The U.S. Food and Drug Administration has approved Tylenol with Naproxen, marking the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium. The non-prescription medication combines 650 mg of acetaminophen with 220 mg of naproxen sodium in a single dose.
The formulation is designed to provide non-opioid pain relief that begins working in under 30 minutes and lasts for up to 12 hours. The fixed-dose approach eliminates the need for consumers to combine or time separate over-the-counter pain relievers on their own.
Approval was supported by data from eight clinical studies evaluating the combination’s efficacy across various pain models. Results from the trial program showed superior pain reduction compared to standalone doses of acetaminophen or naproxen sodium.
The FDA granted developer Kenvue a three-year period of exclusivity for the new over-the-counter formulation. Additional clinical data regarding the product’s performance will be presented at upcoming industry events, including PAINWeek 2026.
Tylenol with Naproxen will be distributed nationwide through major U.S. retail locations. Detailed product labeling and usage guidance will be provided on product packaging as retail distribution begins.
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