Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Products Containing Diphenhydramine Citrate or Diphenhydramine Hydrochloride; Enforcement Policy

The Food and Drug Administration (FDA) is issuing a final rule, and a statement of its enforcement policy, providing for the use of diphenhydramine citrate or diphenhydramine hydrochloride as an antitussive and an antihistamine for treating concurrent symptoms in either single-ingredient or combination drug products. The agency will include the permitted combination products that may include diphenhydramine citrate or diphenhydramine hydrochloride in the final monograph for over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products. The OTC marketing of combination drug products containing diphenhydramine citrate or diphenhydramine hydrochloride is being permitted pending completion under the OTC drug review of the final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.