FDA Registration for Pediculicide Drug Products

Pediculicide products for lice treatment containing pyrethrin are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration and listing.

OTC MonographDrug Facts Required21 CFR Part 207Since 2009

FDA Requirements for Pediculicide Drug Products

Pediculicide (lice treatment) products are regulated as OTC drugs by FDA. Permitted active ingredients include pyrethrin (0.17–0.33%) with piperonyl butoxide (2–4%).

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

The FDA oversees OTC lice treatments, known as pediculicide drug products, through a specific monograph designated as M031. This monograph outlines the criteria that manufacturers must follow to ensure their products are safe and effective for treating head, pubic, and body lice. M031 dictates acceptable ingredients, proper labeling with directions and warnings, and manufacturing standards. Following this monograph allows lice treatments to be sold over-the-counter without a prescription. Examples of common monograph-approved ingredients include pyrethrins, which kill lice and their eggs. If a lice treatment contains unapproved ingredients or deviates from the monograph requirements, it would be classified as a new drug.

Pediculicide – Active Ingredients and OTC Monograph Number

Active Ingredients	OTC Monograph Number
Pyrethrum extract (providing a concentration of pyrethrins of 0.17 to 0.33 percent) with piperonyl butoxide	M031.10 (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.

Pediculicide Drug Products — FAQs

Common questions about FDA registration requirements for pediculicide drug products.

Are lice treatment products regulated as drugs?

Yes. Pediculicide products containing pyrethrin are OTC drugs regulated by FDA.

What concentration of pyrethrin is allowed OTC?

Pyrethrum extract (providing a concentration of pyrethrins of 0.17 to 0.33 percent) with piperonyl butoxide is permitted in OTC lice treatment products.