SUMMIT, N.J. – TYLENOL will present new research highlighting the clinical efficacy of TYLENOL with Naproxen at the 20th Annual PAINWeek Conference in Las Vegas, Sept. 8-11, 2026. The data come from two pivotal Phase 3 studies examining post-surgical dental pain and bunionectomy pain and reflect more than a decade of clinical development behind TYLENOL with Naproxen, a new non-opioid over-the-counter pain reliever approved by the U.S. Food and Drug Administration in July 2026.
TYLENOL with Naproxen combines 650 mg of acetaminophen for fast-acting relief with 220 mg of naproxen sodium, a nonsteroidal anti-inflammatory drug, for extended pain control. The single-dose formulation begins working in less than 30 minutes and provides pain relief for up to 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, 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 Company fiacetaminophen 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.
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.
“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 Dr. Todd Bertoch, 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.
