robell Research, Inc8 products
• Lamoiyan Corporation7 products
• Guangzhou City Caiye Cosmetics CO., Ltd5 products
• Universal Distribution Center LLC4 products
• Pigeon Corporation4 products
• The Kind Lab, Inc.2 products
• Maxill Inc.2 products
• Whole Foods Market, Inc.2 products
• New World Imports, Inc2 products
• Target2 products
• Bob Barker Company Inc.2 products
• Health and Natural Beauty USA Corp2 products
• Ming Fai Industrial (Shenzhen) Co. Ltd2 products
• Ashtel Studios, Inc.2 products
• Dong Il Pharms Co., Ltd2 products
• American Airlines, Inc.2 products
• Dynarex Corporation2 products
• Procter & Gamble Manufactura, S de R.L. de C.V.2 products
• Rorobell1 product
• Hunan Yinhuatang Pharmaceutical Technology Co., Ltd.1 product
• Colgate-Palmolive (Thailand) Limited - Branch1 product
• Foodhold U.S.A.1 product
• The Kroger Co.1 product
• Ranir LLC1 product
• Orazen Inc1 product
• Mkj Brands LLC1 product

Showing the 30 companies with the most products, of 54.

Recalls

From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.

1. September 17, 2018 · Class II · Terminated · D-0247-2019

   Microbial Contamination of Non-Sterile Product

   SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product — Medline Industries Inc

Sources

1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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