FDA Registration for External Analgesic Drug Products

External analgesic products (topical pain relief creams, gels, ointments etc.) containing menthol, methyl salicylate, or capsaicin are regulated as OTC Monograph drugs by FDA — requiring establishment registration and listing.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for External Analgesic Drug Products

External analgesic OTC drug products include topical pain relief creams, gels, ointments etc. Permitted active ingredients include menthol (1.25–16%), methyl salicylate (10–60%), and capsaicin (0.025–0.25%).

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

OTC (over-the-counter) external analgesic drugs are topical medications applied to the skin for pain relief. The U.S. Food and Drug Administration (FDA) oversees these products through a monograph system, establishing which ingredients are safe and effective at specific concentrations. This ensures consistency and quality among these medications. Common examples of OTC external analgesics include creams containing menthol or lidocaine to numb pain.

M017.10 Analgesic, anesthetic, and antipruritic

Active Ingredients	OTC Monograph Number
(a) Amine and “caine”-type local anesthetics
(1) Benzocaine 5 to 20%	M017.10 (Part 348)
(2) Butamben picrate 1%	M017.10 (Part 348)
(3) Dibucaine 0.25 to 1%	M017.10 (Part 348)
(4) Dibucaine hydrochloride 0.25 to 1%	M017.10 (Part 348)
(5) Dimethisoquin hydrochloride 0.3 to 0.5%	M017.10 (Part 348)
(6) Dyclonine hydrochloride 0.5 to 1%	M017.10 (Part 348)
(7) Lidocaine 0.5 to 4%	M017.10 (Part 348)
(8) Lidocaine hydrochloride 0.5 to 4%	M017.10 (Part 348)
(9) Pramoxine hydrochloride 0.5 to 1%	M017.10 (Part 348)
(10) Tetracaine 1 to 2%	M017.10 (Part 348)
(11) Tetracaine hydrochloride 1 to 2%	M017.10 (Part 348)
(b) Alcohols and ketones
(1) Benzyl alcohol 10 to 33%	M017.10 (Part 348)
(2) Camphor 0.1 to 3%	M017.10 (Part 348)
((3) Camphor 3 to 10.8% when combined with phenol	M017.10 (Part 348)
(4) Camphorated metacresol (camphor 3 to 10.8% and metacresol 1 to 3.6%)	M017.10 (Part 348)
(5) Juniper tar 1 to 5%	M017.10 (Part 348)
(6) Menthol 0.1 to 1%	M017.10 (Part 348)
(7) Phenol 0.5 to 1.5%	M017.10 (Part 348)
(8) Phenol 4.7% when combined with camphor in accordance with § M017.20(a)(4)	M017.10 (Part 348)
(9) Phenolate sodium 0.5 to 1.5%	M017.10 (Part 348)
(10) Resorcinol 0.5 to 3%	M017.10 (Part 348)
(c) Antihistamines
(1) Diphenhydramine hydrochloride 1 to 2%	M017.10 (Part 348)
(2) Tripelennamine hydrochloride 0.5 to 2%	M017.10 (Part 348)
(d) Hydrocortisone preparations
(1) Hydrocortisone 0.25 to 1%	M017.10 (Part 348)
(2) Hydrocortisone acetate, equivalent to hydrocortisone, 0.25 to 1%	M017.10 (Part 348)
(e) Male genital desensitizers
(1) Benzocaine, 3 to 7.5% in a water-soluble base	M017.10 (Part 348)
(2) Lidocaine in a metered spray with approximately 10 milligrams per spray	M017.10 (Part 348)

M017.12 Counterirritant active ingredients

Active Ingredients	OTC Monograph Number
(a) Irritants that produce redness.
(1) Allyl isothiocyanate 0.5 to 5%	M017.12 (Part 348)
(2) Strong ammonia solution, diluted to contain 1 to 2.5% ammonia	M017.12 (Part 348)
(3) Methyl salicylate 10 to 60%	M017.12 (Part 348)
(4) Turpentine oil 6 to 50%	M017.12 (Part 348)
(b) Irritants that produce cooling sensation
(1) Camphor exceeding 3% to 11%	M017.12 (Part 348)
(2) Menthol 1.25 to 16%	M017.12 (Part 348)
(c) Irritants that produce vasodilation
(1) Histamine dihydrochloride 0.025 to 0.10%	M017.12 (Part 348)
(2) Methyl nicotinate 0.25 to 1%	M017.12 (Part 348)
(d) Irritants that do not produce redness
(1) Capsaicin 0.025 to 0.25%	M017.12 (Part 348)
(2) Capsicum containing 0.025 to 0.25% capsaicin	M017.12 (Part 348)
(3) Capsicum oleoresin containing 0.025 to 0.25% capsaicin	M017.12 (Part 348)

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.