Part 201 — Labeling
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
Editorial Note: Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.
Sections
- § 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.
- § 201.2 Drugs and devices; National Drug Code numbers.
- § 201.5 Drugs; adequate directions for use.
- § 201.6 Drugs; misleading statements.
- § 201.10 Drugs; statement of ingredients.
- § 201.15 Drugs; prominence of required label statements.
- § 201.16 Drugs; Spanish-language version of certain required statements.
- § 201.17 Drugs; location of expiration date.
- § 201.18 Drugs; significance of control numbers.
- § 201.19 Drugs; use of term “infant”.
- § 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.
- § 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.
- § 201.22 Prescription drugs containing sulfites; required warning statements.
- § 201.23 Required pediatric studies.
- § 201.24 Labeling for systemic antibacterial drug products.
- § 201.25 Bar code label requirements.
- § 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.
- § 201.50 Statement of identity.
- § 201.51 Declaration of net quantity of contents.
- § 201.55 Statement of dosage.
- § 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
- § 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).
- § 201.58 Waiver of labeling requirements.
- § 201.60 Principal display panel.
- § 201.61 Statement of identity.
- § 201.62 Declaration of net quantity of contents.
- § 201.63 Pregnancy/breast-feeding warning.
- § 201.64 Sodium labeling.
- § 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.
- § 201.67 Labeling requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
- § 201.70 Calcium labeling.
- § 201.71 Magnesium labeling.
- § 201.72 Potassium labeling.
- § 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1).
- § 201.100 Prescription drugs for human use.
- § 201.105 Veterinary drugs.
- § 201.115 New drugs or new animal drugs.
- § 201.116 Drugs having commonly known directions.
- § 201.117 Inactive ingredients.
- § 201.119 In vitro diagnostic products.
- § 201.120 Prescription chemicals and other prescription components.
- § 201.122 Drugs for processing, repacking, or manufacturing.
- § 201.125 Drugs for use in teaching, law enforcement, research, and analysis.
- § 201.127 Drugs; expiration of exemptions.
- § 201.128 Meaning of “intended uses”.
- § 201.129 Drugs; exemption for radioactive drugs for research use.
- § 201.130 Exemption from adequate directions for use for a nonprescription drug product with an additional condition for nonprescription use (ACNU).
- § 201.150 Drugs; processing, labeling, or repacking.
- § 201.161 Medical gases.
- § 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.
- § 201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
- § 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.
- § 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.
- § 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.
- § 201.304 Tannic acid and barium enema preparations.
- § 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.
- § 201.306 Potassium salt preparations intended for oral ingestion by man.
- § 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.
- § 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.
- § 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.
- § 201.310 Phenindione; labeling of drug preparations intended for use by man.
- § 201.311 [Reserved]
- § 201.312 Magnesium sulfate heptahydrate; label declaration on drug products.
- § 201.313 Estradiol labeling.
- § 201.314 Labeling of drug preparations containing salicylates.
- § 201.315 Over-the-counter drugs for minor sore throats; suggested warning.
- § 201.316 Drugs with thyroid hormone activity for human use; required warning.
- § 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.
- § 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.
- § 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.
- § 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.
- § 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.
- § 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.
- § 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.
- § 201.328 Labeling of medical gas containers.
- Appendix A to Part 201—Examples of Graphic Enhancements Used by FDA