MLRagent
Rules/name ingredient/US-NAME-025

Established name outside running text must be at least half the proprietary name's size

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

Rule

When the proprietary name appears outside the running text (e.g., in a headline), the established name in that same section must be printed at least half as large as the proprietary name there.

Check

Within each non-running-text element (headline, tagline, etc.) where the proprietary name appears, measure the established name's letter size against the proprietary name's letter size and confirm it is at least half as large.

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.

… 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 interprets this type-size requirement to relate to actual size, not point size, of uppercase and lowercase letters in the proprietary and established names. For example, in situations when the established name is required to be printed in letters at least half as large as the letters of the proprietary name, FDA recommends that the smallest…
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)
Version
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.