Prescription and over-the-counter medicine
Naloxone Brand names: Narcan, Rivive, Rextovy, Zimhi, Rezenopy
Naloxone (Narcan) is a prescription and over-the-counter medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 41 generic labelers, and pharmacies paid $12.74 per mL (Naloxone 2 mg/2 mL syringe) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the naloxone FDA label on DailyMed (effective August 17, 2026, Emergent Devices Inc.); the NDA 16636 record on Drugs@FDA; every naloxone label on DailyMed.
Highlights of the record
FDA label of August 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageto “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
Forms and strengths
- 0.4 mg/ml
- 1 mg/ml
- 3 mg/.1ml
- 4 mg/.1ml
- 4 mg/.25ml
- 5 mg/.5ml
- 8 mg/.1ml
- 10 mg/.4ml
- 10 mg/.11ml
Injection (solution); spray; injection; spray (metered); inhalant.
On the market
- Earliest approval on file
- April 13, 1971 Narcan, Adapt; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 53 first October 2, 1985; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 48 of which 41 under generic applications, 11 under brand applications, repackagers included
- Last listed patent
- June 14, 2041 Zimhi injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $12.74 per mL Naloxone 2 mg/2 mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 1 Class I among all firms' recalls; latest March 15, 2021; 2 more by firms not listed as its makers
- FAERS reports
- 5,543 through July 30, 2026
What is naloxone used for?
From the label: indications and usageto “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
FDA pharmacologic class: Opioid Antagonist.
Source: FDA drug label (NARCAN), Emergent Devices Inc., effective August 17, 2026 (SPL set a0ebc83d-2892-40de-bc0a-775ce90b30db), via openFDA; the full label on DailyMed
What does the patient leaflet for naloxone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ZIMHI ?ZIMHI is used to temporarily reverse the effects of opioid medicines. The medicine in ZIMHI has no effect in people who are not taking opioid medicines. Always carry ZIMHI with you in case of an opioid emergency. Use ZIMHI right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include: unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum) breathing problems including slow or shallow breathing in someone difficult to awaken or they look like they are not breathing the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils” in someone difficult to awaken Family members, caregivers, or other people who may have to use ZIMHI in an opioid emergency should know where ZIMHI is stored and how to give ZIMHI before an opioid emergency happens. Make sure everyone reads the information contained in the case and carton as soon as you receive ZIMHI. ZIMHI is intended to be given by people 12 years of age or older. Younger children or those with limited hand strength may find the Pre-filled syringe difficult to use. Get emergency medical help right away after using the first dose of ZIMHI . Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help. The signs and symptoms of an opioid emergency can return after ZIMHI is given. If this happens, give additional injections using a new ZIMHI pre-filled syringe every 2 to 3 minutes and watch the person closely until emergency help is received. […]
From the patient leaflet: How should I store ZIMHI ?Store below 77°F (25°C). Excursions permitted up to 104°F (40°C). Do Not Freeze or expose to excessive heat above 104°F (40°C). Protect from Light. During storage, check ZIMHI often through the viewing window of the pre-filled syringe. The solution should be clear. If the ZIMHI solution is discolored, cloudy, or contains solid particles, replace it with a new ZIMHI. Your ZIMHI has an expiration date. Replace it before the expiration date. Keep ZIMHI and all medicines out of the reach of children.
Source: FDA drug label (ZIMHI), ZMI Pharma Inc., effective December 4, 2025 (SPL set 523c0909-bff6-4010-988a-53de18b7cb3f), via openFDA; the full label on DailyMed
Is there a generic for naloxone (Narcan)?
The FDA approved the first generic naloxone on October 2, 1985. 53 generic applications are approved; 28 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists naloxone from 41 labelers under a generic (ANDA) application and from 11 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Narcan spray; a patent listed only for Zimhi injection runs to June 14, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1971 earliest approval on file
- 1985 first generic approved
- 2041 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for naloxone (Narcan)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $12.74 per mL (Naloxone 2 mg/2 mL syringe), up 13% from $11.29 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Naloxone 2 mg/2 mL syringe (generic)
- Narcan 4 mg nasal spray (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ft naloxone HCl 4 mg nasal spr | Generic | $17.18 per unit | n/a | -25% |
| Gnp naloxone HCl 4 mg nasal sp | Generic | $17.18 per unit | n/a | -25% |
| Naloxone 0.4 mg/mL vial | Generic | $3.82 per mL | n/a | -21% |
| Naloxone 2 mg/2 mL syringe | Generic | $12.74 per mL | $25.48 per syringe | +13% |
| Naloxone 4 mg/10 mL vial | Generic | $3.82 per mL | $38.24 per vial | -21% |
| Naloxone HCl 4 mg nasal spray | Generic | $17.18 per unit | n/a | -25% |
| Kloxxado 8 mg nasal spray | Brand | $59.77 per unit | n/a | -0.3% |
| Narcan 4 mg nasal spray | Brand | $16.45 per unit | n/a | -20% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has naloxone been recalled?
The FDA's Enforcement Report lists 4 recalls naming naloxone since 2013: 1 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of naloxone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Akorn, Inc. not a listed maker | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 4, 2018 | Class I | HOSPIRA INC, LAKE FOREST | Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the naloxone label say about other medicines?
The naloxone label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 38 other medicines name naloxone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | warnings and precautions | Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete. |
Other labels that name naloxone
Source: FDA drug label (NARCAN), Emergent Devices Inc., effective August 17, 2026 (SPL set a0ebc83d-2892-40de-bc0a-775ce90b30db), via openFDA; the full label on DailyMed
What do FAERS reports show for naloxone?
The FDA Adverse Event Reporting System holds 5,543 reports that list naloxone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 824 are coded as a death and 2,103 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other opioid antagonists
- the pharmacologic class, with prices and generics
- Naloxone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other