Naloxone Hydrochloride Nasal Spray

Manufacturer
AvKARE
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:59

Label at a glance#

ProductNaloxone Hydrochloride
Active ingredientNALOXONE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

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 1st 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 1st dose 1 n...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Naloxone hydrochloride 4 mg

Purpose

OTC - PURPOSE SECTION

Emergency treatment of opioid overdose

Use(s)

INDICATIONS & USAGE SECTION

  • to “revive” someone during an overdose from many  prescription pain medicationsor street drugs such as heroin
  • this medicine can save a life

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

some people may experience symptoms when they wake up, such as shaking, sweating, nausea, or feeling angry. This is to be expected.

Directions

DOSAGE & ADMINISTRATION SECTION

1 check1 check

Step 1: CHECK if you suspect an overdose

  • CHECKfor 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

2 give2 give

Step 2: GIVE 1st dose in the nose

  • HOLDthe nasal spray device with your thumb on the bottom of the plunger
  • INSERTthe nozzle into either NOSTRIL
  • PRESSthe plunger firmly to give the 1st dose
  • 1 nasal spray device contains 1 dose

3 call3 call

Step 3: CALL 911

  • CALL 911immediately after giving the 1st dose

step 4step 4

Step 4: WATCH & GIVE

  • WAIT2 to 3 minutes after the 1st 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 GIVEdoses every 2 to 3 minutes until the person wakes up
  • it is safe to keep giving doses

5 stay5 stay

Step 5: STAY

  • STAYuntil ambulance arrives: even if the person wakes up
  • GIVEanother dose if the person becomes very sleepy again
  • You may need to give all the doses in the pack

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature or refrigerated, between 2°C to 25°C (36°F to 77°F)
  • do not freeze
  • avoid excessive heat above 40°C (104°F)
  • protect from light
  • this product is packaged in individually-sealed blisters. Do not use if the blister is open or torn, or if the device appears damaged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, disodium ethylenediaminetetraacetate, hydrochloric acid, purified water, and sodium chloride

DIRECTIONS

SPL PATIENT PACKAGE INSERT SECTION

Naloxone Hydrochloride Nasal Spray, 4 mg

Emergency Treatment of Opioid Overdose

Important:

  • For use in the nose only
  • Do not test nasal spray device before use
  • 1 nasal spray device contains 1 dose of medicine
  • Each device sprays 1 time only

handhand

11

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

11

Step 2: GIVE 1st 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 1st dose
  • 1 nasal spray device contains 1 dose

11

Step 3: CALL 911

  • CALL 911 immediately after giving the 1st dose

11

Step 4: WATCH & GIVE

  • WAIT 2 to 3 minutes after the 1st 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 to 3 minutes until the person wakes up
  • it is safe to keep giving doses

11

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

For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact

AvKARE at 1-855-361-3993.

Mfg. Rev. 03-2023-01 AV 05/23

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

xx

xxxx

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN2
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD2
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NALOXONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-493-01Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12
42291-493-02Naloxone Hydrochloride2 in 1 CARTONSPRAY22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-493-01EA - Each42291-4930ded3426-e087-4e00-b429-4fb9596b5bc412024-06-10
42291-493-02EA - Each42291-4931dc1c004-af28-41ee-8a4b-3bd7b5b520c512024-06-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42291-49342291-493-01, 42291-493-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217992-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2384e616aacf4f…
2026-08-18 06:07:402026-07A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-238072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
ndc (package): 42291-493-02
ndc (package): 42291-493-01
ndc (product): 42291-493
ndc11 (package): 42291049301
ndc11 (package): 42291049302
spl id: 485f83f8-8404-eae8-e063-6294a90a3c33
spl set id: 1766a7f1-d301-945f-e063-6294a90ac6f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.