FDA Proposes Removal of Ineffective Oral Phenylephrine from Cold Medicines

The FDA has determined that oral phenylephrine, a common decongestant, is ineffective and is seeking public comment on its removal from over-the-counter products.

The FDA's proposal follows a unanimous advisory committee decision that oral phenylephrine does not effectively relieve nasal congestion.
Phenylephrine is found in many popular cold and allergy medications, including NyQuil, Sudafed, and Mucinex.
The proposal targets only the oral form of phenylephrine, not the nasal spray version, which remains effective.
A public comment period will last until May 7, 2025, after which the FDA will make a final decision.
The Consumer Healthcare Products Association has expressed disappointment, emphasizing the need for consumer choice in over-the-counter medications.