FDA Registration for Corn & Callus Remover Products

Corn and callus remover products containing salicylic acid are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.

OTC MonographSalicylic AcidDrug Facts RequiredSince 2009

FDA Requirements for Corn & Callus Remover Products

Corn and callus remover drug products are regulated as OTC drugs. Salicylic acid (12–40%) is the active ingredient permitted under the OTC Corn and Callus Remover Monograph.

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

The U.S. Food and Drug Administration (FDA) regulates over-the-counter (OTC) corn and callus remover products through a specific monograph, designated as M030. This monograph ensures these products are safe and effective for their intended use. According to M030, an acceptable corn and callus remover will be a topical treatment containing salicylic acid within a certain concentration range. The monograph dictates two acceptable dosage forms: a plaster vehicle containing 12 to 40% salicylic acid, or a collodion-like solution with 12 to 17.6% salicylic acid.

Corn and Callus Remover – Active Ingredients and OTC Monograph Number

Active Ingredients	OTC Monograph Number
Salicylic acid 12 to 40 percent in a plaster vehicle	M030.10 (Part 358)
Salicylic acid 12 to 17.6 percent in a collodion-like vehicle	M030.10 (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.