U.S. FDA proposes ending use of popular decongestant present in cold medicines

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The U.S. Food and Drug Administration proposed to remove oral phenylephrine, widely used in cold and cough syrups, as an active ingredient in over-the-counter drugs for nasal congestion on Thursday, November 7, 2024.

An agency review of the available data determined oral phenylephrine is not effective against nasal congestion, the health regulator said.

Last year, an outside panel of experts unanimously voted against the effectiveness of orally administered phenylephrine as a nasal decongestant, adding that no more trials were required to prove otherwise.

Oral phenylephrine is a major component of popular products such as Benadryl, Advil and Tylenol.

For now, companies may continue to market drug products containing the ingredient as a nasal decongestant, the FDA said.