4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2422]
Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and
Antirheumatic Drug Products for Over-the-Counter Human Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability on its
website of the proposed administrative order (proposed order) entitled “Amending Over-theCounter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
for Over-the-Counter Human Use.”
DATES: Submit electronic comments on the administrative order by [INSERT DATE 45 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].
ADDRESSES: Instructions for submitting comments are contained in the proposed order
OTC000035. Comments must be submitted electronically on or before [INSERT DATE 45
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Comments
submitted after this time will not be considered.
FOR FURTHER INFORMATION CONTACT: Helen Lee, Center for Drug Evaluation and
Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-0138.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing the proposed administrative order (proposed order) to amend the
requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-thecounter (OTC) human use (OTC IAAA drug products), as currently described in Over-the-

Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
for Over-the-Counter Human Use (OTC Monograph M013), as set forth in the Final
Administrative Order OTC000035. FDA is issuing the proposed order pursuant to section
505G(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(1)).
OTC Monograph M013 describes the conditions under which over-the-counter (OTC)
internal analgesic, antipyretic, and antirheumatic drug products (OTC IAAA drug products) are
generally recognized as safe and effective. OTC Monograph M013 is set forth in Final
Administrative Order OTC000035, which was deemed established by sections 505G(b)(8) and
505G(k)(2)(B) of the FD&C Act, and was effective upon enactment of the Coronavirus Aid,
Relief, and Economic Security Act (Pub. L. 116-136) on March 27, 2020. The conditions
described in OTC Monograph M013, as set forth in final order(s), may be amended, revoked, or
otherwise modified in accordance with the procedures of section 505G(b) of the FD&C Act.
The proposed order, if finalized, will amend Final Administrative Order 000035 (as set
forth in the Order), to require addition of a warning to the labeling of OTC IAAA drug products
containing acetaminophen. The warning would alert consumers that the use of acetaminophen
may cause severe skin reactions. This proposed order also includes minor stylistic and formatting
changes to improve the readability and presentation of OTC Monograph M013, including
removing references to historical Federal Register documents because OTC monographs are no
longer modified through notice and comment rulemaking.
The proposed order can be accessed on the OTC Monographs@fda portal at
https://dps.fda.gov/omuf. FDA established this IT system with a web portal that can be accessed
through FDA’s website. OTC Monographs@FDA provides a resource for the public to view
Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs
and view OTC Monographs. OTC Monographs@FDA also facilitates the ability for the public to
submit, search, and view comments and data for Proposed and Interim Final Administrative

Orders, except if otherwise specified. The proposed order contains instructions for commenting
on the proposed order.
II. Paperwork Reduction Act of 1995
The proposed order is issued under section 505G(b)(1) of the FD&C Act. Under section
505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (Chapter 35 of title 44, United
States Code) does not apply to collections of information made under section 505G of the FD&C
Act. Therefore, clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required for collections of information, if any, in a final order
issued under section 505G that results from this proposed order.

Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13228 Filed: 6/13/2024 8:45 am; Publication Date: 6/14/2024]