The FDA has approved a new over-the-counter pain medication that puts two familiar drugs into a single pill. The product, called Tylenol with Naproxen, combines acetaminophen, the active ingredient in Tylenol, with naproxen sodium, the active ingredient in Aleve. According to Healthline, the drug is expected to be available at retailers across the United States soon.
Kenvue, the company that makes Tylenol, manufactures the new product. Each tablet contains 325 milligrams of acetaminophen and 110 milligrams of naproxen sodium. The recommended dose is two tablets every 12 hours.
Kenvue says the drug starts working within 30 minutes and provides pain relief for up to 12 hours. The company says the combination delivers the fast-acting relief associated with acetaminophen along with the longer-lasting effectiveness of naproxen sodium. Eight clinical studies were cited by Kenvue to support claims that the combination provides superior pain relief compared with either ingredient alone. Those study results have not yet been published in a peer-reviewed journal, but the findings are scheduled to be presented at PainWeek 2026 in Las Vegas in September.
The FDA said the product is intended for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis in adults and children 12 years and older.
Rajesh Mishra, MD, chief medical officer at Kenvue, described the approval as a milestone for accessible pain treatment. "This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over-the-counter solutions," he 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."
The FDA also granted Kenvue a three-year period of exclusivity for the new over-the-counter formulation, meaning competitors cannot immediately copy the product. The agency noted that the approval is part of President Donald Trump's program, The Great Healthcare Plan, which aims to make more verified safe pharmaceutical drugs available for over-the-counter purchase to increase consumer choices and lower medication costs.
Kenvue pointed to its own March 2026 survey, in which 75 percent of people with persistent pain reported dissatisfaction with their current relief options. The company also referenced U.S. Department of Labor data indicating that up to 1 in 4 people prescribed opioids are at risk of addiction. Kenvue positioned the new drug as an answer to both problems, describing it as a non-opioid solution that requires no prescription and carries no opioid risk.
The new combination pill enters a market where non-opioid alternatives have drawn growing interest from both regulators and consumers. With no prescription required and a familiar brand name, the product is positioned to reach a broad segment of the adult pain relief market when it hits shelves.
