FDA Registration for Anticaries Drug Products

Fluoride-containing products such as toothpaste with fluoride are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for Anticaries Drug Products

Anticaries drug products (fluoride toothpastes and fluoride rinses) are regulated as OTC drugs by FDA. Active ingredients include sodium fluoride, sodium monofluorophosphate, and stannous fluoride.

Manufacturers of fluoride toothpaste and other anticaries products must register with FDA as drug establishments, obtain an NDC labeler code, and list each product with Drug Facts labeling.

FDA Drug Establishment Registration
NDC Labeler Code
Drug Listing with Drug Facts labeling
Annual renewal October 1–December 31

The FDA established an OTC monograph specifically for over-the-counter (OTC) anticaries drugs, which are products designed to help prevent cavities. This monograph outlines the conditions under which these topical tooth products are considered safe and effective. The main active ingredient allowed by the monograph is sodium fluoride, at a specific concentration range for gels, pastes, and powders. This regulation helps ensure that consumers have access to cavity-fighting toothpastes with the appropriate amount of fluoride for safe and effective use.

Anticaries – Active Ingredients and OTC Monograph Number

Active Ingredients	OTC Monograph Number
Sodium fluoride	M021.10 (Part 355)
Sodium monofluorophosphate	M021.10 (Part 355)
Stannous fluoride	M021.10 (Part 355)

These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.