November 07, 2024

Today, 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. 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.