(Ottawa) November 11, 2024 – FHCP and our members have monitored the U.S. Food and Drug Administration’s proposal to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) monograph drug products. This is a proposed order and only a final order will affect what products can be marketed.

It is important to note that the FDA review of available data determined that oral phenylephrine is not effective for temporary relief of nasal congestion. In this proposed order, FDA confirmed that concerns with phenylephrine are based on effectiveness concerns, not on safety concerns.

In Canada, phenylephrine is approved for use as an oral decongestant. FHCP and our members will work with Health Canada to ensure self-care options continue to be readily available for Canadians during the upcoming cold and flu season.