Does This Popular Decongestant Work? The FDA Says No

The FDA recently called to phase out phenylephrine, a common nasal decongestant found in hundreds of over-the-counter medications including DayQuil, Sudafed, Dimetapp, and Benadryl. U.S. officials have long questioned the effectiveness of oral phenylephrine claiming that it does not successfully relieve nasal congestion and should be removed or reformulated by drug manufacturers.

The FDA’s move comes after federal advisers voted unanimously in 2023 that there was no evidence to support that phenylephrine relieves congestion in oral medications. The reasoning is that oral medications that include phenylephrine are no longer effective once they hit the stomach. Acids in the gut deactivate the decongestant making it ineffective once it reaches the bloodstream and the nose. Researchers from the University of Florida have been ringing alarm bells since 2007 when they first petitioned the FDA to review the drug’s use and effectiveness. Experts reviewed studies dating back to the 1970s that supported the drug’s initial use and found many flaws and questionable data.

Phenylephrine hasn’t always been used in cold and allergy products. Most were originally formulated with a different decongestant, pseudoephedrine, however a 2006 law required drugs that included pseudoephedrine be moved behind pharmacy counters as they gained popularity in the illegal manufacturing and use of methamphetamine.

Pseudoephedrine is used in Claritin D, Sudafed, and many other products as an effective relief for congestion, it just requires valid ID to purchase. Other over-the-counter alternatives include saline rinses that are a safe and fast way to clear mucus and relieve congestion, as well as more long-term and the most effective medications for seasonal congestion, itching and sneezing like Flonase and Nasacort.

Medications containing phenylephrine will be on the shelves and available until government regulators complete the lengthy process to remove an ingredient from the FDA’s approved list of drugs. While it can be difficult to prevent the common cold, remember to wash your hands regularly, clean and sanitize surfaces, avoid close contact with those who are sick and prioritize regular exercise and sleep to stay healthy.