FDA approves Tylenol with Naproxen as first OTC combo pain reliever

Kenvue (NYSE: KVUE) announced that the U.S. Food and Drug Administration has approved Tylenol with Naproxen, described as the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium.

The product combines 650 mg of acetaminophen with 220 mg of naproxen sodium in a single dose. According to Kenvue, clinical data from eight studies showed the combination begins working in under 30 minutes and provides pain relief for 12 hours. The studies also showed the combination outperformed either ingredient taken alone.

The FDA granted Tylenol a three-year exclusivity period for the new OTC formulation.

"Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options," said Dr. Rajesh Mishra, Chief Medical Officer at Kenvue. "Tylenol with Naproxen simplifies that choice, offering fast onset, 12-hour duration, and the safety profile of two well-established non-opioid ingredients in one fixed-dose."

Clinical data supporting the product's efficacy is expected to be presented at PAINWeek 2026. Tylenol with Naproxen is set to become available at major U.S. retailers nationwide, with no prescription required.

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