The FDA on June 16 approved Rextovy, a 4-milligram naloxone hydrochloride nasal spray, for over-the-counter use.
The decision aligns with President Donald Trump’s federally coordinated effort to address the addiction and substance use crisis across the U.S., according to a June 16 news release from the agency. In the 12-month period ending in August 2023, 111,451 overdose deaths were reported. In the 12-month period ending in December 2025, 68,632 overdose deaths were reported.
Here are four things to know:
- Rextovy will be available directly to consumers at pharmacies, convenience stores and online.
- The product is approved for the emergency treatment of opioid overdose and contains the same active ingredient as other naloxone nasal sprays.
- The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, according to the release.
- Rextovy’s instructions include five clear steps, including calling 911 after administering the first dose. The product can be used even when it is uncertain whether opioids are present in a person’s system.
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