TYLENOL recently announced that the US Food and Drug Administration (FDA) has approved TYLENOL with Naproxen—the first and only Over?the?Counter (OTC) fixed?dose combination of acetaminophen and naproxen sodium—redefining what's possible in non-prescription pain management.

TYLENOL with Naproxen combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg naproxen sodium (a non-steroidal anti-inflammatory drug) in one dose, which begins working in under 30 minutes and provides relief for 12 hours.

According to the Kenvue Pain Consumer Survey (March 2026, n=6,240), an estimated 75 percent of persistent pain sufferers report dissatisfaction with their current relief options, and the US Department of Labor reports that up to 1 in 4 patients prescribed opioids are at risk of addiction.

TYLENOL with Naproxen addresses this gap by combining 2 well-established non-opioid pain relievers into a single, clinically proven OTC therapeutic solution that requires no prescription and carries no opioid risk. For many patients, managing persistent pain has meant navigating a complex, multi-step approach involving multiple medications, staggered dosing schedules, or prescription options. It helps simplify pain management with a multimodal OTC option designed to support both adherence and relief.

The FDA has granted TYLENOL a 3-year period of exclusivity for this new OTC formulation, underscoring the significance of this innovation in serving those suffering from pain.