WASHINGTON (WDNews) — The U.S. Food and Drug Administration has approved another over-the-counter naloxone nasal spray product, expanding public access to a medication used to reverse opioid overdoses.
According to the FDA, the newly approved product, Rextovy, is a 4-milligram naloxone hydrochloride nasal spray that can be purchased without a prescription at pharmacies, convenience stores and online retailers.
FDA officials said the approval provides consumers with another option for emergency opioid overdose treatment and could help increase access to life-saving medication.
“Reducing opioid overdose deaths is a top priority for FDA,” said Mike Davis, M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research (CDER). “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.”
Naloxone rapidly reverses the effects of an opioid overdose and is considered the standard treatment for opioid overdose emergencies. The FDA said Rextovy contains the same active ingredient as other naloxone nasal sprays already on the market.
The agency noted that having multiple approved over-the-counter naloxone products available may improve access, increase competition and potentially lower costs for consumers.
According to the FDA, overdose deaths have declined significantly since the first over-the-counter naloxone nasal spray was approved in 2023. The agency reported 111,451 overdose deaths during the 12-month period ending in August 2023, compared to 68,632 deaths during the 12-month period ending in December 2025.
“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 Karen Murry, M.D., Director of the Office of Nonprescription Drug Products in CDER. “We are proud of the dedicated work our review divisions put into making this approval possible, and we encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”
The FDA said some people may experience symptoms such as shaking, sweating, nausea or anger after regaining consciousness following an overdose reversal. The agency also noted that the product is safe to use even when it is unclear whether opioids are present in a person’s system.
The packaging includes pictorial instructions and advises users to call 911 after administering the first dose.
The FDA granted nonprescription approval of Rextovy to Amphastar Pharmaceuticals, Inc.
