TYLENOL® with Naproxen, a first-of-its-kind, non-opioid OTC option for the millions managing persistent pain, is backed by more than a decade of research, including Phase 3 data to be presented at PAINWeek
- In two rigorous Phase 3 clinical studies, findings demonstrated the effectiveness of TYLENOL® with Naproxen in both post-surgical dental pain and bunionectomy pain, which raises the bar on clinically proven effectiveness for OTC combination products.
- PAINWeek will also showcase Phase 2 proof-of-concept findings, demonstrating that TYLENOL® with Naproxen has superior efficacy to a prescription hydrocodone (opioid) combination.
- Study results support the recent FDA approval of the first and only over-the-counter (OTC) combination of acetaminophen (650 mg) and naproxen sodium (220 mg) in a single product, filling a longstanding need for a simple option that quickly delivers potent, long-lasting pain relief.
SUMMIT, N.J., Sept. 8, 2026 /PRNewswire/ -- TYLENOL®, the #1 doctor-recommended pain relief brand, will present compelling research data supporting the clinical efficacy of TYLENOL® with Naproxen at the 20th Annual PAINWeek Conference in Las Vegas, September 8-11, 2026. The findings, drawn from two pivotal Phase 3 studies in post-surgical dental pain and bunionectomy pain, reflect more than a decade of rigorous clinical development behind TYLENOL® with Naproxen, a new, non-opioid, OTC combination pain relief medicine approved by the U.S. Food and Drug Administration (FDA) in July 2026.
TYLENOL® with Naproxen combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg of naproxen sodium (a non-steroidal anti-inflammatory drug) in a single dose that begins working in under 30 minutes and provides relief for 12 hours.
"For millions of people managing persistent pain, treatment often means choosing between short-term relief and more complex pain management options. As healthcare professionals and consumers continue to seek effective non-opioid alternatives to treat pain, TYLENOL® with Naproxen offers an evidence-backed option that combines two trusted ingredients in a single fast-acting, potent product, providing a simple approach for clinicians to recommend and patients to use," said Dr. Rajesh Mishra, MD, PhD, Chief Medical Officer, Kenvue.
Phase 3 Studies Demonstrate Superior Performance Across Two Rigorous Pain Clinical Models
The new data evaluated TYLENOL® with Naproxen in two rigorously studied models that have been shown to reflect the type of pain experienced in many common, real-world acute pain conditions.
In a Phase 3 placebo-controlled, randomized, double-blind, factorial clinical study in patients with moderate-to-severe post-operative dental pain, the fixed-dose combination outperformed both acetaminophen alone and naproxen sodium alone (Aleve1 220 mg) over a 12-hour period.2 It also delivered meaningful pain relief faster than naproxen sodium and lasted longer than acetaminophen.2
Separately, in a Phase 3 multiple-dose, placebo-controlled, randomized, double-blind clinical study in post-surgical bunionectomy pain, TYLENOL® with Naproxen delivered significant and sustained pain relief as compared to placebo.3 This is the first clinical study of an OTC-intended pain medicine in the bunionectomy model, a rigorous benchmark often used to evaluate prescription pain therapies. In this study, TYLENOL® with Naproxen reduced the total amount of opioid rescue medication used over 48 hours by nearly 40%, compared with placebo.3 Together, these studies demonstrate consistent effectiveness across distinct pain settings, from dental pain to post-surgical bunionectomy pain. These findings build on earlier research from a previously reported Phase 2 clinical study in post-operative dental pain, in which TYLENOL® dosed alongside naproxen sodium provided more effective and longer-lasting pain relief than a hydrocodone and acetaminophen combination.4
"Across these clinical studies, the fixed-dose combination consistently provided 12 hours of potent pain relief, in two distinct and well-validated pain models. Evaluating an over-the-counter option in post-surgical settings sets a high evidentiary bar for analgesic effectiveness, and these results give clinicians and patients meaningful data to inform pain management decisions," 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.
The PAINWeek presentations share the pivotal data from a clinical program composed of eight studies spanning more than a decade, making TYLENOL® with Naproxen one of the most extensively studied OTC pain innovations introduced in the past decade. Additional analyses and results from the clinical program will be presented at additional upcoming medical meetings in 2026.
TYLENOL® with Naproxen will be coming soon to major U.S. retailers nationwide. To learn more, visit www.tylenol.com or follow TYLENOL® on Instagram and TikTok.
About TYLENOL® with Naproxen and PAINWeek
How many studies and posters are being presented at PAINWeek?
TYLENOL® with Naproxen is featured across four scientific posters – the data from the pivotal Phase 3 dental pain trial will be presented for the first time and compared to the previous Phase 2 proof-of-concept dental pain trial. Data from a second pivotal Phase 3 bunionectomy trial will also be presented for the first time. In addition, there will be posters on the pharmacokinetic/mechanistic rationale and a national pharmacist practice survey – as well as a breakfast symposium, expert roundtable and interactive booth.
Is this the evidence that supported the July 2026 approval?
Yes, the evidence being presented at PAINWeek is part of the 8 clinical studies that supported the FDA approval for TYLENOL® with Naproxen. Additional analyses and study results will be presented at other medical meetings later this year.
Which pain types were evaluated in these studies?
Post-operative dental pain and post-surgical pain after a bunionectomy were evaluated in these studies.
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 single fixed-dose. It is indicated for the temporary relief of minor aches and pain in adults and children 12 years and over and is available without a prescription. For children under 12, consult a healthcare provider.
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. By combining two well-established pain medicines that work through different mechanisms, TYLENOL® with Naproxen was designed to provide powerful pain relief while using lower doses of each ingredient.
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. To learn more, visit www.tylenol.com or follow TYLENOL® on Instagram and TikTok.
How can consumers determine if TYLENOL® with Naproxen is right for them?
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.
Media Contact: Sam Higgins ([email protected])
1 Aleve is a trademark of Bayer Healthcare LLC
2 Budnitz D, et al.
