OTC Drug Facts label requirements
Every over-the-counter (OTC) drug marketed in the United States must carry a standardized "Drug Facts" panel on its label. The content and format are set by FDA regulation 21 CFR 201.66. The rule exists so that a shopper can find the same information — what the active ingredient is, what it treats, when not to use it, and how to dose it — in the same place on every OTC product.
The panel is not free-form. The headings appear in a fixed order, each in a specific style, separated by graded horizontal rules and enclosed in a bounding box. If a required heading applies to your product, it must appear; you may only omit a heading that is genuinely inapplicable.
The required headings, in order, are: the title "Drug Facts"; "Active ingredient(s)" paired with a right-aligned "Purpose" column; "Uses"; "Warnings" (with its ordered sub-warnings); "Directions"; "Other information"; "Inactive ingredients"; and "Questions?" with a phone number.
Drug Facts Panel Maker lays out your content in the 21 CFR 201.66 format. It is a drafting aid, not regulatory, legal, or medical advice, and does not verify that your dosing, uses, warnings, or claims are correct. Verify every panel with a qualified regulatory person before compliance use.
Build a Drug Facts panel — free draft
The Drug Facts panel, heading by heading
- Drug Facts — the title, in the largest, boldest type at the top of the panel.
- Active ingredient(s) / Purpose — each active ingredient and its amount per dosage unit on the left, its purpose right-aligned on the same line.
- Uses — the indications the product is labeled to treat or prevent.
- Warnings — the safety information, in the fixed sub-warning order, always ending with Keep out of reach of children.
- Directions — dosing instructions, typically broken out by age group.
- Other information — storage conditions and other required statements (e.g. sodium content).
- Inactive ingredients — listed in alphabetical order.
- Questions? — a telephone number for the consumer to call, optionally with hours.
Questions
Do all OTC products need a Drug Facts panel?
Products marketed as OTC drugs — meaning they make a drug claim (treats, prevents, relieves, reduces) and contain an active drug ingredient — must carry a Drug Facts panel under 21 CFR 201.66. Cosmetics that make no drug claim do not, but a product can be both a drug and a cosmetic (for example a sunscreen moisturizer), in which case the drug portion needs the panel. Verify your product's status with a regulatory professional.
Can I reorder the headings to fit my package?
No. The heading order is fixed by the regulation. You can adjust column widths and use a horizontal (side-by-side) layout on small packages, but the sequence of headings does not change.
What happens if I leave out a required heading?
Omitting a heading that applies to your product makes the label non-compliant. You may only omit a heading that is truly inapplicable — for example, a product with no inactive ingredients would not need that heading.