FDA.reportPublic FDA data

Naloxone Hydrochloride Nasal Spray

Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2026-08-25
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-08-28 00:01:53

Label at a glance#

ProductNaloxone Hydrochloride
Active ingredientNALOXONE HYDROCHLORIDE
Label structure10 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 medications or 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 check
1 check

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
2 give
2 give

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
3 call
3 call

Step 3: CALL 911

  • CALL 911 immediately after giving the 1st dose
step 4
step 4

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
5 stay
5 stay

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

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

Questions or comments?

OTC - QUESTIONS SECTION

1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

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
hand
hand

Drug Facts

Active ingredient (in each spray) Purpose

Naloxone hydrochloride 4 mg .............................................................................................................................. Emergency treatment

of opioid overdose

Uses

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

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
2 give
2 give

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
3 call
3 call

Step 3: CALL 911

  • CALL 911 immediately after giving the 1st dose
step 4
step 4

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
5 stay
5 stay

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

 

 

Warnings

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.

Other information

  • 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

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

Questions or comments?

1-877-835-5472 (Mon-Fri, 9AM-5PM EST)

For opioid emergencies, call 911.For questions or more information about Naloxone Hydrochloride Nasal Spray, contact Amneal Pharmaceuticals at 1-877-835-5472.

Rev. 11-2025-05


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369238210477GTIN-13: 0369238210477
EAN-13: 0369238210477
GTIN-12: 369238210477
UPC-A: 369238210477
GTIN storage (14 digits): 00369238210477		naloxone-hydrochloride-nasal-spray-12.jpg
QR code linkQR Codedocuments.amneal.com/pi/naloxone-IFU.mp4naloxone-hydrochloride-nasal-spray-12.jpg

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
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
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
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2104-1EA - Each69238-210491ff8fe2-0e79-477f-b698-28929742cf6512024-05-16
69238-2104-7EA - Each69238-210406b3edfc-7c4e-46db-a6cc-917639d8c9bf12024-05-16

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
69238-210469238-2104-1, 69238-2104-7

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
NALOXONE HYDROCHLORIDEF850569PQRACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-12-09full-release2026-06-01 01:49:10
102025-12-09monthly-update2026-06-03 17:52:36
92025-08-05full-release2026-06-01 01:09:22

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 44.

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
2026-10-15 13:18:302026-09A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23c2088c7a36db…
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 HYDROCHLORIDEAmneal Pharmaceuticals LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2026-08-25WarningsExact identifier
ndc (package): 69238-2104-1
ndc (package): 69238-2104-7
ndc (product): 69238-2104
ndc11 (package): 69238210401
ndc11 (package): 69238210407
spl id: 38da0633-039b-450a-9b04-592db2238396
spl set id: 8091a73d-9ecd-4578-a57b-5d85a2c5a16a

Reported adverse events (FAERS/openFDA)#

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