FDA approves first OTC combo of Tylenol and Naproxen for ‘non-opioid’ pain relief
The FDA recently approved a new over-the-counter pain medication that combines Tylenol and Naproxen into a single tablet. This development marks the first fixed-dose, nonprescription combination of these two popular pain relief drugs, providing a new option for adults and children 12 years and older.
Kenvue Brands, the manufacturer behind the product, noted that the medication is intended to provide up to 12 hours of relief. According to company data from eight clinical studies, the combination tablet demonstrated superior efficacy compared to taking either medication on its own. It also aims to reach peak relief within 30 minutes of administration.
This approval offers a simplified alternative for patients who currently manage persistent pain through complex, multi-step routines. By combining two distinct pain management ingredients into one dose, the product supports better patient adherence. It serves as an additional non-opioid choice for individuals seeking relief without a prescription.
The regulatory decision arrived on July 24, with Kenvue framing the move as a way to streamline consumer pain management. The tablets will be accessible on store shelves, representing a clear shift in how everyday pain relief is delivered and consumed.