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
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
- 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 |
|---|---|---|---|---|---|---|
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Lidl US, LLC | c47475aa-3125-410f-aa31-0add6e4ce125 | 2026-02-04 | Warnings, Adverse reactions | M021 |
| Crest 3D White Brilliance Pro Ultra White | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | f4c02924-95ee-09d2-e053-2995a90a8121 | 2026-02-03 | M021 | |
| Crest 3D White Stain Eraser Icy Clean Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | f5d97011-7be3-3b1c-e053-2a95a90ade86 | 2026-02-03 | M021 | |
| Anticavity | SODIUM FLUORIDE | Demoulas Super Markets, Inc. | c28c3475-efbb-4099-83ab-ab91bac9dfc3 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Anticavity Fluoride Rinse | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 65abfb4d-3a1e-42df-b343-f270ce60a3bf | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 102e4d9c-0fae-d48a-e063-6294a90aac94 | 2026-02-03 | Warnings | M021 |
| Crest Plus Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 08767b0f-ed6e-8d32-e063-6294a90a10cd | 2026-02-03 | Warnings | M021 |
| Crest Braces Care Anticavity Fluoride Rinse | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d8398cfd-9af6-690d-e053-2995a90a9b7c | 2026-02-03 | Warnings | M021 |
| AutoBrush bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | 2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460 | 2026-02-03 | Warnings | M021 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | d859d02d-a036-4d90-bed4-9a5c31e9e1ef | 2026-02-03 | Warnings | M021 |
| Glowing White | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 32faf47d-b64f-4454-9f14-51503504c6b5 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Sodium fluoride | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 2f5d3c75-1a11-47e1-b297-e2302177efe7 | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Demoulas Super Markets, Inc | 096e6a1d-316b-432a-bf27-70e8a13337cc | 2026-02-03 | Warnings, Adverse reactions | M021 |
| Listerine Total Care Extra Mild Alcohol Free Anticavity Fluoride Mouthwash | SODIUM FLUORIDE | Kenvue Brands LLC | 49d1932f-a85c-7b8f-e063-6394a90a6aca | 2026-02-02 | Warnings | M021 |
| Listerine Total Care Mild Alcohol Free Anticavity Fluoride Mouthwash | SODIUM FLUORIDE | Kenvue Brands LLC | 49d4f96f-e61f-e6e6-e063-6294a90ab0a0 | 2026-02-02 | Warnings | M021 |
| Brush Buddies Mouthwash Toy Story Wild West Watermelon | SODIUM FLUORIDE | Kingkey MBC Life Technology Group co., LTD. | 49d69901-0b07-b07d-e063-6394a90a3c34 | 2026-02-02 | Warnings | M021 |
| Brush Buddies Mouthwash Frozen Blizzard Berry | SODIUM FLUORIDE | Kingkey MBC Life Technology Group co., LTD. | 49d6c1c9-cd21-cac6-e063-6294a90a81d6 | 2026-02-02 | Warnings | M021 |
| Brush Buddies Mouthwash Disney Princesses Grand Grape | SODIUM FLUORIDE | Kingkey MBC Life Technology Group co., LTD. | 49d6f926-da4e-26df-e063-6294a90a1c0c | 2026-02-02 | Warnings | M021 |
| Brush Buddies Mouthwash Spidey and Hist Amazing Friends Peter Parker Punch | SODIUM FLUORIDE | Kingkey MBC Life Technology Group co., LTD. | 49d70b88-d57c-37cd-e063-6294a90a4a59 | 2026-02-02 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | Rite Aid Corporation | 54a8b884-969a-4a41-ac2a-bc1f1fe9f7fe | 2026-02-02 | Warnings, Adverse reactions | 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 |