MLRagent
Rules/name ingredient/US-NAME-024

Established name must be at least half size when proprietary name is enlarged in running text

AI-verifiedblockerFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

If the proprietary name appears in running text in larger type than the surrounding text, the established name must appear at least once in letters at least half as large as the most prominent presentation of the proprietary name in that running text.

Check

Measure the largest presentation of the proprietary name in running text and confirm the established name appears at least once at half that letter size or larger.

Where this comes from

21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2); Section II.B · page 6. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…also require, in general, that the proprietary and established names be presented in the same type size (21 CFR 201.10(g)(1) and 202.1(b)(1)). FDA interprets the running text to mean the body of text in a promotional piece, as distinct from headlines, taglines, logos, graphs, or pictures. When the proprietary name is presented within the running text in larger-sized type than that of the surrounding running text, the established name is required to be printed at least once in letters that are at least half as large as the letters of the most prominent presentation of the proprietary name in such running text (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)). In addition, when the proprietary name is presented outside the running text, such as in a headline, the established name is also required to be printed in letters that are at least half as large as the letters of the proprietary name within that designated section (e.g., headline) (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)). Please note that FDA inte…
Open the original at page 6 on fda.gov ↗Read our full copy →
Document
FDA guidance: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (final)
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as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved
2026-09-21 from www.fda.gov
Fingerprint
f6f78606542ef91596ef21f6…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.