SprinJene
- Product NDC
- 63404-0720
- Requested package NDC
- 63404-0720-2
- 11-digit product format
- 634040720
- Labeler code
- 63404
- Product ID
- 63404-0720_6a6f35e1-8954-4348-842c-1b9bcc500228
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ALCOHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Health and Natural Beauty USA Corp
- Application
- M003
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-08-01
- Substance
- ALCOHOL
- Active strength
- 70 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SprinJene
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALCOHOL | 70 mL/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3K9958V90M | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 581662 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1853f023-f4db-4cd8-a4df-a439bc306cc3 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63404-0720-1 | SprinJene | 500 mL in 1 BOTTLE, PUMP | GEL | 500 | 1 | |
| 63404-0720-2 | SprinJene | 300 mL in 1 BOTTLE, PUMP | GEL | 300 | 1 | |
| 63404-0720-3 | SprinJene | 250 mL in 1 BOTTLE, PUMP | GEL | 250 | 1 | |
| 63404-0720-4 | SprinJene | 80 mL in 1 BOTTLE, PUMP | GEL | 80 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63404-0720 | SPRINJENE (ALCOHOL) GEL [HEALTH AND NATURAL BEAUTY USA CORP] | 1 | Current NDC, Legacy NDC, 4 package rows | 20200801_1853f023-f4db-4cd8-a4df-a439bc306cc3.zip |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 70% | ISOPROPYL ALCOHOL | United Natural Foods, Inc. dba UNFI | d39bc652-442d-4d91-9eba-a496636b9533 | 2026-02-26 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | United Natural Foods, Inc. dba UNFI | f6be70d5-763c-42d8-9b4e-a55e84c74785 | 2026-02-26 | Warnings, Adverse reactions | M003 |
| Rubbing | ETHYL ALCOHOL | United Natural Foods, Inc. dba UNFI | cd03611f-879a-4888-8d45-f8bdfd82529c | 2026-02-26 | Warnings, Adverse reactions | M003 |
| Lightning X POVIDONE IODINE WIPE | POVIDONE IODINE WIPE | Changzhou Maokang Medical Products Co., Ltd. | 04be4c2f-742b-7058-e063-6394a90a460d | 2026-02-25 | Warnings | M003 |
| 70% Isopropyl Rubbing Alcohol | ISOPROPYL RUBBING ALCOHOL | Better Living Brands, LLC | 4817df03-05a2-4e85-bec2-a06f9d57d0b8 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Better Living Brands, LLC | 4031ea5d-cba4-44f5-9a81-0cab2367d97e | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Better Living Brands, LLC | 1b2decdf-58be-4ab9-a481-6c78bd91faf0 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | Better Living Brands, LLC | 6391432a-a5b8-4528-88a6-862bc2062f68 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Family Dollar Stores, Inc | 58157bc5-54ea-49f8-9f17-f0eeb5732395 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Isopropyl | ISOPROPYL ALCOHOL | H E B | 25fea857-9ed8-49e7-b892-b24f639f83ca | 2026-02-24 | Warnings, Adverse reactions | M003 |
| 70% | ISOPROPYL ALCOHOL | H E B | 403e52e8-bac1-460a-81ef-bac5a7b5de10 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | H E B | 28cd16f5-61c5-4943-9dd6-a9864fa35806 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| 50% Isopropyl Alcohol | ISOPROPYL ALCOHOL | H E B | 0ed762dd-9432-45b4-9e75-c24fb28ff956 | 2026-02-24 | Warnings, Adverse reactions | M003 |
| Sunvine 70 Isopropyl Alcohol First Aid Antiseptic | ISOPROPYL ALCOHOL | Mac Innovations, LLC | 8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c76 | 2026-02-24 | Warnings | M003 |
| Alcohol Prep Pads | ISOPROPYL ALCOHOL | ALCOVE BRANDS | 4bad1fee-b4fe-c518-e063-6294a90a0318 | 2026-02-24 | Warnings | M003 |
| First Aid Antiseptic | POVIDONE-IODINE | Better Living Brands, LLC | 3ce6e6af-b513-ed9f-e063-6394a90a4ce7 | 2026-02-23 | Warnings, Adverse reactions | M003 |
| Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy Pear | ALCOHOL | Scent Theory Products LLC | 4b865d82-71c3-1023-e063-6294a90ac774 | 2026-02-23 | Warnings | M003 |
| Hydrogen Peroxide 3% | HYDROGEN PEROXIDE 3% | 4 Visions LLC | 4b87254a-8dc5-3873-e063-6394a90a3f3b | 2026-02-23 | Warnings | M003 |
| Isopropyl Rubbing Alcohol | ISOPROPYL ALCOHOL | 4 Visions LLC | 4b87d4cc-163e-1432-e063-6294a90af483 | 2026-02-23 | Warnings | M003 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | 4 Visions LLC | 4b88008f-fe78-4b7e-e063-6294a90ab9ae | 2026-02-23 | Warnings | M003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 581662 | ethanol 70 % Topical Gel | PSN | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 1 |
| 581662 | ethanol 0.7 ML/ML Topical Gel | SCD | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 1 |
| 581662 | ethanol 70 % Topical Gel | SY | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 1 |
| 581662 | ethyl alcohol 70 % Topical Gel | SY | 1853f023-f4db-4cd8-a4df-a439bc306cc3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63404-0720-2 | 63404072002 | 300 mL in 1 BOTTLE, PUMP (63404-0720-2) | 300 ml | 2020-08-01 | 0000-00-00 | No | No | Current |