The U.S. Food and Drug Administration approved a third over-the-counter naloxone nasal spray on June 16, 2026, broadening public access to the opioid overdose reversal medication. The new product, called Rextovy — a 4-milligram naloxone hydrochloride nasal spray manufactured by Amphastar Pharmaceuticals — is now available for direct purchase without a prescription at pharmacies, convenience stores, and online.
Naloxone reverses opioid overdose by blocking opioid receptors in the brain. When administered to someone who has stopped breathing or lost consciousness due to opioid overdose — including fentanyl overdose — it can restore normal breathing within two to three minutes. A person who has overdosed cannot administer it to themselves. Only a bystander, family member, or first responder can deliver the medication in time.
The FDA's approval of Rextovy makes it the third naloxone nasal spray available over the counter in the United States, joining Narcan (Emergent BioSolutions) and RiVive (Harm Reduction Therapeutics). Having three competing products available without a prescription is expected to expand access and put downward pressure on retail pricing.
Why This Matters
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 — a meaningful decline that public health researchers attribute in significant part to expanded naloxone access.
But thousands of deaths still occur in the presence of people who might have saved a life if they had naloxone on hand. Drug overdose persists as a major public health issue, primarily driven by synthetic opioids like illicit fentanyl, which is now present in a wide range of street drugs, including methamphetamine, cocaine, and counterfeit pills, meaning overdose risk has expanded far beyond people who identify as opioid users.
What We Know So Far
The three available OTC naloxone nasal sprays are:
- Narcan (Emergent BioSolutions) — 4 mg naloxone nasal spray; first OTC naloxone product, approved September 2023
- Rextovy (Amphastar Pharmaceuticals) — 4 mg naloxone nasal spray; FDA-approved June 16, 2026
- RiVive (Harm Reduction Therapeutics) — 3 mg naloxone nasal spray
All three products work through the same mechanism — blocking opioid receptors — and are administered by spraying into one nostril. If no response occurs within two to three minutes, a second dose should be administered in the other nostril. Emergency medical services should be called immediately after giving the first dose.
The product's packaging includes step-by-step pictorial instructions with five clear steps, including calling 911 after giving the first dose.
Where Overdose Risk Is Concentrated
States with historically high fentanyl overdose death rates include West Virginia, Kentucky, Ohio, Tennessee, Delaware, Pennsylvania, Connecticut, and Maryland. Anyone who uses illicit drugs in any form faces an elevated risk, given the widespread fentanyl contamination of the drug supply. People leaving incarceration face dramatically elevated overdose risk in the days after release — when tolerance is low, and exposure may be high.
What Doctors and Experts Say
"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. "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."
Harm reduction advocates note that the critical challenge is no longer regulatory. The challenge is distribution: getting naloxone into the hands of people in highest-risk situations, including those who may not go to pharmacies, those who lack transportation, and communities where stigma around drug use remains a barrier.
What the Evidence Shows — and What It Does Not
Naloxone is one of the most rigorously evidence-supported medications in emergency medicine. Its ability to reverse opioid overdose is not contested. Because illicit fentanyl is significantly more potent than traditional opioids, some people with high opioid tolerance may require more than one dose of naloxone to achieve reversal. The standard guidance — administer a second dose if there is no response in two to three minutes — remains valid.
Post-reversal symptoms such as shaking, sweating, nausea, or feeling angry may occur as the person enters acute opioid withdrawal. These are expected and manageable, but the person should be kept calm and monitored until emergency services arrive.
Who Should Have Naloxone at Home
- Anyone who uses prescription opioid pain medication, especially at high doses
- Households with a family member or close friend who uses any illicit drugs
- Anyone leaving a period of abstinence or incarceration — when tolerance is low, and overdose risk is highest
- First responders, teachers, coaches, and anyone who works with the public in communities with elevated overdose rates
- Anyone who simply wants to be prepared to help a stranger during a medical emergency
Symptoms of Opioid Overdose to Recognize
- Unresponsiveness or loss of consciousness
- Slow, shallow, or stopped breathing
- Choking, gurgling, or snoring sounds
- Blue or gray lips or fingertips
- Pinpoint (very small) pupils
- Pale, cold, or clammy skin
If any of these signs are present, call 911 immediately, administer naloxone, and stay with the person until emergency responders arrive.
What You Can Do Now
- Get naloxone. Narcan, RiVive, and Rextovy are available at most major pharmacy chains without a prescription. Ask the pharmacist if you cannot find it on the shelf.
- Know how to use it. Read the instructions before an emergency. Place one spray in one nostril, call 911, repeat in the other nostril after two to three minutes if needed. Keep the person on their side.
- Ask for free options if cost is a barrier. Most state health departments distribute naloxone free through harm reduction organizations and community health centers. Call SAMHSA's National Helpline at 1-800-662-4357 for referrals.
- Carry it. Having naloxone stored at home is useful, but carrying it — particularly at social events or when spending time with someone in recovery — can be the difference between a reversible and irreversible outcome.
- Co-prescribe. If you or a family member is prescribed any opioid pain medication, ask the prescribing clinician to include a naloxone co-prescription at the same visit.
Cost and Access: What Patients Should Know
The average retail price for a two-dose kit is approximately $45 to $65. Most insurance plans — including Medicare Part D and all state Medicaid programs — cover naloxone with little or no copay. Free naloxone is available in all 50 states through harm reduction organizations and state programs. The SAFE Project's state-by-state naloxone access guide at safeproject.us/naloxone provides current information on pharmacy standing orders and distribution programs.
The Bottom Line
The FDA's approval of Rextovy on June 16, 2026, adds a third OTC naloxone nasal spray to pharmacy shelves, expanding market competition and potentially reducing cost for the opioid overdose reversal medication. All three OTC products work the same way and are effective against fentanyl overdose — though repeat dosing may be needed for high-tolerance fentanyl users. The most important action any person in a high-risk household or community can take is to obtain naloxone before a crisis occurs.
