MLRagent
Rules/name ingredient/US-NAME-032

Print: established name required once in running text when proprietary name only in text

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

Rule

In traditional print materials, if the proprietary name appears only within running text (not featured), the established name is required to accompany it at least once in that running text.

Check

Check print running text where the proprietary name is not featured; confirm the established name appears at least once in that running text.

Where this comes from

Section II.D.1 · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… accompanies the proprietary name at least once per page or spread where the proprietary name most prominently appears. For example, if the established name follows the proprietary name in a headline, FDA does not intend to object if the established name does not also follow the proprietary name in sub-headlines, appear in the running text on the same page or spread, or appear in columns on the same page or spread. If the proprietary name is not featured but is only part of the running text, the established name is required to accompany the proprietary name at least once in the running text. If the running text spans more than one page or spread, FDA recommends that the established name accompany the proprietary name at least once per page or spread. The regulations in 21 CFR 201.10(g)(1) and 202.1(b)(1) include information regarding the frequency of the proprietary and established names if columns are used in a promotional labeling piece or advertisement (e.g., a newspaper advertisement). FDA interpre…
Open the original at page 8 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.