> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Panel to Weigh OTC Phenylephrine Efficacy
- URL: https://www.fdaweb.com/panel-to-weigh-otc-phenylephrine-efficacy/
- Published: 2023-03-06T12:00:00.000Z
- Updated: 2026-09-14T18:18:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153913

FDA has announced a 4/12 Nonprescription Drugs Advisory Committee meeting to discuss the adequacy of efficacy data available for over-the-counter (OTC) use of oral phenylephrine as a nasal decongestant. Panel members are also scheduled to discuss whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not “Generally Recognized as Safe and Effective” due to lack of efficacy, according to an [agency notice](https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-12-2023-meeting-nonprescription-drugs-advisory-committee-meeting-announcement-04122023?ref=fdaweb.com#event-information).

There has reportedly been growing evidence to question the effectiveness of the OTC phenylephrine-containing products. A 2015 [citizen petition](https://www.regulations.gov/document/FDA-2015-P-4131-0001?ref=fdaweb.com) urged FDA to issue a final rule removing oral phenylephrine from the OTC Nasal Decongestant Drug Products final monograph and to remove phenylephrine bitartrate from a 2006 amendment to the monograph because the ingredients are not effective. The petition, which was submitted by two University of Florida professors, cites four studies that demonstrate that phenylephrine “is no more effective than placebo in decreasing nasal congestion and increasing the dose fourfold did not provide additional benefit.”