FDA approves third over-the-counter opioid overdose nasal spray

The Food and Drug Administration (FDA) approved a third over-the-counter version of naloxone nasal spray Tuesday, in a move the agency said could save lives and reduce costs.

The agency approved another Rextovy, a 4 milligram naloxone nasal spray for the emergency treatment of opioid overdose. FDA said consumers may directly buy it in pharmacies, convenience stores and online.

Naloxone is a medicine that can help reduce opioid overdose deaths and when administered in time, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.

Rextovy is the third naloxone spray approved for use without a prescription, and FDA said having multiple approved formulations expands access and market availability, encourages competition that may reduce cost, and offers alternative sourcing options.

The prescription version sells between $44 to $60 per box, but pricing for the over-the-counter version wasn’t immediately available.

The approval “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,” Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

The product is safe to use even when it is uncertain whether opioids are present in the person’s system. The product’s packaging includes picture directions with five clear steps, including calling 911 after giving the first dose.

The number of overdose deaths has dramatically decreased since the first FDA approval of an OTC naloxone nasal spray in 2023, but drug overdose persists as a major public health issue in the U.S., primarily driven by synthetic opioids like illicit fentanyl, FDA said.

In the 12-month period ending in August 2023, 111,451 overdose deaths were reported; in the 12-month period ending in December 2025, 68,632 overdose deaths were reported, according to federal figures.

The first naloxone nasal spray, Narcan, was approved in 2015 to treat known or suspected opioid overdoses for people of all ages, including newborns.

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