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July 27, 2026

Kenvue’s Tylenol with Naproxen gains FDA approval

The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen (650mg) and naproxen sodium (220mg).

The FDA approval grants Kenvue a three-year exclusivity period for the new OTC formulation. Credit: DC Studio / Shutterstock.com.