The U.S. Food and Drug Administration has approved Rextovy (naloxone hydrochloride) 4 mg nasal spray for sale without a prescription, according to an FDA announcement dated June 16, 2026. It becomes the second naloxone nasal spray available over the counter, following Narcan’s switch in 2023.
What was approved
Rextovy contains the same active ingredient and dose as other approved naloxone nasal sprays and is intended for emergency use in a known or suspected opioid overdose. Reporting on the approval notes that the packaging includes illustrated instructions and directs users to call 911 after giving the first dose. As with any OTC medicine, people should read and follow the Drug Facts label.
Part of a broader trend
The approval fits a wider FDA effort, under Commissioner Martin Makary, to make more medicines available without a prescription by speeding up prescription-to-OTC switches and using a pathway that allows additional conditions for nonprescription use. Commentators see benefits for access and convenience, alongside regulatory, safety and commercial questions that each switch has to address.
What it means for pharmacies and retailers
Each switch can change what retailers, clinics, schools and community organisations are able to stock and distribute. Agentic Rx supplies OTC medicines, vitamins and medical supplies in the United States and across the Americas, and we track switches so we can help customers plan inventory. Contact us if you are looking to source specific OTC products.
This article summarises public reporting for general information. It is not medical, legal or regulatory advice. Please check the original sources and current rules before acting.
