FDA Approves First Over-the-Counter Combination Pill of Tylenol and Naproxen for Pain Relief

On July 24, 2026, the FDA approved Tylenol with Naproxen, the first over-the-counter fixed-dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg) per dose. Designed for individuals aged 12 and older, the dual-mechanism pill targets a persistent pain treatment gap, as a March 2026 survey found 75% of sufferers dissatisfied with current options. Backed by eight clinical trials showing superior efficacy to single-agent therapies, the drug provides 12 hours of opioid-free relief.

FDA OTC combination approval

• ▪The U.S. Food and Drug Administration granted Kenvue Inc. a three-year period of marketing exclusivity for the new over-the-counter formulation.
• ▪The U.S. Food and Drug Administration approved Tylenol with Naproxen on July 24, 2026, as the first over-the-counter fixed-dose combination of acetaminophen and naproxen sodium.
• ▪A single dose of Tylenol with Naproxen consists of two tablets, delivering a total of 650 mg of acetaminophen and 220 mg of naproxen sodium.
• ▪Tylenol with Naproxen is approved for adults and children aged 12 years and older to provide temporary relief of minor aches and pains for up to 12 hours.

Persistent pain treatment gap

• ▪A Kenvue Pain Consumer Survey from March 2026 indicated that 75% of persistent pain sufferers reported dissatisfaction with their current pain relief options.
• ▪Tylenol with Naproxen aims to simplify pain management by eliminating the need for patients to coordinate or time multiple separate over-the-counter pain relievers.

Clinical efficacy data

• ▪The approval of Tylenol with Naproxen was supported by eight clinical studies demonstrating superior pain relief compared to acetaminophen alone or naproxen sodium alone.
• ▪Clinical data showed that Tylenol with Naproxen begins providing pain relief in less than 30 minutes and maintains relief for up to 12 hours.

Non-opioid pain management expansion

• ▪Tylenol with Naproxen combines fast-acting acetaminophen, which reduces pain signals, with naproxen sodium, an anti-inflammatory drug that targets pain caused by inflammation.
• ▪The fixed-dose combination provides an opioid-free over-the-counter alternative to help expand non-opioid pain management options for patients and healthcare providers.

Tylenol brand innovation history

• ▪Tylenol brand historical milestones include introducing the first children's liquid acetaminophen product and establishing 500 mg Extra Strength Tylenol as a category standard.
• ▪Kenvue Inc. has a history of pain relief innovation spanning more than 70 years of leadership in acetaminophen science, safety, and stewardship.