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Code of Federal Regulations › Title 21 › Part 341

Part 341 — Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use

Current through Sep 8, 2026

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

Editorial Note: Nomenclature changes to part 341 appear at 69 FR 13717, Mar. 24, 2004.

Sections

  • § 341.1 Scope.
  • § 341.3 Definitions.
  • § 341.12 Antihistamine active ingredients.
  • § 341.14 Antitussive active ingredients.
  • § 341.16 Bronchodilator active ingredients.
  • § 341.18 Expectorant active ingredient.
  • § 341.20 Nasal decongestant active ingredients.
  • § 341.40 Permitted combinations of active ingredients.
  • § 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product).
  • § 341.72 Labeling of antihistamine drug products.
  • § 341.74 Labeling of antitussive drug products.
  • § 341.76 Labeling of bronchodilator drug products.
  • § 341.78 Labeling of expectorant drug products.
  • § 341.80 Labeling of nasal decongestant drug products.
  • § 341.85 Labeling of permitted combinations of active ingredients.
  • § 341.90 Professional labeling.
Not legal advice. The eCFR is an editorially compiled, unofficial edition of the CFR; official editions are published by the Office of the Federal Register on govinfo.gov. About OpenCFR · Interpretation letters · Privacy