The FDA has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter combination of 650-milligram acetaminophen and 220-milligram naproxen sodium.
The product combines acetaminophen and naproxen sodium in a single over-the-counter formulation and was granted three years of exclusivity by the FDA, according to a July 24 press release.
Kenvue said the approval was based on eight clinical studies that found the combination provided greater pain relief than acetaminophen alone or naproxen sodium alone. The company also cited a March 2026 survey of 6,240 people in which 75% of persistent pain sufferers reported dissatisfaction with their current pain relief options.
