RiVive ® Naloxone HCl Nasal Spray 3 mg Emergency Treatment of Opioid Overdose

Manufacturer
Harm Reduction Therapeutics, Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:00

Label at a glance#

ProductRiVive
Active ingredientNALOXONE HYDROCHLORIDE
Label structure9 sections

Indications and 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

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 nasal spray device with thumb on plunger and a finger on each side of the nozzle • Insert nozzle into one nostril and press plunger firmly • Eac...

Label contents#

Full prescribing information#

Active ingredient (in each spray)

OTC - ACTIVE INGREDIENT SECTION

Naloxone hydrochloride 3 mg

Purpose

OTC - PURPOSE SECTION

Emergency treatment of opioid overdose

Uses

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

Directions

DOSAGE & ADMINISTRATION SECTION

Step 1Step 1

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 2Step 2

Step 2: GIVE 1st dose in the nose

  • Hold nasal spray device with thumb on plunger and a finger on each side of the nozzle
  • Insert nozzle into one nostril and press plunger firmly
  • Each nasal spray device contains only one dose of naloxone
Step 3Step 3

Step 3: CALL 911

  • Get medical help immediately after giving the first dose
  • Call 911 now
Step 4Step 4

Step 4: WATCH & GIVE

  • WAIT 2-3 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:

    • Give a second dose of medicine using a new nasal   spray device

    • It is safe to keep giving doses every 2-3 minutes until   the person wakes up

Step 5Step 5

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

Warning

WARNINGS SECTION

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

OTHER SAFETY INFORMATION

  • store at 20ºC to 25ºC (68ºF to 77ºF)
  • do not refrigerate
  • avoid excessive heat above 40ºC (104ºF)
  • do not use if sealed blister package is torn or opened

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrochloric acid, purified water, sodium chloride, sodium hydroxide, trisodium citrate dihydrate

Questions?

OTC - QUESTIONS SECTION

for more information call toll-free (888)-412-7454 or go to www.RiVive.com

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RiVive®
Naloxone HCl Nasal Spray 3 mg
 
Emergency Treatment
of Opioid Overdose

 
FOR USE IN
THE NOSE ONLY
NOZZLE
PLUNGER
EASY
TO USE
 
2-Single-Dose
Nasal Spray Devices

0.003 fl oz (0.1 mL) each
 

HARM REDUCTION
THERAPEUTICS
Distributed by Harm Reduction Therapeutics, Inc.
Bethesda, MD 20814

image-01image-01
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2673091naloxone HCl 3 MG in 0.1 ML Nasal SprayPSN2
2673091naloxone hydrochloride 30 MG/ML Nasal SpraySCD2
2673091naloxone hydrochloride 3 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
82954-0100-1RiVive2 in 1 CARTONSPRAY22
82954-0100-1RiVive0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82954-0100-1EA - Each82954-01007ae409eb-0555-4293-8b7a-ba39bfb681d012024-04-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82954-010082954-0100-1

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
N217722-001RIVIVENALOXONE HYDROCHLORIDE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N217722-001110203432032-05-11U-36712023-08-25
N217722-001118064282032-05-11Drug product2024-01-25
N217722-001124585912032-05-11U-36712025-11-26

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 22:38:342026-08N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-2884e616aacf4f…
2026-08-18 06:07:402026-07N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-289b2671bbb829…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N217722-001RIVIVE3MG/SPRAYSPRAY, METERED / NASALRLD, RS2023-07-28a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N217722-001110203432032-05-11U-36712023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08N217722-001118064282032-05-11Drug product2024-01-2584e616aacf4f…
2026-09-14 22:38:342026-08N217722-001124585912032-05-11U-36712025-11-2684e616aacf4f…
2026-08-18 06:07:402026-07N217722-001110203432032-05-11U-36712023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217722-001118064282032-05-11Drug product2024-01-25caaa826d4ba7…
2026-08-18 06:07:402026-07N217722-001124585912032-05-11U-36712025-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N217722-001110203432032-05-11U-36712023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217722-001118064282032-05-11Drug product2024-01-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N217722-001124585912032-05-11U-36712025-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217722-001110203432032-05-11U-36712023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217722-001118064282032-05-11Drug product2024-01-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N217722-001124585912032-05-11U-36712025-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N217722-001110203432032-05-11U-36712023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N217722-001118064282032-05-11Drug product2024-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217722-001110203432032-05-11U-36712023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N217722-001118064282032-05-11Drug product2024-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217722-001110203432032-05-11U-36712023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N217722-001118064282032-05-11Drug product2024-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217722-001110203432032-05-11U-36712023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N217722-001118064282032-05-11Drug product2024-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217722-001110203432032-05-11U-36712023-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N217722-001118064282032-05-11Drug product2024-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217722-001110203432032-05-11U-36712023-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N217722-001118064282032-05-11Drug product2024-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217722-001110203432032-05-11U-36712023-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N217722-001118064282032-05-11Drug product2024-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N217722-001110203432032-05-11U-36712023-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N217722-001118064282032-05-11Drug product2024-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217722-001110203432032-05-11U-36712023-08-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N217722-001118064282032-05-11Drug product2024-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217722-001110203432032-05-11U-36712023-08-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N217722-001118064282032-05-11Drug product2024-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217722-001110203432032-05-11U-36712023-08-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N217722-001118064282032-05-11Drug product2024-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N217722-001110203432032-05-11U-36712023-08-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05N217722-001118064282032-05-11Drug product2024-01-258072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217722-001110203432032-05-11U-36712023-08-256a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N217722-001118064282032-05-11Drug product2024-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N217722-001110203432032-05-11U-36712023-08-251c564ffb4f44…
2024-02-18 07:12 UTC2024-02N217722-001118064282032-05-11Drug product2024-01-251c564ffb4f44…

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
RiViveNALOXONE HYDROCHLORIDEHarm Reduction Therapeutics, Inc.1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d2026-01-13WarningsExact identifier
ndc (package): 82954-0100-1
ndc (product): 82954-0100
ndc11 (package): 82954010001
spl id: 4e308ade-33a2-4daa-acdd-af1559b90c17
spl set id: 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d

Reported adverse events (FAERS/openFDA)#

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