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 table| Ingredient | Strength |
|---|
| STANNOUS FLUORIDE | .004 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3FTR44B32Q |
| Rxcui | 237847 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 48783-500 | ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241027_04c3f178-7905-404d-9ac2-67c453287ddf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |