FDA Registration for Anti-Dandruff Drug Products

Anti-dandruff shampoos containing pyrithione zinc, selenium sulfide, coal tar, etc. are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration and listing.

OTC MonographDrug Facts Labeling21 CFR Part 207Since 2009

FDA Requirements for Anti-Dandruff Drug Products

Anti-dandruff shampoos are regulated as OTC drugs. Permitted active ingredients include pyrithione zinc (0.3–2%), selenium sulfide (1%), and coal tar (0.5–5%).

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

The Food and Drug Administration (FDA) outlines specific regulations for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis treatments through a monograph system. This system, designated as OTC Monograph M032, dictates which ingredients are generally recognized as safe and effective for these conditions. Common ingredients approved by M032 include coal tar, salicylic acid, selenium sulfide, and pyrithione zinc at specified concentrations. Each product’s labeling must adhere to the monograph’s guidelines, including directions for use and warnings. This system ensures that these OTC products meet safety and efficacy standards for managing these scalp conditions.

Active ingredients for the control of dandruff

Active Ingredients	OTC Monograph Number
Coal tar, 0.5 to 5 percent	M032.10 (Part 358)
Pyrithione zinc, 0.3 to 2 percent when formulated to be applied and then washed off after brief exposure	M032.10 (Part 358)
Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp	M032.10 (Part 358)
Salicylic acid, 1.8 to 3 percent	M032.10 (Part 358)
Selenium sulfide, 1 percent	M032.10 (Part 358)
Selenium sulfide, micronized, 0.6 percent	M032.10 (Part 358)
Sulfur, 2 to 5 percent	M032.10 (Part 358)

Active ingredients for the control of seborrheic dermatitis

Active Ingredients	OTC Monograph Number
Coal tar, 0.5 to 5 percent	M032.10 (Part 358)
Pyrithione zinc, 0.95 to 2 percent when formulated to be applied and then washed off after brief exposure	M032.10 (Part 358)
Pyrithione zinc, 0.1 to 0.25 percent when formulated to be applied and left on the skin or scalp	M032.10 (Part 358)
Salicylic acid, 1.8 to 3 percent	M032.10 (Part 358)
Selenium sulfide, 1 percent	M032.10 (Part 358)

Active ingredients for the control of psoriasis.

Active Ingredients	OTC Monograph Number
Coal tar, 0.5 to 5 percent	M032.10 (Part 358)
Salicylic acid, 1.8 to 3 percent	M032.10 (Part 358)

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.