The US Food and Drug Administration (FDA) has released an update proposing the removal of oral phenylephrine hydrochloride and oral phenylephrine bitartrate as the active ingredients in over-the-counter (OTC) drugs for treating nasal congestion. New findings reveal that oral phenylephrine is less effective compared to other ingredients. This report only applies to oral forms such as pills or liquids and not sprays.
Oral phenylephrine is commonly used in many OTC brands such as Benadryl, Advil and Tyleno, as well as other cold, cough, allergy, bronchodilator and anti-asthmatic drug products.
A study by The National Institutes of Health in 2023 revealed that oral phenylephrine was not more effective than the placebo at doses of 10 to 40 mg every four hours. The FDA has since conducted a review based on data from the past 30 years, revealing that phenylephrine does not provide adequate relief when administered orally. This has resulted in the FDA’s proposed order.
The FDA said: ‘The proposed order is based on effectiveness concerns, not on safety concerns.’ Drug products that contain oral phenylephrine can still be marketed until the agency issues a final order.
The FDA is seeking comments, experience or evidence from patients and professionals, which should be submitted to the OTC Monographs@FDA portal by 7 May 2025. It will review the comments to conclude if oral phenylephrine is effective as a nasal decongestant and, if it is found to be not effective, will issue a final order to manufacturers to remove it from the OTC monograph, meaning that drugs containing the ingredient would either need to be reformulated or removed from the market.
The FDA’s Proposed Administrative Order contains further reading and instructions for submitting comments.
