WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Rextovy, an over-the-counter naloxone nasal spray for emergency treatment of opioid overdoses, expanding consumer access to a medication widely viewed as a frontline tool in preventing overdose deaths.
The approval allows consumers to purchase the 4-milligram naloxone hydrochloride nasal spray without a prescription at pharmacies, convenience stores, and online retailers, the agency announced.
The decision adds another nonprescription naloxone product to the market as federal health officials seek to reduce overdose fatalities and broaden public access to overdose-reversal medications.
Naloxone rapidly reverses the effects of opioid overdoses and has become a standard emergency intervention amid the nation’s ongoing opioid crisis. Rextovy contains the same active ingredient found in other naloxone nasal sprays already available to consumers.
FDA officials indicated that additional market entrants could improve availability and increase competition among manufacturers, potentially lowering costs and reducing supply constraints.
“Today’s approval of an additional over-the-counter naloxone nasal spray helps broaden access and offers an additional option for consumers,” Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, stated. “Empowering people without medical training to take immediate action with these products has been proven to save lives.”
The approval comes as overdose deaths have declined significantly since the FDA authorized the first over-the-counter naloxone nasal spray in 2023.
According to agency data, the United States recorded 111,451 overdose deaths during the 12-month period ending in August 2023. That figure fell to 68,632 deaths during the 12-month period ending in December 2025. Despite the decline, the FDA noted that overdose deaths remain a major public health challenge, driven largely by synthetic opioids such as illicit fentanyl.
The agency emphasized that naloxone should be administered immediately when an overdose is suspected and that the medication is considered safe even when it is unclear whether opioids are present in a person’s system.
Rextovy’s packaging includes illustrated instructions and directs users to call 911 after administering the initial dose.
Karen Murry, director of the FDA’s Office of Nonprescription Drug Products, described broad access to naloxone as critical during overdose emergencies and encouraged additional manufacturers interested in developing nonprescription naloxone products to engage with the agency.
The FDA granted the approval to Amphastar Pharmaceuticals Inc.
For more information about naloxone products and opioid overdose prevention, visit the FDA’s website at fda.gov.
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