FDA Registration for OTC Oral Health Drug Products
OTC oral health drug products (toothache gels, antiseptic mouthwash, canker sore treatments) are regulated as OTC Monograph drugs by FDA — requiring establishment registration and listing.
FDA Requirements for OTC Oral Health Drug Products
OTC oral health drug products include toothache analgesics (benzocaine), antiseptic mouthwashes, and oral wound care products. These are regulated as OTC drugs by FDA.
Note: Cosmetic mouthwashes (breath fresheners only) are cosmetics, not drugs.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
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 |
|---|---|
| Benzocaine | M022.12 (Part 356) |
| Benzyl alcohol | M022.12 (Part 356) |
| Butacaine sulfate | M022.12 (Part 356) |
| Dyclonine hydrochloride | M022.12 (Part 356) |
| Hexylresorcinol | M022.12 (Part 356) |
| Menthol | M022.12 (Part 356) |
| Phenol preparations (phenol and/or phenolate sodium) | M022.12 (Part 356) |
| Salicyl alcohol | M022.12 (Part 356) |
M022.14 Astringents
| Active Ingredients | OTC Monograph Number |
|---|---|
| Alum | M022.14 (Part 356) |
| Zinc chloride | M022.14 (Part 356) |
M022.16 Debriding agent/oral wound cleansers
| Active Ingredients | OTC Monograph Number |
|---|---|
| Carbamide peroxide in anhydrous glycerin | M022.16 (Part 356) |
| Hydrogen peroxide | M022.16 (Part 356) |
| Sodium bicarbonate | M022.16 (Part 356) |
| Sodium perborate monohydrate | M022.16 (Part 356) |
M022.18 Demulcents
| Active Ingredients | OTC Monograph Number |
|---|---|
| Elm bark | M022.18 (Part 356) |
| Gelatin | M022.18 (Part 356) |
| Glycerin | M022.18 (Part 356) |
| Pectin | M022.18 (Part 356) |
M022.20 Oral mucosal protectants
| Active Ingredients | OTC Monograph Number |
|---|---|
| Compound benzoin tincture, USP XIX | M022.20 (Part 356) |
| Benzoin tincture, USP XV | M022.20 (Part 356) |
M022.22 Tooth desensitizers
| Active Ingredients | OTC Monograph Number |
|---|---|
| Potassium nitrate | M022.22 (Part 356) |
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.
OTC Oral Health Drug Products — FAQs
Is mouthwash a drug or cosmetic?
Mouthwash that makes antiseptic or therapeutic claims (such as reducing plaque or treating gum disease) is classified as an OTC drug. Conversely, products that make only cosmetic claims (such as breath freshening) and contain no active ingredients are regulated as cosmetics.
Is benzocaine toothache gel a drug?
Ready to Register Your OTC Oral Health Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for otc oral health products manufacturers worldwide.
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