FDA Approves Another Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
The spray can be purchased without a prescription in convenience stores.
Jun 19, 2026
The U.S. Food and Drug Administration (FDA) has approved another over-the-counter nasal spray for emergency treatment of opioid overdose that can be sold without a prescription at convenience stores.
The intranasal naloxone product, Rextovy, was approved earlier this week. The standard treatment for opioid overdoses, naloxone rapidly reverses the effects of an opioid overdose, according to an FDA news release.
“Reducing opioid overdose deaths is a top priority for FDA,” said Mike Davis, acting director of the Center for Drug Evaluation and Research, in the release. “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.”
The FDA approved a naloxone nasal spray, Narcan, for use without a prescription for the first time in 2023.
The FDA said in this week’s release that there were 68,632 overdose deaths reported in the 12 months ending in December 2025, down 38.4% from 111,451 reported overdose deaths in the 12 months ending in August 2023. The agency said drug overdose remains a “major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl.”
Last year, Nashville-based convenience store Twice Daily installed a naloxone vending machine at a store in collaboration with Fund Recovery.
Cumberland Farms also partnered in 2024 with local health authorities to provide “NaloxBoxes” containing four doses of naloxone.
Rextovy’s packaging includes pictorial directions with five steps, the FDA said, including calling 911 after the first dose. Some might experience shaking, sweating, nausea or feeling angry after regaining consciousness following overdose reversal when using Rextovy, the FDA said.
