On Jun. 16, 2026, the U.S. Food and Drug Administration (FDA) approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. Consumers may directly purchase this product without a prescription in places such as pharmacies, convenience stores, and online.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. Rextovy is an additional life-saving medication approved by the FDA to reverse an opioid overdose to be sold directly to consumers and contains the same active ingredient as other naloxone nasal sprays. The availability of multiple approved formulations expands access and market availability, encourages competition that may reduce cost, and offers alternative sourcing options.

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. 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.