November 13, 2024- The U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use. Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many OTC monograph drug products. For now, companies may continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant. This is a proposed order. Only a final order will affect what products can be marketed. The proposed order is based on effectiveness concerns, not on safety concerns.
According to the FDA, it is important to note that some products only contain oral phenylephrine as a single, active ingredient. Others contain oral phenylephrine and another active ingredient (e.g., acetaminophen or dextromethorphan), and the presence of oral phenylephrine in these medicines does not affect how other active ingredients work to treat the symptoms for which they are intended.