The Food and Drug Administration has approved an over-the-counter pain medication that combines the active ingredient in Tylenol with the active ingredient in Aleve.
Tylenol with Naproxen soon will be available on the market. Tylenol parent company Kenvue said the drug combines the fast-acting pain relief of acetaminophen with the longer-lasting effects of naproxen sodium. Kenvue said the drug begins working within 30 minutes and lasts up to 12 hours.
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Kenvue said eight clinical studies showed the new drug provided better pain relief than acetaminophen alone or naproxen sodium alone.
The FDA said the medication can be used for the temporary relief of minor aches and pains caused by headaches, backaches, muscle aches, toothaches, menstrual cramps and minor arthritis pain in adults and children 12 and older.
This milestone reflects the long-standing leadership of Tylenol in translating rigorous clinical science into accessible, over-the-counter solutions, said Dr. Rajesh Mishra, chief medical officer at Kenvue. 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.
The FDA said the approval aligns with the Trump administrations Great Healthcare Plan, which the agency said is intended to expand access to safe over-the-counter medications.
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Kenvue was granted three years of market exclusivity for the drug.