Rextovy, a 4 mg naloxone medication, will be available for purchase without a prescription at retail stores and online.
RT’s Three Key Takeaways:
- Emergency Preparedness: The medication is designed for use by individuals without medical training and includes pictorial instructions to guide users through the five-step administration process.
- Increased Access: The Food and Drug Administration (FDA) approved Rextovy for over-the-counter use, allowing consumers to buy the opioid overdose reversal medication without a prescription at pharmacies and convenience stores.
- Lower Mortality Rates: National overdose deaths decreased from 111,451 in the year ending August 2023 to 68,632 in the year ending December 2025, according to federal data.
The USFDA approved 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.
“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 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.1
When using Rextovy, some people may experience symptoms when they regain consciousness following overdose reversal, such as shaking, sweating, nausea, or feeling angry. 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 pictorial directions with five clear steps, including calling 911 after giving the first dose.
The FDA granted the nonprescription approval to Amphastar Pharmaceuticals, Inc.
Reference from FDA
1 Products – Vital Statistics Rapid Release – Provisional Drug Overdose Data
