[9/14/2023] FDA held a Non-prescription Drug Advisory Committee meeting Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter (OTC) cough and cold products that are indicated for the temporary relief of congestion, both as a single ingredient product and in combination with other ingredients.
The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, neither FDA nor the committee raised concerns about safety issues with use of oral phenylephrine at the recommended dose.
Advisory committees provide independent advice and recommendations to FDA, but the agency makes the final decision. FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine.
