The U.S. Food and Drug Administration has approved an over-the-counter pill that combines two pain relievers into a single tablet.
In a news release, the FDA said it gave the OK for a non-prescription combination dosage of 650 milligrams of Tylenol (acetaminophen) and 220 milligrams of naproxen sodium, the generic name for Aleve.
The federal agency said that the tablet can be used by adults and children 12 and older for temporary relief of headaches, back pain, muscle aches, toothaches, menstrual cramps and minor pain from arthritis.
The FDA granted Tylenol with a three-year period of exclusivity for the new over-the-counter formulation.
FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg) — the first fixed-dose combination of these two well-known pain relievers in a single tablet. pic.twitter.com/7BT3HKtEKT
— FDA Drug Information (@FDA_Drug_Info) July 24, 2026
According to Tylenol’s website, the combination of the two pain relievers begins to take effect in less than 30 minutes and keeps pain controlled for 12 hours.
Kenvue, which owns Tylenol, said the combination of the pain relievers will soon be available for purchase without a prescription at major retailers, USA Today reported.
Tylenol quickly reduces pain signals while naproxen sodium targets inflammation, Michelle Bateson, who oversees North America research and development at Kenvue, told the newspaper.
The combination was evaluated across eight clinical studies and demonstrated “superior pain relief” compared to the individual medications, Bateson added.
The FDA granted Tylenol a three-year period of exclusivity for the over-the-counter combination.
“This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over‑the‑counter solutions,” Rajesh Mishra, chief medical officer at Kenvue, said in a statement. “Persistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options.
“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.”
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