Established name should sit directly right of or below proprietary name

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

Rule

FDA recommends placing the established name either directly to the right of or directly below the proprietary name.

Check

Confirm the established name's position relative to the proprietary name; flag placements other than directly right or directly below as deviating from FDA's recommended practice.

Where this comes from

Section II.A · page 6. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…he prescription drug and biological products is proposed by the applicant and undergoes review and final approval by FDA. Contains Nonbinding Recommendations proprietary name or designation and the established name shall be made clear by use of a phrase such as "brand of" preceding the established name, by brackets surrounding the established name, or by other suitable means. (Emphasis added) FDA recommends that the established name be placed either directly to the right of or directly below the proprietary name. FDA also recommends that the proprietary name and the established name not be separated by placement of intervening matter that would in any way detract from, obfuscate, or de-emphasize the established name of the product or obscure the relationship between the proprietary name and the established name. For example, FDA recommends that the proprietary and established names not be separated by intervening matter, su…

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.

Applies when

Naturepromotional

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is verbatim from Section II.A and the rule statement is a faithful, unembellished restatement of it.
- Correctly preserved as non-binding. The rule statement keeps 'FDA recommends', authority is 'guidance', severity is 'warning' rather than blocker, and the check characterises a deviation as 'deviating from FDA's recommended practice' rather than as a violation. This is precisely the handling the source's own 'the use of the word should ... means suggested or recommended, but not required' paragraph calls for.
- Determinism 'deterministic' is right: whether the established name sits directly to the right of or directly below the proprietary name is settled by observing its position, with no adequacy or impression judgment.
- Atomic: the two acceptable positions are alternatives within a single positional test, not independently checkable requirements.
- The same recommendation is repeated in Section III for multi-ingredient products (with active ingredients in place of the established name), so leaving applies_when unrestricted as to product type is not a fault here.
- Severity 'warning' is defensible for a recommendation whose breach does not itself violate the regulation.

Nearby rules

US-NAME-020 US-NAME-022