SUMMIT, N.J. – TYLENOL on Friday announced that the U.S. Food and Drug Administration (FDA) has approved TYLENOL with Naproxen, the first and only over-the-counter fixed-dose combination of acetaminophen and naproxen sodium. The product combines 650 mg of acetaminophen with 220 mg of naproxen sodium, delivering fast-acting pain relief in as little as 30 minutes and lasting up to 12 hours. The approval marks a new option in nonprescription pain management by pairing the rapid onset of acetaminophen with the long-lasting pain-relieving and anti-inflammatory benefits of naproxen sodium.
According to the Kenvue Pain Consumer Survey (March 2026, n=6,240), an estimated 75% of persistent pain sufferers report dissatisfaction with their current relief options, and the U.S. 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 two 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. TYLENOL with Naproxen helps simplify pain management with a multimodal OTC option designed to support both adherence and relief.
The FDA has granted TYLENOL a three-year period of exclusivity for this new OTC formulation, underscoring the significance of this innovation in serving those suffering from pain.
Delivering Innovation Backed by Decades of Pain Relief Leadership
Building on more than 70 years of leadership in acetaminophen science, safety and stewardship, TYLENOL with Naproxen expands the brand's long history of category-defining innovation. Milestones include introducing the first children's liquid acetaminophen product, and for adults, helping to establish higher-dose OTC pain relief as a new category standard with the launch of 500 mg Extra Strength TYLENOL.
"This milestone reflects the long-standing leadership of TYLENOL in translating rigorous clinical science into accessible, over‑the‑counter solutions," said Dr. Dr. Rajesh Mishra, Chief Medical Officer, 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."
Robust Clinical Evidence Supporting Efficacy and Use
Across eight clinical studies, TYLENOL with Naproxen demonstrated:
- Superior pain relief versus acetaminophen alone and naproxen sodium (Aleve 220mg) alone.
- Onset of relief in under 30 minutes.
- Duration of relief for 12 hours in a single dose.
Clinical data demonstrating the efficacy and use of TYLENOL with Naproxen across multiple pain models will be presented at upcoming medical congresses, including PAINWeek 2026.
"The clinical program behind TYLENOL with Naproxen was designed to answer a practical question: could we deliver fast onset and sustained pain relief in a single, opioid-free OTC option, without asking patients to combine multiple products on their own? Across the eight clinical studies supporting the FDA approval, the 650 mg acetaminophen and 220 mg naproxen sodium fixed-dose combination consistently outperformed either ingredient alone. What makes this meaningful for clinicians is not just the efficacy; it's the rigor of the development program and the fact that patients can now access a clinically proven fixed-dose combination over-the-counter," said Dr. Todd Bertoch, Chief Medical Officer, Pain Research at CenExel Clinical Research, Inc., and a principal investigator on the TYLENOLwith Naproxen clinical program.
TYLENOL with Naproxen will be coming soon to major U.S. retailers nationwide. To learn more, visit www.tylenol.com/tylenol-with-naproxen or follow TYLENOL on Instagram and TikTok.
