TYLENOL with Naproxen stands as a clinically tested opioid-free fixed-dose product that starts working in under 30 minutes and supplies 12 hours of pain relief from one dose.

FDA-cleared first and only OTC fixed-dose blend of acetaminophen and naproxen sodium that widens non-opioid choices for ongoing pain.
Fills a key need in ongoing pain relief as 75 percent of those with persistent pain express dissatisfaction with present choices (Kenvue Pain Consumer Survey March 2026 n=6240).
Simplifies pain care through one clinically tested fixed-dose product removing the need to schedule or combine separate over-the-counter pain items.
Supported by eight clinical trials showing stronger pain relief than acetaminophen alone or naproxen sodium alone (Aleve 220 mg).
Extends more than 70 years of TYLENOL leadership in pain relief progress by advancing a streamlined multimodal method for patients and healthcare providers.

PRNewswire TYLENOL the top doctor-recommended pain relief brand announced today that the U.S. Food and Drug Administration has cleared TYLENOL with Naproxen the first and only over-the-counter fixed-dose blend of acetaminophen and naproxen sodium that reshapes non-prescription pain care. TYLENOL with Naproxen merges the quick relief of 650 mg acetaminophen with the extended analgesic effect of 220 mg naproxen sodium an NSAID in one dose that starts working in under 30 minutes and lasts 12 hours.

The Kenvue Pain Consumer Survey March 2026 n=6240 shows about 75 percent of those with ongoing pain feel unhappy with current relief choices while the U.S. Department of Labor notes up to one in four patients given opioids face addiction risk. TYLENOL with Naproxen meets this need by joining two established non-opioid pain relievers into one clinically tested OTC solution that needs no prescription and carries no opioid risk. Many patients dealing with ongoing pain have faced a complicated multi-step process with several medicines staggered schedules or prescription choices. TYLENOL with Naproxen eases pain care through a multimodal OTC choice meant to aid adherence and relief.

The FDA granted TYLENOL a three-year exclusivity period for this new OTC formula highlighting the value of this advance for those in pain.

Bringing Innovation Built on Decades of Pain Relief Leadership

Drawing on more than 70 years of acetaminophen science safety and guidance TYLENOL with Naproxen grows the brand long record of category-shaping progress. Key steps include the first children's liquid acetaminophen item and for adults setting higher-dose OTC pain relief as a standard with the launch of 500 mg Extra Strength TYLENOL.

This step shows the lasting leadership of TYLENOL in turning strong clinical science into accessible over-the-counter solutions said Dr. Rajesh Mishra MD PhD Chief Medical Officer Kenvue. Ongoing pain often leaves people stuck in a loop of trial and error moving between short-term relief or more involved treatment paths. TYLENOL with Naproxen eases that path by offering fast start 12-hour length and the safety record of two established non-opioid ingredients in one fixed dose.

Strong Clinical Data Backing Effectiveness and Use

Across eight clinical trials TYLENOL with Naproxen showed superior pain relief versus acetaminophen alone and naproxen sodium Aleve 220 mg alone onset of relief in under 30 minutes and duration of relief for 12 hours in a single dose.

Clinical findings on the effectiveness and use of TYLENOL with Naproxen across several pain models will be shared at upcoming medical meetings including PAINWeek 2026.

The clinical program for TYLENOL with Naproxen aimed to answer a practical question could we provide fast start and sustained pain relief in one opioid-free OTC choice without requiring patients to combine multiple products themselves said Todd Bertoch MD Chief Medical Officer Pain Research at CenExel Clinical Research Inc. and a lead investigator on the TYLENOL with Naproxen clinical program. Across the eight clinical trials backing the FDA clearance the 650 mg acetaminophen and 220 mg naproxen sodium fixed-dose blend consistently outperformed either ingredient alone. What stands out for clinicians is not only the effectiveness but the strength of the development program and the fact that patients can now reach a clinically tested fixed-dose blend over the counter.

TYLENOL with Naproxen will reach major U.S. retailers nationwide soon. To learn more visit the TYLENOL site 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-cleared over-the-counter pain reliever that blends 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 blends 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 reach major U.S. retailers nationwide soon. 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 top 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 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 the Kenvue site 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

SOURCE Kenvue Inc.