The FDA has proposed removing oral phenylephrine as an active ingredient in over-the-counter nasal decongestants based on a review of available data that concluded oral phenylephrine is ineffective for this purpose.
This is not a final order. Only a final order will affect what products can be marketed; companies may continue to sell OTC products containing phenylephrine until a final order is issued. It should be noted that products containing oral phenylephrine alongside other active ingredients (like acetaminophen or dextromethorphan) may still be effective for other symptoms. The FDA is seeking public comments on this proposed order. Instructions on how to submit comments are found in the proposed order available on OTC Monographs@FDA. See the full FDA update here.
