SprinJene
- Product NDC
- 63404-0910
- Requested package NDC
- 63404-0910-2
- 11-digit product format
- 634040910
- Labeler code
- 63404
- Product ID
- 63404-0910_8a4e6021-6529-4cfd-ab1a-0f756a9be87b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Health and Natural Beauty USA Corp
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-10
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.5 mg/g
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- Brand name suffix
- Fresh Boost
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 891775 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63404-0910-1 | 2025-01-30 | SprinJene™ Fresh Boost |
| 63404-0910-1 | 2025-01-30 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2025-01-30 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2025-01-30 | SprinJene™ Fresh Boost |
| 63404-0910-1 | 2023-02-22 | SprinJene™ Fresh Boost |
| 63404-0910-1 | 2023-02-22 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2023-02-22 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2023-02-22 | SprinJene™ Fresh Boost |
| 63404-0910-1 | 2020-01-31 | SprinJene™ Fresh Boost |
| 63404-0910-1 | 2020-01-31 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2020-01-31 | SprinJene™ Fresh Boost |
| 63404-0910-2 | 2020-01-31 | SprinJene™ Fresh Boost |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63404-0910-1 | SprinJene Fresh Boost | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | 3 | |
| 63404-0910-1 | SprinJene Fresh Boost | 130 g in 1 TUBE | GEL, DENTIFRICE | 130 | 3 | |
| 63404-0910-2 | SprinJene Fresh Boost | 42 g in 1 TUBE | GEL, DENTIFRICE | 42 | 3 | |
| 63404-0910-2 | SprinJene Fresh Boost | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63404-0910 | SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230223_919f6f51-6c43-4f1c-9bc7-029bf76c0e68.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 |
|---|---|---|---|---|---|---|
| COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT | SODIUM FLUORIDE | Colgate-Palmolive Company | b1ef8277-9919-453c-9d21-da4666d952de | 2026-09-17 | Warnings | M021 |
| TheraBreath | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 53c1086d-264b-9d00-e063-6394a90ad19d | 2026-09-09 | Warnings | M021 |
| Opalescence Whitening Cool Mint | SODIUM FLUORIDE | Ultradent Products, Inc. | 44e7d0ed-3c37-5889-e063-6294a90afcca | 2026-09-09 | Warnings | M021 |
| Opalescence Whitening | SODIUM FLUORIDE | Ultradent Products, Inc | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 2026-09-09 | Warnings | M021 |
| Opal by Opalescence Original | SODIUM FLUORIDE | Ultradent Products, Inc. | 5c3bf8fc-2e8f-4a58-bcbf-e47540072a49 | 2026-09-09 | Warnings | M021 |
| Opal by Opalescence Complete | OPAL BY OPALESCENCE COMPLETE | Ultradent Products, Inc. | 249cc46a-dad6-0345-e063-6394a90a4447 | 2026-09-09 | Warnings | M021 |
| Colgate MaxFresh Knockout | SODIUM FLUORIDE | Colgate-Palmolive Company | 0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9 | 2026-09-09 | Warnings | M021 |
| Colgate MaxFresh Charcoal | SODIUM FLUORIDE | Colgate-Palmolive Company | de3674f4-3ce6-47d5-8391-6ad6789d68d9 | 2026-09-09 | Warnings | M021 |
| Freshmint Premium Anticavity | SODIUM FLUORIDE | New World Imports, Inc | ef108fff-a79c-4e8d-8bf0-3fe567f93eb8 | 2026-09-08 | Warnings | M021 |
| Freshmint Premium Anticavity | SODIUM FLUORIDE | New World Imports, Inc | 1a42cf2d-6c48-4e38-97bc-b6f2084bf39b | 2026-09-08 | Warnings | M021 |
| Freshmint Premium Anticavity Gel | SODIUM FLUORIDE | New World Imports, Inc | dfe564c1-2097-431d-93f0-cf423f254248 | 2026-09-08 | Warnings | M021 |
| Freshmint Anticavity Fluoride | SODIUM MONOFLUOROPHOSPHATE | New World Imports, Inc | 5aff7e41-58cd-5ab8-e063-6294a90aa1c7 | 2026-09-08 | Warnings | M021 |
| Colgate Optic White Advanced Sparkling White | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | bc56603d-4190-48c1-b16e-3179a650cb39 | 2026-09-06 | Warnings | M021 |
| Dentalclean Advanced Pro | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 4d261dc8-b065-567f-e063-6294a90aa93f | 2026-09-04 | Warnings | M021 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA Attitude | 54bd43c9-489d-4e6b-9031-90ec0e3c4516 | 2026-09-01 | Warnings | M021 |
| BIO SPECTRA ATTITUDE | SODIUM FLUORIDE | 9055-7588 Qubec Inc. DBA Attitude | 53c344e9-49f5-48aa-8309-1e15f80b80a0 | 2026-09-01 | Warnings | M021 |
| Unpaste | ZERO WASTE FLUORIDE MINT TOOTH TABS | Avespan LLC | 312ae88d-7ea4-b3e0-e063-6294a90a99e5 | 2026-09-01 | Warnings | M021 |
| Dentalclean Regenerator Sensitive Dental Gel with Fluoride | SODIUM FLUORIDE 0.24% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 176aa3ed-e2a4-536d-e063-6294a90aa097 | 2026-08-31 | Warnings | M021 |
| Listerine Total Care Fresh Mint Anticavity | SODIUM FLUORIDE | Kenvue Brands LLC | b2ce66c3-dc48-47a5-a731-5550bc194679 | 2026-08-28 | Warnings | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Your Military Exchanges | cef74e9c-d3b5-4e92-9908-187be97b63ab | 2026-08-28 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 891775 | sodium fluoride 0.243 % Toothpaste | PSN | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
| 891775 | sodium fluoride 0.00243 MG/MG Toothpaste | SCD | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste | SY | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste | SY | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste | SY | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
| 891775 | sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste | SY | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63404-0910-2 | 63404091002 | 1 TUBE in 1 CARTON (63404-0910-2) / 42 g in 1 TUBE | 1 tube | 2014-10-10 | No | No | Current |