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news.The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen (650mg) and naproxen sodium (220mg).
The FDA approval grants Kenvue a three-year exclusivity period for the new OTC formulation. Credit: DC Studio / Shutterstock.com.
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This combination aims to provide an additional non-opioid pain relief option without the need for prescriptions.
The approval introduces a new choice for individuals seeking relief from persistent pain.
Tylenol with Naproxen combines acetaminophen, known for its fast-acting effect, with naproxen sodium, a non-steroidal anti-inflammatory drug, which is intended to offer longer-lasting results.
The combined formulation begins working in under 30 minutes and delivers pain relief for up to 12 hours.
Kenvue cited results from eight clinical studies that evaluated the performance of Tylenol with Naproxen against products containing either acetaminophen or naproxen sodium alone.
The company noted that data showed improved pain relief with the fixed-dose combination compared to the individual ingredients.
The company referenced findings from the Kenvue Pain Consumer Survey conducted in March 2026, which involved 6,240 respondents.
In that survey, approximately 75% of people living with persistent pain reported dissatisfaction with current pain relief methods.
Kenvue chief medical officer Dr Rajesh Mishra said: “This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over-the-counter solutions.
“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.”
FDA approval of Tylenol with Naproxen grants Kenvue a three-year period of exclusivity for the new OTC formulation.
Tylenol with Naproxen is expected to be available soon at major retailers across the US.
