FDA Will Finally Ban Controversial Ingredient in Popular Decongestants

March 01, 2025 | Source: Science Alert | by Carly Cassella

Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks, and Dimetapp.

These popular brand names appear on oral decongestants that are staples of the cold and flu aisle in American drug stores, and yet many contain an ingredient that does not work as promised.

In November 2024, the US Food and Drug Administration (FDA) proposed an order to remove oral phenylephrine from every single cold, cough, allergy, bronchodilator, and anti-asthmatic drug product available today, roughly four-fifths of all oral decongestants.

The proposal is currently open for public comment, and, if finalized, the ruling would dramatically reshape the drug formulations seen in hundreds of over-the-counter oral decongestants available for purchase in the country – a market share worth roughly US$1.76 billion in 2022.