FDA-approved first and only OTC fixed\u2011dose combination of acetaminophen and naproxen sodium, expanding non-opioid options for persistent pain.Addresses a critical gap in persistent pain relief \u2013 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\u00ae leadership in pain relief innovation, advancing a more streamlined, multimodal approach for patients and healthcare providers.<\/p>\n
SUMMIT, N.J., July 24, 2026 \u2014 Tylenol\u00ae, the #1 doctor\u2011recommended pain relief brand, today announced that the U.S. Food and Drug Administration (FDA) has approved Tylenol\u00ae with Naproxen\u2014the first and only over\u2011the\u2011counter (OTC) fixed\u2011dose combination of acetaminophen and naproxen sodium \u2014 redefining what\u2019s possible in non-prescription pain management. Tylenol\u00ae 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.<\/p>\n
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\u00ae 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\u00ae with Naproxen helps simplify pain management with a multimodal OTC option designed to support both adherence and relief.<\/p>\n
The FDA has granted Tylenol\u00ae a three-year period of exclusivity for this new OTC formulation, underscoring the significance of this innovation in serving those suffering from pain.<\/p>\n
Delivering Innovation Backed by Decades of Pain Relief Leadership<\/p>\n
Building on more than 70 years of leadership in acetaminophen science, safety and stewardship, Tylenol\u00ae with Naproxen expands the brand\u2019s long history of category-defining innovation. Milestones include introducing the first children\u2019s 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\u00ae.<\/p>\n
\u201cThis milestone reflects the long-standing leadership of Tylenol\u00ae in translating rigorous clinical science into accessible, over\u2011the\u2011counter solutions,\u201d said Dr. Rajesh Mishra, MD, PhD; Chief Medical Officer, Kenvue. \u201cPersistent pain often leaves people trapped in a cycle of trial and error, navigating between choosing short-term relief or more complex treatment options. Tylenol\u00ae 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.\u201d<\/p>\n
Robust Clinical Evidence Supporting Efficacy and Use<\/p>\n
Across eight clinical studies, Tylenol\u00ae with Naproxen demonstrated:<\/p>\n
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.<\/p>\n
Clinical data demonstrating the efficacy and use of Tylenol\u00ae with Naproxen across multiple pain models will be presented at upcoming medical congresses, including PAINWeek 2026.<\/p>\n
\u201cThe clinical program behind Tylenol\u00ae 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\u2019s the rigor of the development program and the fact that patients can now access a clinically proven fixed-dose combination over-the-counter,\u201d said Todd Bertoch, MD, Chief Medical Officer, Pain Research at CenExel Clinical Research, Inc., and a principal investigator on the Tylenol\u00ae with Naproxen clinical program.<\/p>\n
Tylenol\u00ae with Naproxen will be coming soon to major U.S. retailers nationwide. To learn more, visit www.tylenol.com\/tylenol-with-naproxen<\/a> or follow Tylenol\u00ae on Instagram and TikTok.<\/p>\n About Tylenol\u00ae with Naproxen<\/p>\n What is Tylenol\u00ae with Naproxen? How is it different from regular Tylenol\u00ae or Aleve? How does Tylenol\u00ae with Naproxen work? Is Tylenol\u00ae with Naproxen an opioid? When and where will Tylenol\u00ae with Naproxen be available? Who should not take Tylenol\u00ae with Naproxen? About Tylenol\u00ae Cautions Concerning Forward-Looking Statements A list and descriptions of risks, uncertainties and other factors can be found in Kenvue\u2019s 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<\/a> 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.<\/p>\n [1] Aleve is a trademark of Bayer Healthcare LLC<\/p>\n","protected":false},"excerpt":{"rendered":"FDA-approved first and only OTC fixed\u2011dose combination of acetaminophen and naproxen sodium, expanding non-opioid options for persistent pain.Addresses…\n","protected":false},"author":2,"featured_media":783802,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[58],"tags":[97,243],"class_list":["post-783801","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/783801","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=783801"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/783801\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/783802"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=783801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=783801"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=783801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Tylenol\u00ae 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. <\/p>\n
Single-ingredient Tylenol\u00ae\u202fcontains\u202facetaminophen only. Aleve\u202fcontains\u202fnaproxen sodium only. Tylenol\u00ae with\u202fNaproxen combines\u202fthe\u202ffast-acting relief\u202fof acetaminophen with the\u202flong-lasting\u202fpower of a\u202fnon-steroidal\u202fanti-inflammatory drug,\u202fnaproxen\u202fsodium\u202f\u2013 starting to work\u202fin under 30 minutes\u202fand delivering\u202feffective\u202fpain relief\u202ffor 12 hours.\u202f <\/p>\n
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. <\/p>\n
No. Tylenol\u00ae with Naproxen is opioid-free. It is intended to expand non-opioid pain management options for patients and healthcare providers. <\/p>\n
Tylenol\u00ae 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. <\/p>\n
Consumers should always read and follow the Drug Facts label and talk with a healthcare professional if they have questions about whether Tylenol\u00ae with Naproxen is right for them.\u202f <\/p>\n
Tylenol\u00ae \u2013 the #1 doctor-recommended brand of pain and fever relief \u2013 offers a growing portfolio of products designed to help people manage their health. From trusted OTC medicines to innovative topicals, Tylenol\u00ae is committed to providing Care Without Limits\u2122 by addressing a wide range of needs across ages and through every stage of life. Tylenol\u00ae is a brand of Kenvue Brands LLC, a subsidiary of Kenvue Inc.<\/p>\n
This press release contains \u201cforward-looking statements\u201d as defined in the Private Securities Litigation Reform Act of 1995 regarding the development of Tylenol\u00ae with Naproxen. Forward-looking statements may be identified by the use of words such as \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates\u201d 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.<\/p>\n