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 Complete plus Whitening plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c5d5bc17-e81b-34aa-e053-2a95a90ad77f | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c5745cc4-213d-1dde-e053-2995a90af562 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960fef18-4533-5250-e053-2995a90aaf76 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c574b51d-07bd-b363-e053-2995a90a7c0e | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Blast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6d9a1754-8d38-054f-e053-2991aa0a4653 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Breath Purify and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c60fdacf-d997-19a5-e053-2a95a90a96a3 | 2026-01-08 | Warnings | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d7fffb9-47e0-73cd-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Ultra | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c73ed36a-0e2f-a137-e053-2a95a90a43e0 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Extra Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c688d37e-9e80-4599-e053-2a95a90a1916 | 2026-01-08 | Warnings | M021 |
| Crest Gum Detoxify plus Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 63779942-0f6c-11c5-e053-2991aa0a25ab | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Sensitivity Active Foam | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | b8535d1c-cf15-f353-e053-2a95a90a7974 | 2026-01-08 | Warnings | M021 |
| Burts Bees Extra White Zen Peppermint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 81279e1f-6224-8114-e053-2991aa0aab08 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Bacteria Shield and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c74229c4-b095-df32-e053-2a95a90a4aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | c8350ab3-9347-58c0-e053-2995a90a7238 | 2026-01-08 | M021 | |
| Crest Premium Plus Anti-Bacterial | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | b7af946e-1cac-b8c0-e053-2a95a90afa4a | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Polishing Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ddcb0871-9900-125f-e053-2a95a90a75de | 2026-01-08 | M021 | |
| Burts Bees Deep Clean plus Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c924b8dd-8d84-1329-e053-2995a90a4531 | 2026-01-08 | Warnings | M021 |
| Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 07ed767e-225c-e9c5-e063-6394a90af931 | 2026-01-08 | Warnings | M021 |
| Crest Plus Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 0813171e-bda5-b004-e063-6394a90ad364 | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 087b3434-2636-74ce-e063-6394a90a25ad | 2026-01-08 | 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 |