Published: 08/24/2026 | Author: Peter Lee

Anyone who keeps over the counter naloxone in a bag, a glovebox, or a kitchen drawer has a third option as of this summer. The Food and Drug Administration has approved Rextovy, a 4 milligram naloxone hydrochloride nasal spray, for nonprescription sale.

It is approved for the emergency treatment of known or suspected opioid overdose in adults and children, and it can be bought in pharmacies, convenience stores, and online.

What Over the Counter Naloxone Access Actually Changes

Rextovy comes from Amphastar Pharmaceuticals and is supplied in a carton holding two intranasal devices, each delivering a single 4 mg spray. If there is no response after two minutes, a second dose can be given in the other nostril.

It is the third nonprescription intranasal naloxone product to reach the market. Narcan, made by Emergent BioSolutions, was the first to receive over the counter status in 2023. RiVive, a 3 mg spray from the nonprofit Harm Reduction Therapeutics, followed.

All three contain the same active ingredient and are approved for use by bystanders with no medical training. Mike Davis, acting director of the FDA’s Center for Drug Evaluation and Research, said the approval broadens access and gives consumers another option.

The agency noted that having multiple approved formulations expands market availability, encourages competition that may reduce cost, and creates alternative sourcing options. Cost has been a real barrier. The prescription version has sold in the range of $44 to $60 per box.

The Opioid Crisis by the Numbers

The FDA framed the approval against a backdrop of falling but still severe overdose mortality. Overdose deaths have declined substantially since the first over the counter naloxone approval in 2023, though drug overdose remains a major public health problem in the United States, driven primarily by synthetic opioids like illicit fentanyl.

The approval is aligned with the federal Great American Recovery Initiative, a coordinated federal effort covering prevention, addiction treatment, and long-term recovery.

Understanding Naloxone and Opioid Overdose

Naloxone is an opioid antagonist. It binds to the same receptors that opioids act on and displaces them, which restores normal breathing in someone whose respiration has slowed or stopped from an opioid overdose. It works on fentanyl, heroin, oxycodone, hydrocodone, morphine, and methadone.

Signs of an opioid overdose include very slow or stopped breathing, blue or gray lips and fingertips, pinpoint pupils, limpness, and unresponsiveness to shouting or a sternal rub.

Two limits are worth knowing. High-potency fentanyl may require more than one dose. And naloxone does not reverse the veterinary sedatives such as xylazine and medetomidine that are increasingly mixed into the illicit supply.

Someone may start breathing after naloxone and stay heavily sedated. Emergency medical services should be called immediately after the first dose in every case.

People regaining consciousness after an overdose reversal may experience shaking, sweating, nausea, or anger. That reaction is expected. Naloxone is still considered safe to give when it is unclear whether opioids are involved.

Harm Reduction and Treatment for Opioid Addiction

Naloxone keeps someone alive long enough to have options. It is not treatment for opioid addiction, and the two work best together.

Medication for opioid use disorder, including methadone, buprenorphine, and naltrexone, has the strongest evidence base for treating opioid addiction and is available through opioid treatment programs and many outpatient providers.

Fentanyl test strips, safer use supplies, and syringe services programs reduce risk for people who are still using.

Peer support fills a different role. Narcotics Anonymous meetings are free, run by people in recovery, and available in person and online across the country, with formats that include open and closed meetings, beginner meetings, Spanish-language meetings, and virtual options.

Some people use NA alone, some use medication alone, and many use both. Narcotics.com is not affiliated with Narcotics Anonymous World Services, Inc.

Finding Help for Opioid Addiction

If you are looking for a starting point, a few specific steps help:

Pick up naloxone. With three approved products on the market, over the counter naloxone is available without a prescription at pharmacies and many convenience stores, and free through many local harm reduction programs and health departments.

Search NA meetings in your city or state to find a meeting this week, including virtual options if getting there is difficult. Ask any opioid treatment program whether it can start medication at the first visit rather than after a waiting period. Call 800-934-1582(Sponsored) to find out more about treatment options in your area.