Naloxone
Naloxone is an opioid-reversing medicine used mainly for emergency treatment of known or suspected opioid overdose, with some injection products also used in hospital-type settings and for specific military and chemical-incident uses.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 55 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Naloxone (Narcan and others) is the standard emergency rescue for an opioid overdose, competing with opioids for their receptors (the docking sites they attach to) so slowed breathing recovers, and it has been on the market since about 1971 and is available generically, with some nasal sprays sold over the counter. With no opioids on board it does very little, but in someone dependent on opioids it can bring sudden withdrawal (aches, sweating, nausea, vomiting, shaking), and the spray can irritate the nose. It does not replace emergency care, since it can wear off before the opioid does, so call 911 after the first dose and stay with the person.
Clinical pearls
- Keep it where family and friends know to find it, because someone else almost always has to give it.
- Buprenorphine (Suboxone) or pentazocine overdoses may only partly reverse, so be ready to give repeat doses.
- A child who wakes up still needs close watching for at least 24 hours, because symptoms can return.
- In pregnancy, still give it for an overdose, then have the fetus checked for distress afterward.
Patient information guide — a plain-language walkthrough of Naloxone, written from its FDA label.
What Naloxone is used for
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Naloxone is used to reverse the effects of opioids. Uses depend on the product.
- Naloxone nasal sprays (including Narcan, Kloxxado, Rextovy and Rezenopy) and Zimhi injection: emergency treatment of known or suspected opioid overdose.
- Naloxone hydrochloride injection: complete or partial reversal of opioid depression, including slowed breathing.
- Naloxone hydrochloride injection: helps diagnose suspected or known acute opioid overdose.
- Naloxone hydrochloride injection: may help raise blood pressure in septic shock.
- Naloxone hydrochloride auto-injector: for military personnel and chemical incident responders, for suspected high-potency opioids such as fentanyl analogues used as a chemical weapon, and for temporary protection when entering a contaminated area.
How Naloxone works
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Naloxone is an opioid antagonist. It competes with opioids for the same receptor sites, which blocks them. This reverses effects such as slowed breathing, sedation and low blood pressure. It can also reverse the unpleasant mental effects of mixed opioids like pentazocine.
Naloxone dosage
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Dosing depends on the product, so follow the label and your prescriber.
- Nasal sprays: one spray into one nostril. If there is no response, or breathing slows again, give more doses with a new spray every 2 to 3 minutes until help arrives.
- Zimhi: injected into the outer thigh muscle, through clothing if needed. It is for muscle or under-the-skin use only.
- Naloxone hydrochloride injection: given into a vein, muscle or under the skin, with the vein route fastest in emergencies. Repeat doses may be needed.
Always call for emergency help right after use.
Dosing details from the FDA-approved label
From the Naloxone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Zimhi (naloxone) injection: initial dose in adult or pediatric patients with known or suspected opioid overdose
- Administer the initial dose of ZIMHI intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary, and seek emergency medical assistance
- Administer as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death
- Intended to be administered by individuals 12 years of age or older
- Zimhi (naloxone) injection: repeat dosing
- If the desired response is not obtained after 2 or 3 minutes, an additional dose of ZIMHI may be administered
- If there is still no response and additional doses are available, additional doses may be administered every 2 to 3 minutes until emergency medical assistance arrives
- If the patient responds and relapses into respiratory depression before emergency
- Partial agonists or mixed agonist/antagonists such as buprenorphine and pentazocine may require higher doses of naloxone hydrochloride or repeated administration
- Zimhi (naloxone) injection: pediatric patients under age one year
- The caregiver should pinch the thigh muscle while administering ZIMHI
- Carefully observe the administration site for signs of infection following resolution of the opioid emergency
- Naloxone hydrochloride nasal spray: initial dose in suspected opioid overdose
- A single spray administered intranasally into one nostril
- Seek emergency medical care immediately after use
- Naloxone hydrochloride nasal spray: repeat dosing
- If the patient does not respond or responds and then relapses into respiratory depression, additional doses may be given every 2 to 3 minutes until emergency medical assistance arrives, using a new nasal spray with each dose, in alternate nostrils with each dose
Read the label’s full dosing text
2. DOSAGE AND ADMINISTRATION ZIMHI is for intramuscular or subcutaneous use only. ( 2.1 ) Seek emergency medical care immediately after use. ( 2.1 ) ZIMHI is intended to be administered by individuals 12 years of age or older. ( 2.1 ) Administer ZIMHI to adult or pediatric patients into the anterolateral aspect of the thigh, through clothing if necessary. ( 1 ) See the Full Prescribing Information and Instructions for Use for important information on how to safely administer ZIMHI. ( 2.1 ) Keep the patient under continued surveillance until emergency personnel arrive and administer repeated doses of ZIMHI as necessary. ( 2.1 ) Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance. ( 2.2 ) In pediatric patients under the age of one, the caregiver should pinch the thigh muscle while administering the dose. ( 2.2 ) 2.1 Important Administration Instructions ZIMHI is for intramuscular and subcutaneous use only. Because treatment of known or suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of ZIMHI and the Instructions for Use. ZIMHI is intended to be administered by individuals 12 years of age or older. Younger individuals or those with limited hand strength may find the device difficult to use. ZIMHI is light sensitive. Store ZIMHI in the outer case provided to protect it from light. Prior to a medical emergency (during storage), periodically visually inspect ZIMHI through the viewing window on the device. If the solution is discolored yellow or brown color, cloudy, or contains particles, replace ZIMHI with a new one [ see How Supplied/Storage and Handling ( 16.2 ) ]. Do not attempt to reuse ZIMHI. Each ZIMHI contains a single-dose of naloxone hydrochloride for single-dose injection. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZIMHI ® . Emphasize the following instructions to the patient or caregiver: Seek emergency medical care immediately after use .
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Naloxone side effects
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Common side effects
- Withdrawal symptoms in people dependent on opioids (body aches, sweating, nausea, shaking)
- Vomiting
- Agitation
- Sleepiness
- Headache
- Dizziness
- Nasal discomfort (nasal spray)
- Abdominal pain
When to get medical help
- Call 911 right after the first dose. Naloxone can wear off before the opioid does, so breathing problems can return.
- Watch for severe opioid withdrawal in people dependent on opioids. In newborns it can be life-threatening (seizures, excessive crying).
- Heart problems have been reported after sudden reversal, including fast or irregular heartbeat, blood pressure changes, fluid in the lungs and cardiac arrest. Risk is higher with existing heart disease.
- Seek care for an allergic reaction to naloxone or any ingredient.
- If you are stuck by a used Zimhi needle, get medical attention right away.
Many effects come from the sudden reversal of opioids.
- Withdrawal symptoms in people dependent on opioids
- Vomiting
- Agitation
- Sleepiness
- Headache and dizziness
- Nasal discomfort (nasal spray)
- Abdominal pain
Seek help for returning breathing problems, severe withdrawal, or heart symptoms.
Naloxone warnings and precautions
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- Breathing problems can return after the first dose because naloxone may wear off before the opioid. Call 911 and keep watching the person.
- Severe withdrawal can occur in people dependent on opioids. In newborns it can be life-threatening.
- Sudden reversal can cause heart and lung problems, mostly in people with existing heart disease.
- Reversal of buprenorphine or pentazocine may be incomplete.
- Zimhi's needle stays exposed until the safety guard is deployed, so needlestick injury is possible.
Naloxone interactions
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The label highlights a few situations to be careful with.
- Buprenorphine and pentazocine: reversal may be incomplete, and larger or repeat doses may be needed.
- Medicines with heart effects: heart problems after reversal are more likely.
Interactions listed in the FDA-approved label
From the Naloxone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Drug Interactions Large doses of naloxone are required to antagonize buprenorphine since the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.
Read the label’s full interactions text
Drug Interactions Large doses of naloxone are required to antagonize buprenorphine since the latter has a long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor. Buprenorphine antagonism is characterized by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression. The barbiturate methohexital appears to block the acute onset of withdrawal symptoms induced by naloxone in opiate addicts.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Naloxone
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- Do not use if allergic to naloxone or any ingredient.
- Tell your prescriber about heart disease.
- Opioid dependence: withdrawal may be triggered suddenly.
- Pregnancy: naloxone crosses the placenta and may cause withdrawal in the fetus.
- Children: watch closely for at least 24 hours after a response.
- Breastfeeding: unlikely to affect the infant.
- Older adults: caution is advised because of reduced organ function or other medicines.
What Naloxone does in the body
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When given into a vein, naloxone usually starts working within two minutes. Onset is quicker by vein than by muscle or under the skin. How long it lasts depends on the dose and route.
How your body processes Naloxone
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Naloxone spreads through the body after injection and readily crosses the placenta. It binds only weakly to plasma proteins. In a study of Kloxxado, blood levels peaked in about 10 to 15 minutes after a nasal dose, with a half-life of roughly 1 to 3 hours. Nasal absorption was lower than injection into a vein or muscle.
How to store Naloxone
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and Shipping Store at controlled room temperature 15°C - 25°C (59°F - 77°F); excursions permitted between 4°C and 40°C (39°F and 104°F). Do not freeze. Protect from heat.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Naloxone: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Naloxone — the kind of thing our pharmacy team would talk through with you at the counter.
What is naloxone for?
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How do I use it in an emergency?
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Why do I still need to call 911 if they wake up?
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What side effects might the person have?
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Is it safe in pregnancy or for kids?
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Will it work for every opioid?
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Is Naloxone available over the counter?
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When was Naloxone first available?
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Who makes Naloxone?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Naloxone on HelloPharmacist
Naloxone forms and strengths (how it comes)
Naloxone is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Zimhi is for emergency treatment of known or suspected opioid overdose in adults and children.
- The naloxone hydrochloride auto-injector is for military personnel and chemical incident responders, for suspected high-potency opioid exposure in patients 12 and older, and for temporary prevention of breathing and nervous system depression when entering a contaminated area.
- Naloxone hydrochloride injection reverses opioid depression, helps diagnose suspected opioid overdose, and may help raise blood pressure in septic shock.
- Zimhi is for muscle or under-the-skin use only, into the outer thigh, through clothing if needed.
- Zimhi is meant to be given by people 12 or older. Seek emergency care right after use.
- Naloxone hydrochloride injection may be given into a vein, muscle or under the skin. The vein route works fastest.
- Naloxone hydrochloride injection: keep the patient under watch, since repeat doses may be needed.
Nasal spray
How this form is used
- Narcan Nasal Spray is for emergency treatment of known or suspected opioid overdose.
- Kloxxado is for emergency treatment of known or suspected opioid overdose in adults and children.
- Rextovy and Rezenopy are for emergency treatment of known or suspected opioid overdose in adults and children.
- Narcan Nasal Spray is for use in the nose only, one spray into one nostril.
- Kloxxado: give additional doses with a new spray every 2 to 3 minutes if needed until emergency help arrives.
- Rezenopy: if there is no response in 2 to 3 minutes, another dose may go into the other nostril with a new device.
- Rextovy: the device is ready to use. Do not prime or test it, and do not reuse it.
Nasal other
Naloxone on the U.S. market: products, makers and brands
How Naloxone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
75 companies list 202 Naloxone product records with the FDA, mostly as injection, nasal spray, nasal other; the earliest marketing or approval year on record is 1971. Brand names on the directory include Narcan, Kloxxado, Zimhi and 4 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Naloxone is used (Medicaid data)
A general measure of how commonly Naloxone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Naloxone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Naloxone prescribed? Of the 1,601 medications we measure, Naloxone ranks #179 by Medicaid prescriptions — more than 89% of them.
Utilization by Naloxone product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
naloxone hydrochloride 40 MG/ML Nasal Spray Most dispensed
Summed across the 10 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1725059
naloxone hydrochloride 80 MG/ML Nasal Spray
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2540703
1 ML naloxone hydrochloride 0.4 MG/ML Injection
Summed across the 7 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1659929
2 ML naloxone hydrochloride 1 MG/ML Prefilled Syringe
Summed across the 8 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191250
naloxone hydrochloride 16 MG/ML Nasal Spray
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2637879
naloxone hydrochloride 0.4 MG/ML Injectable Solution
Summed across the 1 of 27 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191222
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Naloxone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 28 of 162 listed Naloxone NDCs with Medicaid activity.
Compare Naloxone products
A representative set of FDA-listed product records for Naloxone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Akorn × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | AuroMedics Pharma LLC × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | AuroMedics Pharma LLC | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Baxter Healthcare Corporation × 4 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | BPI Labs LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | BPI Labs LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Dr. Reddy | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Dr. Reddy's Laboratories, Inc. × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Eugia US LLC × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Eugia US LLC × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Eugia US LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Eugia US LLC | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | General Injectables & Vaccines, Inc | ANDA | View NDC → |
| 1 mg/mL | Parenteral | General Injectables & Vaccines, Inc × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | General Injectables & Vaccines, Inc. × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | General Injectables and Vaccines, INC. × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | Henry Schein, Inc × 3 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Henry Schein, Inc. × 3 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Henry Schein, Inc. × 4 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | Henry Schein, Inc. × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co. LLC, DBA Health First | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co. LLC, DBA Health First × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co. LLC, DBA HealthFirst | ANDA | View NDC → |
| 1 mg/mL | Parenteral | HF Acquisition Co. LLC, DBA HealthFirst × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co. LLC. DBA HealthFirst | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst × 4 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | HF Acquisition Co LLC, DBA HealthFirst × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Hospira, Inc. × 3 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Hospira, Inc. × 5 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | International Medication Systems, Limited × 7 listings | ANDA | View NDC → |
| 10 mg/0.4 mL | Intramuscular, Subcutaneous | Kaleo, Inc. | NDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Lifestar Pharma LLC × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC × 5 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Medical Purchasing Solutions, LLC × 4 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | Medical Purchasing Solutions, LLC × 4 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Medical Purchasing Solutions, LLC | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Mylan Institutional LLC × 3 listings | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Mylan Institutional LLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular; Intravenous; Subcutaneous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | NorthStar RxLLC | ANDA | View NDC → |
| 1 mg/mL | Intramuscular, Intravenous, Subcutaneous | Par Health USA, LLC | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | ProPharma Distribution × 2 listings | ANDA | View NDC → |
| 1 mg/mL | Parenteral | Remedyrepack Inc. | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Sina Health Inc | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular, Intravenous, Subcutaneous | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
| 0.4 mg/mL | Intramuscular; Intravenous; Subcutaneous | Somerset Therapeutics, LLC × 3 listings | ANDA | View NDC → |
| 5 mg/0.5 mL | Intramuscular; Subcutaneous | Uswm, Llc | NDA | View NDC → |
| 5 mg/0.5 mL | Intramuscular, Subcutaneous | ZMI Pharma Inc. | NDA | View NDC → |
| 💊Nasal other | ||||
| 4 mg/0.1 mL | Nasal | A-S Medication Solutions × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 4 mg/0.1 mL | Nasal | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 4 mg/0.1 mL | Nasal | Sandoz Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 💊Nasal spray | ||||
| 4 mg/0.1 mL | Nasal | A-S Medication Solutions × 2 listings | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Advanced Rx of Tennessee, LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Amerisource Bergen | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Amneal Pharmaceuticals NY LLC × 2 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Asclemed USA, Inc. | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | AvKARE | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | BluePoint Laboratories | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | CVS Pharmacy, Inc | ANDA | View NDC → |
| 2 mg/0.1 mL | Nasal | Emergent Devices Inc. × 2 listings | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Emergent Devices Inc. × 6 listings | NDA | View NDC → |
| 3 mg/0.1 mL | Nasal | Harm Reduction Therapeutics, Inc. | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | HF Acquisition Co LLC, DBA HealthFirst × 3 listings | ANDA | View NDC → |
| 8 mg/0.1 mL | Nasal | Hikma Specialty USA Inc. × 2 listings | NDA | View NDC → |
| 4 mg/0.25 mL | Nasal | International Medication Systems, Ltd. | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Lake Erie Medical DBA Quality Care Products LLC | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Padagis Israel Pharmaceuticals Ltd × 4 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Proficient Rx LP | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Proficient Rx LP | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Quality Care Products, LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Redpharm Drug | ANDA | View NDC → |
| 10 mg/0.11 mL | Nasal | Scienture LLC | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Sportpharm LLC | NDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Sportpharm LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Strategic Sourcing Services LLC | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Teva Pharmaceuticals USA, Inc. × 2 listings | ANDA | View NDC → |
| 4 mg/0.1 mL | Nasal | Walgreen Co. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 g/g | — | Aspen Oss B.V. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Francopia × 3 listings | BULK INGREDIENT | View NDC → |
| 100 g/100 g | — | Macfarlan Smith Limited | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 g/g | — | Medisca Inc. | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Noramco, LLC | BULK INGREDIENT | View NDC → |
| 100 g/100 g | — | Pharmaron Manufacturing Services (UK) Ltd | BULK INGREDIENT | View NDC → |
| 100 g/100 g | — | Professional Compounding Centers of America | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 1 kg/kg | — | Saneca Pharmaceuticals a.s. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sanofi Winthrop Industrie × 3 listings | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Siegfried AG | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Siegfried PharmaChemikalien Minden Gmbh | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | SpecGx LLC × 2 listings | BULK INGREDIENT | View NDC → |
| 100 g/100 g | — | Spectrum Laboratory Products, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Sun Pharmaceutical Industries, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Veranova, L.P. | BULK INGREDIENT | View NDC → |
Showing 200 of 202 products — FDA National Drug Code Directory. See every product, package size and price: browse all 202 Naloxone NDCs →
Naloxone side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Naloxone — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Naloxone in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Naloxone FDA approval history
How Naloxone went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Naloxone recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Naloxone recalls since July 2021.
✅No Naloxone recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 7242 6 dose forms · 16 strengths
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Dose form (SCDF) Auto-Injector RxCUI 1659888In current FDA listingsClinical drug / strength (SCD) 0.4 ML naloxone hydrochloride 25 MG/MLRxCUI 25961750.4 ML naloxone hydrochloride 5 MG/MLRxCUI 1855730 -
Dose form (SCDF) Cartridge RxCUI 1659913No current FDA listingClinical drug / strength (SCD) 1 ML naloxone hydrochloride 0.4 MG/MLRxCUI 1191234 -
Dose form (SCDF) Injectable Solution RxCUI 372989In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.02 MG/MLRxCUI 1191212hydrochloride 0.4 MG/MLRxCUI 1191222hydrochloride 1 MG/MLRxCUI 1191228 -
Dose form (SCDF) Injection RxCUI 1659928In current FDA listingsClinical drug / strength (SCD) 1 ML naloxone hydrochloride 0.4 MG/MLRxCUI 1659929 -
Dose form (SCDF) Nasal Spray RxCUI 1725058In current FDA listingsClinical drug / strength (SCD) hydrochloride 16 MG/MLRxCUI 2637879hydrochloride 20 MG/MLRxCUI 1870933hydrochloride 30 MG/MLRxCUI 2673091hydrochloride 40 MG/MLRxCUI 1725059hydrochloride 80 MG/MLRxCUI 2540703hydrochloride 90.9 MG/MLRxCUI 2704891 -
Dose form (SCDF) Prefilled Syringe RxCUI 727348No current FDA listingClinical drug / strength (SCD) 0.5 ML naloxone hydrochloride 10 MG/MLRxCUI 25896121 ML naloxone hydrochloride 0.4 MG/MLRxCUI 26795042 ML naloxone hydrochloride 1 MG/MLRxCUI 1191250
Look up RxCUI 7242 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Naloxone supply and shortage status
Whether Naloxone is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Naloxone brand names
Naloxone is sold under 7 brand names in the FDA directory — Narcan, Kloxxado, Zimhi, Rextovy and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Naloxone: manufacturers and labelers
75 companies list Naloxone products with the FDA. By number of product records, the largest are HF Acquisition Co LLC, DBA HealthFirst, Medical Purchasing Solutions, LLC, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 51 more on the FDA NDC directory.
Naloxone drug class (RxNorm)
Naloxone belongs to the Opioid Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Naloxone page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. ZMI Pharma Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →