WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) today approved Rextovy, another over-the-counter (OTC) intranasal naloxone product, significantly broadening public access to the life-saving medication. Rextovy is a 4 milligram (mg) naloxone hydrochloride nasal spray designed for the emergency treatment of a known or suspected opioid overdose.
With this nonprescription approval, consumers will be able to purchase Rextovy directly without a prescription in traditional retail spaces such as pharmacies and convenience stores, as well as through online marketplaces. This action aligns with federal efforts under the Great American Recovery Initiative, which coordinates the government’s approach to prevention, treatment, and long-term recovery to address the nation’s addiction and substance use disorder crisis.
“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.”
Expanding Access and Driving Competition
Naloxone is the standard medical countermeasure used to rapidly reverse the respiratory-depressing effects of an opioid overdose. Rextovy contains the same active ingredient as previously approved naloxone nasal sprays. Public health officials note that the availability of multiple approved OTC formulations expands consumer choice, encourages market competition that may reduce retail costs, and offers alternative sourcing options for community health groups.
The impact of making these emergency treatments widely available is already reflected in national health statistics. While drug overdose persists as a critical public health issue—primarily driven by illicit synthetic opioids like fentanyl—the number of annual overdose deaths in the U.S. has decreased dramatically since the first OTC naloxone nasal spray approval in 2023. In the 12 months ending in August 2023, 111,451 overdose deaths were reported nationwide. By comparison, that number dropped to 68,632 reported deaths in the 12 months 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 encourage any manufacturer seeking to market a nonprescription naloxone product to contact the agency to initiate a conversation.”
Safety and Ease of Use
Rextovy is designed to be administered easily by individuals without formal medical training. To facilitate quick action during a high-stress medical emergency, the product’s packaging includes prominent pictorial directions outlining five clear steps. The instructions emphasize that bystanders should call 911 immediately after administering the first dose.
The medication is completely safe to use, even if it is ultimately uncertain whether opioids are present in the individual’s system. The FDA notes that when a patient regains consciousness following an overdose reversal, they may experience standard opioid withdrawal symptoms, including shaking, sweating, nausea, or irritability.
The FDA granted the nonprescription approval of Rextovy to Amphastar Pharmaceuticals, Inc.
