---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chI/subchC/part201"
level: "part"
label: "Part 201"
heading: "Labeling"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chI-subchC-part201"
sections_count: 75
---

# Part 201 — Labeling

Title 21 C.F.R. — Food and Drugs › Chapter I — Food and Drug Administration, Department of Health and Human Services › Subchapter C — Drugs: General

## Contents

- [Subpart A — General Labeling Provisions](/cfr/21/chI-subchC-part201-subpartA.md)
- [Subpart B — Labeling Requirements for Prescription Drugs and/or Insulin](/cfr/21/chI-subchC-part201-subpartB.md)
- [Subpart C — Labeling Requirements for Over-the-Counter Drugs](/cfr/21/chI-subchC-part201-subpartC.md)
- [Subpart D — Exemptions From Adequate Directions for Use](/cfr/21/chI-subchC-part201-subpartD.md)
- [Subpart E — Other Exemptions](/cfr/21/chI-subchC-part201-subpartE.md)
- [Subpart F — Labeling Claims for Drugs in Drug Efficacy Study](/cfr/21/chI-subchC-part201-subpartF.md)
- [Subpart G — Specific Labeling Requirements for Specific Drug Products](/cfr/21/chI-subchC-part201-subpartG.md)