Sarah Cava, PharmD, Allina Health
On November 7th, 2024, the FDA announced its proposal to remove oral phenylephrine as an active ingredient listed in over the counter (OTC) drug product monographs for nasal decongestion due to a lack of evidence of efficacy. Safety of phenylephrine was considered in the review, but did not contribute to the resulting recommendation. The proposal came after reviewing historical data, updated clinical data, and hosting a Nonprescription Drug Advisory Committee to discuss the ‘Generally Recognized as Safe and Effective (GRASE) status of the drug.
Phenylephrine is currently marketed as an effective nasal decongestant in many OTC cold and cough and allergy drug products, either as a single active ingredient or in combination with other active ingredients. While its inclusion in combination medications does not impact the effectiveness of other ingredients, it does not produce the congestion-relieving effect that patients may be seeking when reading drug information labels. Commonly used OTC products that list phenylephrine as an “active” ingredient are Dayquil/Nyquil®, Benadryl Allergy Plus®, Sudafed PE®, and Mucinex Fast-Max® .
This proposal does not mean the immediate removal of the GRASE status of phenylephrine, and companies may continue to market these products. The public is invited to provide input on the proposed order by following the instructions available on the OTC Monographs page of the FDA’s website. Once comments are considered, if phenylephrine is still concluded to not be effective, a final order will be released and the FDA will provide manufacturers with a timeline to either reformulate or remove their products containing phenylephrine.
Published March 7, 2025
Reference:
- FDA proposes ending use of oral phenylephrine as OTC monograph nasal decongestant active ingredient after extensive review. U.S. Food and Drug Administration. Published November 7, 2024. Accessed December 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-proposes-ending-use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient-after