FDA approves first-of-its-kind pain medication for long-lasting relief
Kenvue's Tylenol with Naproxen just became the first FDA-approved pill combining acetaminophen and naproxen sodium — two pain relievers people already take together, now in one 12-hour dose.
Chloe Mitchell 
Pain relief is getting a major upgrade. The Food and Drug Administration officially approved a groundbreaking over-the-counter medication on July 24 that combines Tylenol and naproxen sodium into a single, power-packed pill.
A New Standard for 12-Hour Relief
According to the FDA, the new product, branded as Tylenol with Naproxen, is available for adults and children 12 and older. It is specifically designed to tackle minor aches and pains, such as backaches, muscle soreness, and headaches, offering up to 12 hours of relief in one dose.
Inside the Formulation
Each dose consists of two tablets, providing a total of 650 mg of acetaminophen and 220 mg of naproxen sodium. While other over-the-counter drugs have paired acetaminophen with different NSAIDs in the past, this marks the first time naproxen sodium has been combined with acetaminophen in this manner.
According to an announcement from Kenvue on July 24, the medication begins working in under 30 minutes, merging the fast-acting nature of acetaminophen with the long-lasting anti-inflammatory power of naproxen.
Addressing Patient Dissatisfaction
Kenvue, the Summit, New Jersey-based company behind the innovation, developed this solution after identifying a significant gap in the market. A March 2026 survey of 6,240 people revealed that 75% of those dealing with persistent pain were not satisfied with their current options.
By creating a clinically proven, non-opioid therapeutic solution that requires no prescription, Kenvue aims to provide a more effective alternative for chronic sufferers. The FDA has granted a three-year period of exclusivity for this new formulation, highlighting its importance in the landscape of consumer health.
