FDA Approves OTC Acetaminophen-Naproxen Combination for Pain Relief
KEY TAKEAWAYS
- The FDA approved Tylenol with Naproxen, an over-the-counter fixed-dose combination of acetaminophen 650 mg and naproxen sodium 220 mg.
- The product is designed to provide opioid-free pain relief with onset in under 30 minutes and duration up to 12 hours.
- Approval was supported by 8 clinical studies showing greater pain relief versus either acetaminophen or naproxen sodium alone.
The Food and Drug Administration (FDA) approved Tylenol with Naproxen (acetaminophen 650 mg/naproxen sodium 220 mg; Kenvue, Summit, NJ), an over-the-counter fixed-dose combination for pain relief. The product combines acetaminophen with naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID), in a single oral dose.
According to Kenvue, the approval expands nonopioid OTC options for people with persistent pain and may help simplify pain management for individuals who otherwise use multiple OTC analgesics with separate dosing schedules. The FDA also granted a 3-year period of exclusivity for the new OTC formulation.
Clinical Data Highlights
- In 8 clinical studies, the fixed-dose combination showed superior pain relief compared with acetaminophen alone and naproxen sodium 220 mg alone.
- The company reported onset of relief in under 30 minutes.
- A single dose provided pain relief for up to 12 hours.
- Additional clinical data across multiple pain models are expected to be presented at PAINWeek 2026 and other medical meetings.
Tylenol with Naproxen is expected to become available at major US retailers. As with other acetaminophen- and NSAID-containing products, labeling and dosing instructions will be important to reduce risks related to overlapping ingredients or inappropriate use.
Source
Kenvue. FDA approves Tylenol with Naproxen, the first and only over-the-counter fixed-dose combination of acetaminophen (650 mg) and naproxen sodium (220 mg). PR Newswire. Published July 24, 2026. Accessed July 27, 2026. https://www.prnewswire.com/news-releases/fda-approves-tylenol-with-naproxen-the-first-and-only-over-the-counter-fixed-dose-combination-of-acetaminophen-650-mg-and-naproxen-sodium-220-mg-302834313.html