FDA

FDA proposes removal of oral phenylephrine from OTC nasal decongestants

November 7, 2024

FDA is proposing removing oral phenylephrine from OTC monograph drug products used for nasal congestion relief, following a comprehensive review that found the product to be ineffective. This proposal does not affect the safety profile of oral phenylephrine or its use in combination with other active ingredients, nor does it impact phenylephrine nasal sprays.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” said Theresa Michele, M.D., director of the Office of Nonprescription Drug Products in CDER. “Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms.”

The agency is currently seeking public comments before issuing a final order. If, after considering the comments, FDA concludes that oral phenylephrine is not effective as a nasal decongestant, it will issue a final order removing oral phenylephrine from the OTC monograph. As a result, drug products could no longer contain oral phenylephrine as a nasal decongestant.

Source:

FDA. (2024, November 7). FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review. [News release]. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after