Overview
- Kenvue said the FDA approved the product on Friday, July 24, 2026, as a single-dose tablet intended to provide up to 12 hours of pain relief by combining acetaminophen with naproxen.
- Company materials and two news outlets report the approved dose as 650 mg acetaminophen plus 220 mg naproxen sodium per dose, but one report listed lower per-pill amounts, creating a public discrepancy that requires checking the official FDA label.
- The FDA cleared the pill for adults and children 12 and older to treat headaches, back pain, muscle aches, toothache, menstrual cramps and minor arthritis pain.
- Kenvue says eight clinical studies show superior pain relief for the fixed-dose combination versus each ingredient alone, and the company reported the FDA granted three years of exclusivity for the formulation, which would delay direct rivals if confirmed in agency records.
- The approval arrives as the Tylenol brand faces revived litigation and state action over alleged risks of acetaminophen use during pregnancy and as Kenvue moves forward with a planned acquisition by Kimberly-Clark that could shape the product's retail rollout.