FDA Approves TYLENOL® with Naproxen, the First and Only Over-the-Counter Fixed-Dose Combination of Acetaminophen (650 mg) and Naproxen Sodium (220 mg)

TYLENOL® with Naproxen is a clinically proven, opioid-free, fixed-dose combination that begins working in under 30 minutes and provides 12 hours of pain relief in a single dose.

• FDA-approved first and only OTC fixed‑dose combination of acetaminophen and naproxen sodium, expanding non-opioid options for persistent pain.
• Addresses a critical gap in persistent pain relief – 75% of persistent pain sufferers report dissatisfaction with current options (Kenvue Pain Consumer Survey, March 2026, n=6,240).
• Simplifies pain management with a single, clinically proven fixed-dose combination, eliminating the need to time or coordinate multiple over-the-counter pain relievers.
• Backed by eight clinical studies demonstrating superior pain relief versus acetaminophen alone and naproxen sodium alone (Aleve¹ 220 mg).
• Builds on more than 70 years of TYLENOL® leadership in pain relief innovation, advancing a more streamlined, multimodal approach for patients and healthcare providers.

SUMMIT, N.J., July 24, 2026 /PRNewswire/ -- TYLENOL®, the #1 doctor‑recommended pain relief brand, today announced that the U.S. 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% 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. Rajesh Mishra, MD, PhD; 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 Todd Bertoch, MD, Chief Medical Officer, Pain Research at CenExel Clinical Research, Inc., and a principal investigator on the TYLENOL® with 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.

About TYLENOL® with Naproxen

What is TYLENOL® with Naproxen?
TYLENOL® with Naproxen is the first and only FDA-approved over-the-counter pain reliever that combines 650 mg of acetaminophen and 220 mg of naproxen sodium in a fixed-dose. It is indicated for the temporary relief of pain and is available without a prescription. 

How is it different from regular TYLENOL® or Aleve?
Single-ingredient TYLENOL® contains acetaminophen only. Aleve contains naproxen sodium only. TYLENOL® with Naproxen combines the fast-acting relief of acetaminophen with the long-lasting power of a non-steroidal anti-inflammatory drug, naproxen sodium – starting to work in under 30 minutes and delivering effective pain relief for 12 hours.

How does TYLENOL® with Naproxen work?
Acetaminophen is believed to work quickly to reduce pain signals. Naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), provides longer-lasting relief by targeting pain caused by inflammation. Combining them in a single dose delivers both fast onset and extended duration of pain relief. 

Is TYLENOL® with Naproxen an opioid?
No. TYLENOL® with Naproxen is opioid-free. It is intended to expand non-opioid pain management options for patients and healthcare providers.

When and where will TYLENOL® with Naproxen be available?
TYLENOL® with Naproxen will be coming soon to major U.S. retailers nationwide. The FDA has granted Kenvue a three-year period of exclusivity for this new OTC formulation.

Who should not take TYLENOL® with Naproxen?
Consumers should always read and follow the Drug Facts label and talk with a healthcare professional if they have questions about whether TYLENOL® with Naproxen is right for them.

About TYLENOL® 
TYLENOL® – the #1 doctor-recommended brand of pain and fever relief – offers a growing portfolio of products designed to help people manage their health. From trusted OTC medicines to innovative topicals, TYLENOL® is committed to providing Care Without Limits™ by addressing a wide range of needs across ages and through every stage of life. TYLENOL® is a brand of Kenvue Brands LLC, a subsidiary of Kenvue Inc.

Cautions Concerning Forward-Looking Statements 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the development of TYLENOL^® with Naproxen. Forward-looking statements may be identified by the use of words such as "plans," "expects," "will," "anticipates," "estimates" and other words of similar meaning. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Inc. and its affiliates.

A list and descriptions of risks, uncertainties and other factors can be found in Kenvue's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent Quarterly Reports on Form 10-Q and other filings, available at www.kenvue.com or on request from Kenvue. Kenvue and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise.

¹ Aleve is a trademark of Bayer Healthcare LLC

Media Contact: Sam Higgins ([email protected])

SOURCE Kenvue Inc.