WASHINGTON — A new over-the-counter medication will soon be available to help reverse opioid overdoses.
The U.S. Food and Drug Administration announced this week it has approved Rextovy, a 4-milligram naloxone hydrochloride nasal spray, for nonprescription use. It will be available for purchase without a prescription at pharmacies, convenience stores and online.
Naloxone is a medication that rapidly reverses the effects of an opioid overdose if administered shortly after an overdose and is considered the standard treatment.
“Immediate access to naloxone nasal sprays is essential when a person is experiencing an overdose, and FDA remains committed to ensuring nonprescription options are widely available,” said Dr. Karen Murry, director of the Office of Nonprescription Drug Products in the FDA’s Center for Drug Evaluation and Research, in a news release.
The approval expands access to overdose-reversal medications following the FDA’s first over-the-counter naloxone approval in 2023. That move came as overdose deaths were rising sharply.
More recently, the Centers for Disease Control and Prevention reported a 13.9% decrease in overdose deaths in 2025. Many experts point to increased access to naloxone as one factor in the decline.
Despite that progress, the FDA says drug overdoses remain a significant public health issue, largely driven by synthetic opioids such as illicit fentanyl. In the 12 months ending in December 2025, the CDC reported 68,632 overdose deaths.
“Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers. Empowering people without medical training to take immediate action with these products has been proven to save lives,” said Dr. Mike Davis, acting director of the Center for Drug Evaluation and Research.
The FDA says people who receive Rextovy may experience withdrawal symptoms after regaining consciousness, including shaking, sweating, nausea or agitation. The agency says the medication is safe to use even if it is unclear whether opioids are present.
The product packaging includes step-by-step instructions, including a reminder to call 911 after administering the first dose.
