SprinJene
- Product NDC
- 63404-0201
- 11-digit product format
- 634040201
- Labeler code
- 63404
- Product ID
- 63404-0201_d02d031a-f428-4114-b5f3-8a518ffc08cf
- 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
- 2017-02-01
- 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 63404-0201-1 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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 | 63404-0201-1 | 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
- Natural
- 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 |
|---|---|
| e64cecc3-0845-4bdf-a449-d78248791ccf | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63404-0201-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1f23-f424-e053-dadaa90a57ce | SprinJene ® Natural |
| 63404-0201-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1f23-f424-e053-dadaa90a57ce | SprinJene ® SprinJene ® Natural Cavity Protection |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63404-0201-1 | SprinJene Natural | 99 g in 1 TUBE | PASTE, DENTIFRICE | 99 | 1 | |
| 63404-0201-1 | SprinJene Natural | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63404-0201 | SPRINJENE NATURAL (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] | 1 | Current NDC, Legacy NDC, 2 package rows | 20170201_e64cecc3-0845-4bdf-a449-d78248791ccf.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 Clean Breath Peppermint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f1ef07b-ee68-e6ae-e063-6394a90af5e5 | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f20343e-6c03-48e8-e063-6294a90a8cdf | 2026-04-10 | Warnings | M021 |
| Crest Clean Breath Smooth Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4f2042b4-8eae-5c2c-e063-6394a90a640c | 2026-04-10 | Warnings | M021 |
| Crest 3D White Advanced Arctic Fresh with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4146d-6281-fe66-e063-6394a90a32c3 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Glamorous White with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef5261e-9d2f-ae05-e063-6294a90a489a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Luminous Mint Daily Whitening Upkeep | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4f0876d9-41c9-d891-e063-6394a90a1cbd | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Charcoal with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef57a05-b9f5-42f7-e063-6294a90a5d89 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint with Stain Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ee26a82-16fd-f0fb-e063-6394a90a91d1 | 2026-04-09 | Warnings | M021 |
| Crest 3D White Whitening Therapy Deep Clean Charcoal | SODIUM FLUORIDE | Procter & Gamble Manfuacturing Company | 812c1519-1a4b-2495-e053-2a91aa0a914a | 2026-04-09 | Warnings | M021 |
| Crest 3D White Advanced Deep Clean with Stain-Blasting Foam | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 4ef4e7c2-1f58-59fc-e063-6294a90ad43b | 2026-04-08 | Warnings | M021 |
| Anticavity mouth rinse Low-foaming Spearmint | 779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINT | Dyson Technology Limited | 4ef669b9-defe-8965-e063-6394a90ab335 | 2026-04-08 | Warnings | M021 |
| Crest 3D White Advanced Radiant Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5c89efc-5fa0-2a05-e053-2a95a90a7b9c | 2026-04-07 | Warnings | M021 |
| Crest 3D White Advanced Charcoal | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f4eb8111-53da-17ae-e053-2a95a90a1127 | 2026-04-07 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | 35385ada-bd8d-4d38-9587-0256885f749f | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | ADUSA Distribution, LLC | cf0c8b48-0d1c-406a-a67d-7d16187d38d8 | 2026-04-07 | Warnings, Adverse reactions | M021 |
| Crest 3D White Arctic Fresh | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fa08a877-b9e5-4eba-b832-3a28f4f3f83c | 2026-04-07 | Warnings | M021 |
| Anticavity Fluoride | SODIUM FLUORIDE | Family Dollar (FAMILY WELLNESS) | 63c4c0e9-84b1-4076-bdf4-7e9543b2cf46 | 2026-04-01 | Warnings | M021 |
| CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 98a8cee8-9f3c-4a4a-89f8-72e1f1b06796 | 2026-04-01 | Warnings | M021 |
| CloSYS | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 5f87abb7-0e9d-6369-e053-2a91aa0a2411 | 2026-03-31 | Warnings | M021 |
| Crest Clean Breath Spearmint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 4e544d09-0cf3-f0c7-e063-6394a90a2369 | 2026-03-31 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | e64cecc3-0845-4bdf-a449-d78248791ccf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63404-0201-1 | 63404020101 | 1 TUBE in 1 CARTON (63404-0201-1) / 99 g in 1 TUBE | 1 tube | 2017-02-01 | No | No | Current |