Enamelon Preventive Treatment
- Product NDC
- 48783-500
- 11-digit product format
- 487830500
- Labeler code
- 48783
- Product ID
- 48783-500_4847e624-6a03-7e43-e063-6394a90a5045
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- stannous fluoride
- Dosage form
- GEL
- Route
- DENTAL
- Labeler
- Premier Dental Products Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-01
- Substance
- STANNOUS FLUORIDE
- Active strength
- .004 g/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enamelon Preventive Treatment
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | .004 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 237847 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 04c3f178-7905-404d-9ac2-67c453287ddf | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 48783-500-40 | 2023-02-01 | C162847 | 48780-1 | f386c64a-0636-0266-e053-dadaa90a7c1a | Enamelon Gel |
| 48783-500-40 | 2023-01-30 | C162847 | 48780-1 | f386c64a-0636-0266-e053-dadaa90a7c1a | Enamelon Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 48783-500-40 | Enamelon Preventive Treatment | 113 g in 1 TUBE | GEL | 113 | 8 | |
| 48783-500-40 | Enamelon Preventive Treatment | 1 in 1 CARTON | GEL | 1 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| 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 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Nice-Pak Products, LLC | c71d4064-f938-477b-9346-eb38be65390d | 2026-08-25 | Warnings, Adverse reactions | M021 |
| AIM Whitening with Baking Soda | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 1d0fd0b4-33ba-5764-e054-00144ff88e88 | 2026-08-25 | Warnings | M021 |
| OPTIC WHITE PRO SERIES VIBRANT CLEAN | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | b1ada157-a9a0-4eec-83a2-6e448d7f12dc | 2026-08-21 | Warnings | M021 |
| Colgate Max Fresh Clean Mint | SODIUM FLUORIDE | Colgate-Palmolive Company | 7cb85fc4-573b-45d7-a430-f2fd17320c43 | 2026-08-21 | Warnings | M021 |
| Therabreath Whitening | SODIUM FLUORIDE | Church & Dwight Co., Inc. | 3ba04b55-38f9-76f3-e063-6394a90a3c03 | 2026-08-21 | Warnings | M021 |
| Therabreath Deep Clean | STANNOUS FLUORIDE | Church & Dwight Co., Inc. | 3c372f26-e0c4-0659-e063-6294a90ae9f9 | 2026-08-21 | Warnings | M021 |
| TheraBreath | POTASSIUM NITRATE, SODIUM FLUORIDE | Church & Dwight Co., Inc. | 4b812a38-f7cb-51c8-e063-6394a90ab82c | 2026-08-21 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Your Military Exchanges | eb95e0ca-a94c-41cb-9f54-6c64ed9a9733 | 2026-08-21 | Warnings, Adverse reactions | M021 |
| Pop On Toothpaste. | POP ON TOOTHPASTE. | POPONSMILES,LLC | 4a0edab5-ae36-91b5-e063-6294a90aa685 | 2026-08-21 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 188dc3ac-64c9-438e-858b-846f725c6ea0 | 2026-08-21 | Warnings | M021 |
| freshSTART Anticavity fluoride toothpaste. | ANTICAVITY FLUORIDE TOOTHPASTE | Guangzhou Xinuo Technology Co., Ltd. | 596432d5-3541-6dff-e063-6294a90a9d42 | 2026-08-19 | Warnings | M021 |
| COLGATE 2IN1 WHITENING STAIN LIFTERS | SODIUM FLUORIDE | Colgate-Palmolive Company | 26f1f873-06b2-45ef-a4b9-32f997642bc7 | 2026-08-17 | Warnings | M021 |
| COLGATE OPTIC WHITE PRO SERIES HI WHITE | SODIUM MONOFLUOROPHOSPHATE | Colgate-Palmolive Company | 8b210b6c-b712-4f14-906c-306922573a26 | 2026-08-17 | Warnings | M021 |
| SprinJene Natural | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | e64cecc3-0845-4bdf-a449-d78248791ccf | 2026-08-17 | Warnings | M021 |
| ATOMY ANTICAVITY TOOTH | SODIUM MONOFLUOROPHOSPHATE | ATOMY CO., LTD. | 592caccc-e3a9-9c66-e063-6394a90a26e3 | 2026-08-16 | Warnings | M021 |
| SprinJene Health Boost | SODIUM MONOFLUOROPHOSPHATE | Health and Natural Beauty USA Corp | 9be87bcd-403a-4d7e-8ded-9833249565d1 | 2026-08-14 | Warnings | M021 |
| SprinJene Fresh Boost | SODIUM FLUORIDE | Health and Natural Beauty USA Corp | 919f6f51-6c43-4f1c-9bc7-029bf76c0e68 | 2026-08-14 | Warnings | M021 |
| SprinJene Natural Sensitivity Relief | SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE | Health and Natural Beauty USA Corp | 32cc5bc2-60c9-4cb4-acde-485ae494aba2 | 2026-08-14 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 237847 | stannous fluoride 0.4 % Oral Gel | PSN | 04c3f178-7905-404d-9ac2-67c453287ddf | 8 |
| 237847 | stannous fluoride 0.004 MG/MG Oral Gel | SCD | 04c3f178-7905-404d-9ac2-67c453287ddf | 8 |
| 237847 | stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral Gel | SY | 04c3f178-7905-404d-9ac2-67c453287ddf | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 48783-500-40 | 48783050040 | 1 TUBE in 1 CARTON (48783-500-40) / 113 g in 1 TUBE | 1 tube | 2014-01-01 | 0000-00-00 | No | No | Current |