21 CFR 201.61
Statement of identity
21 CFR 201.61 is the regulation titled “Statement of identity” in 21 CFR Part 201, Labeling. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 6 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 201.61 most often, as written in the letters.
- 1 letterCleansepure is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because the label fails to bear a complete statement of identity as required under 21 CFR 201.61
The regulation
Read the text of 21 CFR 201.61 (eCFR, as of Sep 1, 2026)
(a) The principal display panel of an over-the-counter drug in package form shall bear as one of its principal features a statement of the identity of the commodity.
(b) Such statement of identity shall be in terms of the established name of the drug, if any there be, followed by an accurate statement of the general pharmacological category(ies) of the drug or the principal intended action(s) of the drug. In the case of an over-the-counter drug that is a mixture and that has no established name, this requirement shall be deemed to be satisfied by a prominent and conspicuous statement of the general pharmacological action(s) of the mixture or of its principal intended action(s) in terms that are meaningful to the layman. Such statements shall be placed in direct conjunction with the most prominent display of the proprietary name or designation and shall employ terms descriptive of general pharmacological category(ies) or principal intended action(s); for example, “antacid,” “analgesic,” “decongestant,” “antihistaminic,” etc. The indications for use shall be included in the directions for use of the drug, as required by section 502(f)(1) of the act and by the regulations in this part.
(c) The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 201.61.
- 21 CFR 201.128Meaning of “intended uses”6 letters cite both
- 21 CFR 330.1General conditions for general recognition as safe, effective and not misbranded3 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
- 21 CFR 211.165Testing and release for distribution2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2 letters cite both
- 21 CFR 201.10Drugs; statement of ingredients1 letter cites both
- 21 CFR 207.41Who must list drugs and what drugs must they list?1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 201.61 that FDA posted most recently.
- DrugsView Aromas Para El Alma S.A.Hand sanitizer and antibacterial spray drug productsIssuedSep 10, 2024PostedSep 17, 2024
- DrugsView Aire-Master of America, Inc.Aire-Master Foaming Hand Sanitizer (2 and 64 fl oz) and Aire-Master Foaming Hand Sanitizer with AloeIssuedMay 23, 2022PostedJun 7, 2022
- DrugsView Maquiladora Miniara SA de CVShine and clean Hand Sanitizer GelIssuedDec 15, 2021PostedDec 21, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.