The U.S. Food and Drug Administration (FDA) has approved Rextovy, a 4 mg naloxone hydrochloride nasal spray, for over-the-counter (OTC) use. The product can now be purchased directly by consumers without a prescription.
With this approval, people will be able to buy Rextovy from pharmacies, convenience stores, and online retailers, making it easier to access emergency treatment for opioid overdoses when every second counts.
The nonprescription approval was granted to Amphastar Pharmaceuticals, Inc.
The approval aligns with the Trump Administration’s Great American Recovery Initiative, a federal effort focused on addressing addiction and substance use disorders across the United States.
The initiative aims to improve prevention, treatment, and long-term recovery options while reducing the devastating impact of opioid misuse on individuals, families, and communities.
FDA officials say increasing access to naloxone remains a key part of that strategy.
Naloxone is widely recognized as the standard emergency treatment for opioid overdose. The medication works by quickly reversing the effects of opioids and restoring normal breathing in people experiencing an overdose.
Rextovy contains the same active ingredient found in other approved naloxone nasal sprays and is designed to be used by people without medical training.
According to the FDA, having additional OTC naloxone products available gives consumers more choices and improves access to potentially life-saving treatment.
Mike Davis, Acting Director of the FDA's Center for Drug Evaluation and Research (CDER), said that broadening access to naloxone products has already demonstrated its ability to save lives by allowing immediate action during overdose emergencies.
More Competition Could Improve Availability and Affordability
The approval of another nonprescription naloxone product may also help strengthen supply and availability across the market.
Health officials note that having multiple approved formulations can:
These factors can be especially important in communities where opioid overdoses remain a significant public health concern.
Overdose Deaths Have Declined but the Crisis Continues
Since the first FDA approval of an OTC naloxone nasal spray in 2023, overdose deaths in the United States have shown a significant decline.
According to FDA-referenced data, approximately 111,451 overdose deaths were reported during the 12-month period ending in August 2023. By the 12-month period ending in December 2025, that number had decreased to 68,632.
Despite this progress, opioid overdoses continue to be a major public health challenge. Synthetic opioids, particularly illicit fentanyl, remain the primary driver of overdose-related deaths across the country.
FDA Encourages More Nonprescription Naloxone Products
Karen Murry, Director of the Office of Nonprescription Drug Products within CDER, emphasized the importance of making naloxone products readily available to the public.
She noted that immediate access to naloxone nasal sprays can be critical during an overdose emergency and said the FDA remains committed to supporting broader availability of nonprescription overdose-reversal products.
The agency has also encouraged manufacturers interested in developing OTC naloxone products to engage with the FDA early in the development process.
What Consumers Should Know About Rextovy
When a person regains consciousness after receiving naloxone, they may experience temporary withdrawal-related symptoms.
Some commonly reported reactions include:
The FDA noted that Rextovy is safe to use even when it is unclear whether opioids are present in a person's system.
To make administration easier during emergencies, the product packaging includes illustrated instructions that guide users through the process step by step. The instructions also emphasize the importance of calling 911 immediately after the first dose is administered.
Growing Availability of Naloxone Continues to Support Public Health Efforts
The approval of Rextovy adds another nonprescription option to the growing naloxone market and further expands access to emergency overdose treatment across the United States.
As public health agencies continue working to reduce opioid-related deaths, wider availability of overdose-reversal products remains an important tool in helping individuals, families, and communities respond quickly during life-threatening situations.