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Naloxone Hydrochloride
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Naloxone Hydrochloride | 4 mg/.1mL | 1191250 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Opioid Antagonist [EPC] | EPC | All 19 members |
| Opioid Antagonists [MoA] | MoA | All 19 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 209522-001 | NALOXONE HYDROCHLORIDE | SPRAY, METERED | NALOXONE HYDROCHLORIDE | Over-the-counter | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 12 | Labeling | Approved | June 28, 2024 | Standard |
| Supplement | 4 | Labeling | Approved | April 5, 2021 | Standard |
| Supplement | 2 | Labeling | Approved | April 5, 2021 | Standard |
| Original application | 1 | Approved | April 19, 2019 | Standard |
Review documents
- 0 · Original application · May 22, 2019
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240130). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
Purpose
openFDA Drug LabelingPurpose Emergency treatment of opioid overdose
Dosage and Administration
openFDA Drug LabelingDirections Step 1: CHECK if you suspect an overdose: CHECK for a suspected overdose: the person will not wake up or is very sleepy or not breathing well yell “Wake up!” shake the person gently if the person is not awake, go to Step 2 Step 2: GIVE 1 st dose in the nose HOLD the nasal spray device with your thumb on the bottom of the plunger INSERT the nozzle into either NOSTRIL PRESS the plunger firmly to give the 1 st dose 1 nasal spray device contains 1 dose Step 3: CALL CALL 911 immediately after giving the 1 st dose Step 4: WATCH & GIVE WAIT 2-3 minutes after the 1 st dose to give the medicine time to work if the person wakes up: Go to Step 5 if the person does not wake up: CONTINUE TO GIVE doses every 2-3 minutes until the person wakes up it is safe to keep giving doses Step 5: STAY STAY until ambulance arrives: even if the person wakes up GIVE another dose if the person becomes very sleepy again You may need to give all the doses in the pack step 1 step 2 step 3 step 4 step 5
Warnings
openFDA Drug LabelingWarning When using this product some people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each spray) Naloxone hydrochloride 4 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NALOXONE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 0591-3871-99 | 0591-3871 | Actavis Pharma, Inc. | 2 BLISTER PACK in 1 CARTON (0591-3871-99) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0591-3871-54) / .1 mL in 1 VIAL, SINGLE-DOSE | January 17, 2025 |
| 76420-867-02 | 76420-867 | Asclemed USA, Inc. | 2 BLISTER PACK in 1 CARTON (76420-867-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE | October 29, 2024 |
| 85766-228-02 | 85766-228 | Sportpharm LLC | 2 BLISTER PACK in 1 CARTON (85766-228-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE | July 2, 2026 |
| 0480-3478-68 | 0480-3478 | Teva Pharmaceuticals, Inc. | 2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE | September 23, 2024 |
| 0591-3871 | 0591-3871 | Actavis Pharma, Inc. | — | January 17, 2025 |
| 76420-867 | 76420-867 | Asclemed USA, Inc. | — | September 23, 2024 |
| 85766-228 | 85766-228 | Sportpharm LLC | — | September 23, 2024 |
| 0480-3478 | 0480-3478 | Teva Pharmaceuticals, Inc. | — | September 23, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.