FDA Registration for OTC Internal Analgesic Products

OTC pain relievers (acetaminophen, aspirin, etc.) are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.

OTC MonographDrug Facts Required21 CFR Part 207Since 2009

FDA Requirements for OTC Internal Analgesic Products

OTC internal analgesic drug products include oral pain relievers. Permitted active ingredients include acetaminophen, aspirin, carbaspirin calcium, and magnesium salicylate.

These are among the most commonly registered OTC drug products. All manufacturers must register with FDA as drug establishments and list each product.

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

An OTC monograph, established by the FDA, outlines the conditions under which certain internal analgesic drugs are considered safe and effective for self-treatment. These drugs, like acetaminophen or aspirin, typically relieve pain and fever. The monograph dictates what ingredients are allowed, proper dosage, and necessary warnings on the label. This ensures consumers have access to safe and effective pain relief medications without a prescription, while also being informed of potential risks like stomach bleeding or allergic reactions.

Active Ingredients	OTC Monograph Number
Acetaminophen	M013.10 (Part 343)
Aspirin ingredients	M013.10 (Part 343)
Carbaspirin calcium	M013.10 (Part 343)
Choline salicylate	M013.10 (Part 343)
Magnesium salicylate	M013.10 (Part 343)
Sodium salicylate	M013.10 (Part 343)

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.