Naloxone Hydrochloride 4 mg/.1mL Spray, Metered
by 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
NDC 00591-3871-99
🏷️ FDA NDC (as labeled)
0591-3871-99
billing pads the labeler segment with a zero
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
0591-3871-99
Product NDC
0591-3871
11-digit billing NDC
00591387199
NCPDP billing unit
EA — each (per item)
RxCUI
1725059
UNII
F850569PQR
Application #
ANDA209522
SPL Set ID
49350f7e-d613-40a8-8941-a2ec30eafdf3
Established class (EPC)
Opioid Antagonist
Mechanism of action
Opioid Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-01-17
Route
NASAL
Dosage form
SPRAY, METERED
Substance
NALOXONE HYDROCHLORIDE
GCN Seq No
075222
GCN
40233
HICL code
001874
Ingredient (HICL)
Naloxone Hcl
HIC1 code
H
Therapeutic class — broad (HIC1)
Nervous System (Except Autonomic)
HIC2 code
H3
Therapeutic class — intermediate (HIC2)
Analgesics
HIC3 code
H3T
Therapeutic class — specific (HIC3)
Opioid Antagonists
AHFS code
28:10.00.00
AHFS class
Opioid Antagonists (28:10)
FDB label name
NALOXONE HCL 4 MG NASAL SPRAY
FDB brand name
Naloxone Hcl
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0591-3871-99 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00591-3871-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Opioid Antagonist class.
Pharmacologic class
Opioid Antagonist
Drug family (ATC)
Other opioids, Natural opium alkaloids, Benzomorphan derivatives
How it works
Opioid Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerActavis Pharma, Inc.
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA209522 (ANDA)
Labeler code00591
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio324 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name NALOXONE HCL 4 MG NASAL SPRAY Ingredient Naloxone Hcl
📖 What it is MedlinePlus · NLM
Prescription and nonprescription (over the counter) naloxone nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose in adults and children. Naloxone nasal spray is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- Naloxone is an emergency medicine that rapidly reverses the effects of an opioid overdose — things like very slow or stopped breathing, extreme drowsiness, or unconsciousness. You...
- What exactly does naloxone do, and when should I use it?
- Give one spray into one nostril. The device is ready to use — no assembly needed for most products like Narcan or Kloxxado. If the person doesn't improve within 2 to 3 minutes, giv...
- How do I actually use the nasal spray, and what if it doesn't seem to work?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Naloxone Hydrochloride — tap one for details:
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Naloxone Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Narcan 4 mg/.1mL 69547-0627-02 | Emergent | 2 vials | $16.680 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 00480-3478-68 | Teva | 1 vial | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 45802-0578-84 | Padagis | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 46122-0812-71 | AMERISOURCE | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 60219-2104-07 | Amneal | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 68001-0645-45 | BluePoint | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 69238-2104-07 | Amneal | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 70677-1283-01 | Strategic | 2 vials | $16.922 | — | Availability likely | — |
| Naloxone Hydrochloride 4 mg/.1mL 00093-2165-68 | Teva | 1 vial | $34.270 | — | Discontinued | — |
| Narcan 4 mg/.1mL 69547-0353-02 | Emergent | 2 vials | $59.869 | — | Discontinued | — |
| Naloxone Hydrochloride 4 mg/.1mL 00363-2140-02 | Walgreen | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mLthis 00591-3871-99 | Actavis | 1 vial | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 42291-0493-02 | AvKARE | 2 vials | — | — | FDA listed | — |
| Narcan 4 mg/.1mL 50090-2422-00 | A-S | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 50090-5908-00 | A-S | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 50090-6710-00 | A-S | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 50090-6963-00 | A-S | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 51316-0210-02 | CVS | 2 vials | — | — | FDA listed | — |
| Narcan Naloxone Hci 4 mg/.1mL 51662-1240-01 | HF | 1 ml | — | — | FDA listed | — |
| NALOXONE HCl 4 mg/.1mL 51662-1620-01 | HF | 1 ml | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 51662-1659-02 | HF | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 67296-1928-02 | Redpharm | 1 vial | — | — | Discontinued | — |
| Narcan 4 mg/.1mL 71205-0528-02 | Proficient | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 71205-0707-02 | Proficient | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 72162-2376-02 | Bryant | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 76420-0867-02 | Asclemed | 1 vial | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 80425-0409-01 | Advanced | 2 vials | — | — | FDA listed | — |
| Narcan 4 mg/.1mL 85766-0076-02 | Sportpharm | 2 vials | — | — | FDA listed | — |
| Naloxone Hydrochloride 4 mg/.1mL 85766-0228-02 | Sportpharm | 1 vial | — | — | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00591-3871-99 You're viewing this | 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 | 2025-01-17 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0591-3871-99, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00591-3871-99, written without dashes as 00591387199. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00591-3871-99, the first segment (00591) is the labeler code FDA assigned to Actavis Pharma, Inc.; the middle segment (3871) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Actavis Pharma, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Actavis Pharma, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin this medicine can save a life
⏱️ Dosage and Administration ▾
Directions 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 ▾
Warning 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 ▾
Active ingredient (in each spray) Naloxone hydrochloride 4 mg
🧪 Inactive Ingredients ▾
Inactive ingredients benzalkonium chloride, edetate disodium, sodium chloride buffered with sodium hydroxide/hydrochloric acid, water
🎯 Purpose ▾
Purpose Emergency treatment of opioid overdose
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.