21 CFR 201.66 · OTC Drug Facts

Your OTC label's Drug Facts panel, laid out right.

Fill in a guided form — active ingredients, uses, warnings, directions — and get a print-ready Drug Facts panel PDF built in the fixed heading order, with the box border, graded rules, and bold headings the format requires.

  • Runs 100% in your browser
  • Canonical 201.66 heading order
  • Print-ready PDF
Drug Facts builder LOCAL · NO UPLOAD
Active ingredients
Each ingredient + amount goes on the left; its purpose is right-aligned in the panel.
Warnings
Questions?

Free: panel with a diagonal DRAFT watermark · $49: clean, unwatermarked panels. This is a drafting aid — verify every panel against 21 CFR 201.66 before compliance use.

All rendering happens locally in your browser. Nothing is uploaded.

Built to the format Fixed heading order · Box / barbell border · Graded rules · 6pt type floor · Right-aligned Purpose column
How it works

From a plain form to a compliant-looking panel.

You supply the content. The tool enforces the 21 CFR 201.66 structure and graphics so the layout is right the first time.

01

Enter your content

Active ingredients with amounts and purposes, uses, the ordered warnings, directions, other information, inactive ingredients, and a Questions? phone number.

02

We enforce the order

The builder assembles the fixed heading sequence, pairs each active ingredient with its purpose, sorts inactive ingredients alphabetically, and always includes Keep out of reach of children.

03

Export a print-ready PDF

Rendered with a box border, graded rules, bold full-width headings, and a 6pt minimum type size. Overflow continues onto a "Drug Facts (continued)" page.

Example

Same content, free draft vs. full panel.

The free tier stamps a diagonal DRAFT watermark. The full version renders the same panel clean.

Free — DRAFT watermark
Drug Facts
Active ingredient (in each tablet)Purpose
Ibuprofen 200 mgPain reliever/fever reducer
Uses

temporarily relieves minor aches and pains

Warnings
Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Full version — clean
Drug Facts
Active ingredient (in each tablet)Purpose
Ibuprofen 200 mgPain reliever/fever reducer
Uses

temporarily relieves minor aches and pains

Warnings
Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Build your own panel

The rendered PDF uses the same fixed order and graded rules shown here, at a 6pt minimum type size.

Privacy & responsibility

Your formula never leaves your browser.

There is no upload and no account. The panel is assembled and rendered on your device. And we are direct about what this tool is: a drafting aid, not a compliance sign-off.

100% client-side

Your ingredient list, warnings, and directions are processed in the browser. The only network calls are the optional license check.

Structure enforced

Headings render in the fixed 201.66 order with the box border, graded rules, and 6pt type floor built in — you cannot accidentally reorder them.

Draft, not compliance

This is a layout tool. It does not verify your dosing, claims, or warnings. Have a qualified regulatory person review every panel before you print or ship.

Pricing

One-time price. No subscription.

Try it free with a DRAFT watermark. Pay once to render clean panels.

Free

$0
  • Full guided builder
  • Print-ready PDF export
  • Diagonal DRAFT watermark on every page
Start free
Full version

One-time

$49 once
  • Clean, unwatermarked panels
  • Same 201.66 structure & graphics
  • Multi-page "continued" overflow
  • Generous credit pack, no expiry

Questions

Straight answers.

Does this make my label FDA-compliant?

No. Drug Facts Panel Maker lays out your content in the 21 CFR 201.66 format — the fixed heading order, the box border, the graded rules, the type-size floor. It does not verify that your dosing, uses, warnings, or claims are correct or complete. Every panel is a draft you must verify with a qualified regulatory person before compliance use.

What is 21 CFR 201.66?

It is the FDA regulation that defines the content and format of the OTC "Drug Facts" panel: the required headings, their order, and the graphic requirements (bold headings, horizontal barbells/rules, a bounding box, and a minimum type size). This tool follows that graphic structure.

What does the free version produce?

A complete panel PDF with a diagonal "DRAFT — NOT FOR COMPLIANCE USE" watermark across every page. The paid version renders the exact same panel without the watermark.

Which sections are required?

The builder requires at least one active ingredient with a purpose, the Uses section, the Directions section, and the Keep out of reach of children statement. Other sections render only when you provide content, in the canonical order.

Is my formulation uploaded anywhere?

No. Everything runs in your browser. The panel is assembled and the PDF is rendered on your device. The only server calls are for the optional license check when you enter a key.

What if my panel is too long for one page?

It flows onto additional pages, each carrying a "Drug Facts (continued)" title and the same box and rules, so nothing is cut off.

Lay out your Drug Facts panel now. Verify before you ship.

Drug Facts Panel Maker produces DRAFT label panels for layout. It is software, not regulatory advice, and makes no representation of FDA compliance. Verify every panel against 21 CFR 201.66 with a qualified person before use.