MLRagent
Rules/name ingredient/US-NAME-040

Digital: established name once per web page where proprietary name most prominent suffices

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

For electronic and computer-based promotion, FDA does not intend to object to fewer appearances of the established name as long as it accompanies the proprietary name at least once per web page where the proprietary name most prominently appears.

Check

For each web page, identify where the proprietary name most prominently appears and confirm the established name accompanies it there at least once.

Escalate when

Reviewer is unsure which element of the web page is the most prominent display of the proprietary name, especially across different device views.

Where this comes from

Section II.D.3 · page 9. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…tary name. Under most circumstances, this is the first occurrence in the broadcast. Contains Nonbinding Recommendations 3. Electronic and Computer-Based Promotion Promotion in electronic and computer-based media also does not contain text pages like print media. However, promotion in such media often contains information or running text equivalent to many pages of traditional printed text. FDA does not intend to object to fewer appearances of the established name, provided that the established name accompanies the proprietary name at least once per web page where the proprietary name most prominently appears on the web page. However, if the proprietary name is not featured but is part of the running text, the established name is required to accompany the proprietary name at least once in the running text (21 CFR 201.10(g)(1) and 202.1(b)(1)). Columns of running text should be treated similarly to columns on the printed page. III. PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS A product with two or more active ingredients might …
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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
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FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.