FDA Proposes Removal of Common Oral Cold Medication Ingredient as ‘Ineffective’

The agency said phenylephrine is ineffective for nasal congestion relief when used orally, and proposed its removal from over-the-counter oral cold medicines.

Non-prescription drugs are displayed on a shelf at a pharmacy in New York City. Spencer Platt/Getty Images)

The U.S. Food and Drug Administration (FDA) announced on Nov. 7 that it is proposing to remove oral phenylephrine, a widely used active ingredient in over-the-counter (OTC) cold medications, from the market.

After an extensive review of scientific data, the FDA concluded that oral phenylephrine is ineffective for relieving nasal congestion.