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
• to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin • this medicine can save a life
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...
Naloxone hydrochloride 3 mg
Emergency treatment of opioid overdose
Step 1: CHECK if you suspect an overdose
| |
Step 2: GIVE 1st dose in the nose
| |
Step 3: CALL 911
| |
Step 4: WATCH & GIVE
| |
Step 5: STAY
|
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.
hydrochloric acid, purified water, sodium chloride, sodium hydroxide, trisodium citrate dihydrate
for more information call toll-free (888)-412-7454 or go to
www.RiVive.com
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
Label
| Class | Version | Type | Effective |
|---|---|---|---|
| NALOXONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82954-0100-1 | RiVive | 2 in 1 CARTON | SPRAY | 2 | 2 | |
| 82954-0100-1 | RiVive | 0.1 mL in 1 VIAL, SINGLE-DOSE | SPRAY | 0.1 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 82954-0100-1 | EA - Each | 82954-0100 | 7ae409eb-0555-4293-8b7a-ba39bfb681d0 | 1 | 2024-04-05 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 82954-0100 | 82954-0100-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NALOXONE HYDROCHLORIDE | F850569PQR | ACTIB |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217722-001 | RIVIVE | NALOXONE HYDROCHLORIDE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 |
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | |
| N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | |
| N217722-001 | 12458591 | 2032-05-11 | U-3671 | 2025-11-26 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | 9b2671bbb829… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217722-001 | RIVIVE | 3MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-07-28 | a50c72e98297… |
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N217722-001 | 12458591 | 2032-05-11 | U-3671 | 2025-11-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N217722-001 | 12458591 | 2032-05-11 | U-3671 | 2025-11-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N217722-001 | 12458591 | 2032-05-11 | U-3671 | 2025-11-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N217722-001 | 12458591 | 2032-05-11 | U-3671 | 2025-11-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N217722-001 | 11020343 | 2032-05-11 | U-3671 | 2023-08-25 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N217722-001 | 11806428 | 2032-05-11 | Drug product | 2024-01-25 | 1c564ffb4f44… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| RiVive | NALOXONE HYDROCHLORIDE | Harm Reduction Therapeutics, Inc. | 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d | 2026-01-13 | Warnings | 82954-0100-1 82954-0100 82954010001 4e308ade-33a2-4daa-acdd-af1559b90c17 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d |
Adverse event summaries are temporarily unavailable. Other product information remains available.