SprinJene
- Product NDC
- 63404-1108
- 11-digit product format
- 634041108
- Labeler code
- 63404
- Product ID
- 63404-1108_2c7c212f-b7da-47a0-bbfb-73fd530e252a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Monofluorophosphate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Health and Natural Beauty USA Corp
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-07-01
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63404-1108-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63404-1108-2 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63404-1108-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63404-1108-2 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63404-1108-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63404-1108-2 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63404-1108-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63404-1108-2 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63404-1108-2 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 63404-1108-1 | 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
- Health Boost
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9be87bcd-403a-4d7e-8ded-9833249565d1 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63404-1108-1 | 2025-01-30 | SprinJene ® Health Boost |
| 63404-1108-1 | 2025-01-30 | SprinJene ® SprinJene ® Health Boost Gel |
| 63404-1108-2 | 2025-01-30 | SprinJene ® Health Boost |
| 63404-1108-2 | 2025-01-30 | SprinJene ® SprinJene ® Health Boost Gel |
| 63404-1108-1 | 2023-02-22 | SprinJene ® Health Boost |
| 63404-1108-1 | 2023-02-22 | SprinJene ® SprinJene ® Health Boost Gel |
| 63404-1108-2 | 2023-02-22 | SprinJene ® Health Boost |
| 63404-1108-2 | 2023-02-22 | SprinJene ® SprinJene ® Health Boost Gel |
| 63404-1108-1 | 2020-01-31 | SprinJene ® Health Boost |
| 63404-1108-1 | 2020-01-31 | SprinJene ® SprinJene ® Health Boost Gel |
| 63404-1108-2 | 2020-01-31 | SprinJene ® Health Boost |
| 63404-1108-2 | 2020-01-31 | SprinJene ® SprinJene ® Health Boost Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63404-1108-1 | SprinJene Health Boost | 142 g in 1 TUBE | PASTE, DENTIFRICE | 142 | 3 | |
| 63404-1108-1 | SprinJene Health Boost | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 | |
| 63404-1108-2 | SprinJene Health Boost | 42 g in 1 TUBE | PASTE, DENTIFRICE | 42 | 3 | |
| 63404-1108-2 | SprinJene Health Boost | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63404-1108 | SPRINJENE HEALTH BOOST (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] | 3 | Current NDC, Legacy NDC, 4 package rows | 20230223_9be87bcd-403a-4d7e-8ded-9833249565d1.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 |
|---|---|---|---|---|---|---|
| Crest Pro Health Sensitive and Enamel Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb48b15c-f821-e5cd-e053-6294a90ac64c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Luminous Purple | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fbfcd837-4d88-5f82-e053-6394a90afbf6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health with a Touch of Scope | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb572b41-36cd-55d7-e053-6394a90a71c8 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Whitening Gel | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb5b1e94-bed6-8486-e053-6294a90a3a84 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Ultra Vivid Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | cba96ef0-0519-059f-e053-2a95a90a43ad | 2026-01-08 | Warnings | M021 |
| Crest 4in1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ce545406-3c4f-1ba7-e053-2a95a90a91ac | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d218ddc0-1d5f-f39b-e053-2995a90a96ed | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Antibacterial Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d58bc842-2687-e52d-e053-2995a90a5433 | 2026-01-08 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d65b3153-2026-a8c0-e053-2a95a90a31d6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Charcoal | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6f68485-b92f-41c7-e053-2995a90a4fe5 | 2026-01-08 | Warnings | M021 |
| KIDS Crest Advanced Enamel Plus Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d837ecde-249a-7868-e053-2a95a90a56ae | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Intensive Cleaning | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6fa4187-a651-647b-e053-2995a90a8567 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Gum Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7729dde-c828-34e6-e053-2a95a90a5ee6 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d811306f-4994-7a5a-e053-2995a90adf16 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d810d4e5-ba66-efe1-e053-2995a90abfc0 | 2026-01-08 | Warnings | M021 |
| Crest Braces Care Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d823cba4-c4cf-7d7a-e053-2995a90a01f0 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Sensitive Relief | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7730674-7513-52cf-e053-2995a90ab32c | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Flavor | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 26a7a892-5da4-4749-bbb6-566efab7d749 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi-Benefit Plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8c91095d-88c0-4d22-a79a-7d0f0d05302b | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Deep Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d774295f-8ebd-9877-e053-2a95a90a9a0e | 2026-01-08 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63404-1108-1 | 63404110801 | 1 TUBE in 1 CARTON (63404-1108-1) / 142 g in 1 TUBE | 1 tube | 2016-07-01 | No | No | Current |
| 63404-1108-2 | 63404110802 | 1 TUBE in 1 CARTON (63404-1108-2) / 42 g in 1 TUBE | 1 tube | 2016-07-01 | No | No | Current |