Enamelon
- Product NDC
- 48783-520
- 11-digit product format
- 487830520
- Labeler code
- 48783
- Product ID
- 48783-520_4847e71b-2083-917b-e063-6394a90a2df0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- stannous fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Premier Dental Products Company
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-01-01
- Substance
- STANNOUS FLUORIDE
- Active strength
- .00454 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| STANNOUS FLUORIDE | .00454 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3FTR44B32Q |
| Rxcui | 416784 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48783-520-43 | Enamelon | 122 g in 1 TUBE | PASTE, DENTIFRICE | 122 | | 7 |
| 48783-520-43 | Enamelon | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| STANNOUS FLUORIDE | ACTIVE INGREDIENT | 3FTR44B32Q | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) | INACTIVE INGREDIENT | 5216H1HX5F | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| LAUROYL SARCOSINE | INACTIVE INGREDIENT | LIJ19P3L6F | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 48783-520 | ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241027_1626375a-f78b-4192-b7f3-ca932acab7fb.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 |
|---|
| 48783-520-08 | 48783052008 | 1 TUBE in 1 CARTON (48783-520-08) > 21.2 g in 1 TUBE | 1 tube | 2014-01-01 | 0000-00-00 | No | No | Current |
| 48783-520-43 | 48783052043 | 1 TUBE in 1 CARTON (48783-520-43) / 122 g in 1 TUBE | 1 tube | 2014-01-01 | 0000-00-00 | No | No | Current |