Combination products: active ingredients should be placed directly right of or below proprietary name

DisputedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

This recommendation applies only to prescription drug promotion, not over-the-counter products. For a product with two or more active ingredients in the situations described in Section III (no single established name corresponding to the proprietary name, or a proprietary name covering a combination of active ingredients across more than one preparation), FDA recommends placing the active ingredients either directly to the right of or directly below the proprietary name.

Check

Confirm the piece is prescription drug promotion involving a product with two or more active ingredients in one of the Section III situations. Check the position of the active-ingredient information relative to the proprietary name; flag placements other than directly right or directly below.

Escalate when

Reviewer cannot tell whether the active-ingredient listing's offset or spacing still counts as directly right of or directly below the proprietary name.

Where this comes from

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

… proprietary name or designation. The prominence of this listing of active ingredients shall bear a reasonable relationship to the prominence of the proprietary name and the relationship between such proprietary name or designation, and the listing of active ingredients shall be made clear by use of such phrase as "brand of", preceding the listing of active ingredients. (Emphasis added) In both of these situations, FDA recommends that the active ingredients be placed either directly to the right of or directly below the proprietary name. FDA also recommends that the proprietary name and the required information regarding the active ingredients not be separated Contains Nonbinding Recommendations by placement of intervening matter that would in any way detract from, obfuscate, or de-emphasize the active ingredients of the product or obscure the relationship between the proprietary name and the active ingredients. For example, FD…

Open the original at page 9 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

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: Section III says 'In both of these situations, FDA recommends that the active ingredients be placed either directly to the right of or directly below the proprietary name.'
- Not overstated in force: the rule preserves 'FDA recommends' and the severity is 'warning', which is the right treatment for a non-binding recommendation. Authority 'guidance' is correct here — unlike the neighbouring rules, this sentence is FDA's own recommendation, not quoted regulatory text.
- Scope is wrong: the source sentence begins 'In both of these situations', meaning the two Section III cases (a product with two or more active ingredients having no single corresponding established name, and a proprietary name covering a combination of active ingredients present in more than one preparation with no corresponding established name). The rule statement drops that condition entirely, so as written it reads as a general placement recommendation. Only the title carries the limit, and a reviewer applying the rule text alone could apply it to single-ingredient material, where Section II.A's separate recommendation about the established name governs.
- Determinism 'deterministic' is acceptable: the check is positional — is the active-ingredient information directly to the right of or directly below the proprietary name — rather than a question of impression or adequacy.
- Atomic: the two acceptable placements are alternatives within a single positional requirement, not bundled requirements.
- Locator 'Section III' is correct.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: Section III states "In both of these situations, FDA recommends that the active ingredients be placed either directly to the right of or directly below the proprietary name." This is the guidance speaking in its own voice, not a quoted regulation, so it properly belongs to this source.
- Not overstated: both the title ("should be placed") and the rule text preserve the recommendation framing, and severity "warning" matches a non-binding recommendation. The rule correctly carries the Section III scope (two or more active ingredients with no single corresponding established name) and the prescription-drug-only limit from footnote 3 in prose, which is the only place the fixed scoping vocabulary allows it.
- Atomic: one placement recommendation with two permitted positions is a single checkable requirement, not a bundle.
- Determinism is wrong. "Directly to the right of or directly below" is neither a presence/absence test nor a literal match: in a real layout a reviewer must judge whether an offset, wrapped, or loosely spaced listing still counts as "directly" right of or below the proprietary name. That is a layout judgment, and the guidance itself frames placement alongside prominence factors ("typography, layout, contrast").
- Locator "Section III" is correct and the quote is a complete sentence.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source's actual sentence is 'In both of these situations, FDA recommends that the active ingredients be placed either directly to the right of or directly below the proprietary name.' The quote drops the lead-in 'In both of these situations,' which is what limits the recommendation to the two Section III scenarios. Without it, the quote reads as a general recommendation for all products.
- The rule text correctly restores that scope (no single established name; a proprietary name covering a combination of active ingredients present in more than one preparation). It keeps 'recommends', and it limits the rule to prescription drugs, consistent with footnote 3 (the guidance does not apply to OTC drugs). The title uses 'should'. The rule is not overstated.
- Warning severity suits a non-binding placement recommendation. Judgment is defensible given the escalation about offset and spacing.

Nearby rules

US-NAME-048 US-NAME-050