As reported on Pharmaceutical Technology, Kenvue has received US Food and Drug Administration (FDA) approval for an over-the-counter (OTC) pain medication that combines acetaminophen and naproxen sodium in a single fixed-dose tablet. According to the company, the newly approved product, Tylenol with Naproxen, is the first nonprescription treatment in the United States to pair these two widely used pain-relief ingredients in one formulation.
The product contains 650 mg of acetaminophen and 220 mg of naproxen sodium. By combining the rapid pain-relieving effects commonly associated with acetaminophen and the longer-lasting anti-inflammatory action of naproxen sodium, Kenvue aims to offer consumers a convenient non-opioid option for managing ongoing pain symptoms without a prescription.
Company data indicate that the medication can begin providing relief in less than 30 minutes and may remain effective for up to 12 hours. Kenvue said the approval was supported by findings from eight clinical studies that compared the combination product with treatments containing either acetaminophen or naproxen sodium alone. The results reportedly demonstrated superior pain control with the dual-ingredient formulation compared with each individual component.
The approval comes amid continued demand for effective non-opioid pain-management strategies. Kenvue pointed to findings from its March 2026 Pain Consumer Survey, which included 6,240 participants. Nearly three-quarters of respondents living with persistent pain reported dissatisfaction with currently available pain-relief approaches, highlighting a significant unmet need among consumers.
Commenting on the approval, Rajesh Mishra, MD, chief medical officer at Kenvue, said the new product was designed to simplify pain-management decisions by combining fast onset and extended duration in a single OTC medication. He emphasized that the formulation brings together two well-established non-opioid active ingredients with long histories of use.
The FDA’s decision also grants Kenvue three years of market exclusivity for the new OTC combination. The company expects Tylenol with Naproxen to become available at major retailers throughout the United States in the near future.
The launch expands the Tylenol portfolio and introduces an additional option for consumers seeking longer-lasting pain relief without turning to prescription therapies or opioid-based medications.
