The U.S. FDA has approved Tylenol with Naproxen — the first and only over‑the‑counter, fixed‑dose combination of acetaminophen and naproxen sodium.
The new approval combines two well-established non-opioid pain relievers into a single, clinically proven OTC therapeutic solution that requires no prescription and carries no opioid risk. The drug, which will be made by Kenvue, combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg naproxen sodium in one dose, which begins working in under 30 minutes and provides relief for 12 hours.
Clinical data demonstrating the efficacy and use of Tylenol with Naproxen across multiple pain models will be presented at upcoming medical congresses, including PAINWeek 2026.
The FDA has granted Tylenol a three-year period of exclusivity for the new OTC formulation.