[6/14/2024] Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-counter (OTC) monograph drug products containing acetaminophen.

Based on a comprehensive scientific review of available data, FDA determined that acetaminophen continues to be associated with the risk of rare but serious skin reactions. This proposed order, if finalized, would require drug companies to add a warning to the labeling. The proposed warning below, which is the same as the warning language FDA previously recommended in a 2017 guidance, would alert consumers that the use of acetaminophen may cause severe skin reactions.

FDA is seeking comments on this proposed order and instructions on how to submit comments are found below. After a review of comments, FDA will issue a final order. FDA has communicated about this safety issue in the past.

• In August 2013, FDA issued a Drug Safety Communication informing the public that use of acetaminophen is associated with a risk of rare but serious skin reactions.
• In 2017, FDA issued final Guidance for Industry titled, Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reaction. The 2017 guidance recommended the addition of language in product labeling warning consumers that acetaminophen may cause severe skin reactions,

“Today’s actions represent important milestones in FDA’s implementation of new authorities provided by Congress as part of OTC Monograph Reform,” said Theresa Michele, M.D., director of the Office of Nonprescription Drugs in FDA’s Center for Drug Evaluation and Research. “Today’s proposed order helps to ensure the safety and effectiveness of OTC drugs in our marketplace.”

Specifically, through Proposed Administrative Order (OTC000035): Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use, the agency proposes to amend the conditions described in OTC Monograph M013¹ to require OTC oral analgesic, antipyretic, and antirheumatic (IAAA) drug products containing acetaminophen to include the above warning on the product labeling about serious skin reactions. This is also the first time the public can use FDA’s web portal, OTC Monographs @ FDA to submit feedback.

How to submit comments
Currently, the commenting function is unavailable due to a technical issue. As a result, the comment period will be extended beyond July 29, 2024. Please check OTC Monographs @ FDA for any updates.

To view the proposed order and instructions for submitting a comment on the proposed order, visit OTC Monographs@FDA.

Comments must be submitted electronically. Submit comments electronically to Order ID OTC000035 for “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.”

Additional information

• For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA portal.
• For a non-binding list of planned monograph activities that FDA intends to initiate over the ensuing 3 years, see the annual monograph forecast.
• For more information about acetaminophen, visit FDA’s consumer page and questions and answers page on the topic.

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¹ OTC Monograph M013 describes the conditions under which OTC IAAA drug products are generally recognized as safe and effective (GRASE). OTC monograph drug products may be marketed under the Federal Food, Drug, and Cosmetic Act without an approved drug application if they meet the conditions in the relevant OTC monograph(s) and other applicable requirements.