Anticaries Drug Products for Over-the-Counter Human Use; Final Monograph

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) anticaries drug products (products that aid in the prevention of dental cavities) are generally recognized as safe and effective and not misbranded. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on OTC anticaries drug products that have come to the agency's attention. This final monograph is part of the ongoing review of OTC drug products conducted by FDA.