FDA Approves First OTC Combination of Acetaminophen and Naproxen for 12-Hour Pain Relief

The FDA approved Tylenol with Naproxen on July 24, 2026, making it the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium cleared for sale in the United States.

Each tablet contains 650 mg of acetaminophen and 220 mg of naproxen sodium. The product is approved for adults and children 12 and older for temporary relief of minor aches and pains, including headaches, backaches, muscular aches, toothaches, menstrual cramps, and minor arthritis.

Manufacturer Kenvue Brands LLC says the combination begins working in under 30 minutes and provides up to 12 hours of relief per dose. The company backed the approval with eight clinical studies showing the combination outperforms either ingredient used alone.

The FDA granted Kenvue a three-year period of market exclusivity for the formulation.

The approval is tied to "The Great Healthcare Plan," a federal initiative aimed at expanding safe over-the-counter pharmaceutical options to lower healthcare costs.

Doctors caution users not to take the product alongside other medications containing acetaminophen, to avoid liver damage risk. Because it contains naproxen sodium, the label also warns of increased risks of stomach bleeding, heart attack, heart failure, and stroke if used longer or in higher doses than directed.

Pregnant individuals are advised to consult a healthcare professional before use, with a specific warning against naproxen sodium at or after 20 weeks of pregnancy.

Clinical findings from the program are scheduled for presentation at PAINWeek 2026 in Las Vegas.