Oral Health Care Products

The FDA establishes guidelines for over-the-counter (OTC) oral health care drugs through a document called an OTC monograph. This monograph outlines the conditions under which these medications are considered safe and effective for their intended use. Essentially, it sets the standards that OTC oral care products must meet to be sold over the counter without a prescription. The monograph covers various purposes, including pain relief, antiseptic properties, and reduction of plaque and gingivitis. Following this guideline helps ensure that consumers have access to safe and effective oral care products for common concerns.

Oral Health Care Products - Active Ingredients and OTC Monograph Number

M022.12 Anesthetic/analgesics
Active Ingredients OTC Monograph Number
BenzocaineM022.12 (Part 356)
Benzyl alcoholM022.12 (Part 356)
Butacaine sulfateM022.12 (Part 356)
Dyclonine hydrochlorideM022.12 (Part 356)
HexylresorcinolM022.12 (Part 356)
MentholM022.12 (Part 356)
Phenol preparations (phenol and/or phenolate sodium)M022.12 (Part 356)
Salicyl alcoholM022.12 (Part 356)
M022.14 Astringents
Active Ingredients OTC Monograph Number
AlumM022.14 (Part 356)
Zinc chlorideM022.14 (Part 356)
M022.16 Debriding agent/oral wound cleansers
Active Ingredients OTC Monograph Number
Carbamide peroxide in anhydrous glycerin M022.16 (Part 356)
Hydrogen peroxideM022.16 (Part 356)
Sodium bicarbonateM022.16 (Part 356)
Sodium perborate monohydrateM022.16 (Part 356)
M022.18 Demulcents
Active Ingredients OTC Monograph Number
Elm barkM022.18 (Part 356)
GelatinM022.18 (Part 356)
GlycerinM022.18 (Part 356)
PectinM022.18 (Part 356)
M022.20 Oral mucosal protectants
Active Ingredients OTC Monograph Number
Compound benzoin tincture, USP XIX.3M022.20 (Part 356)
Benzoin tincture, USP XVM022.20 (Part 356)
M022.22 Tooth desensitizers
Active Ingredients OTC Monograph Number
Potassium nitrateM022.22 (Part 356)