Sodium Fluoride 5000 ppm Enamel Protect
- Product NDC
- 11527-745
- 11-digit product format
- 115270745
- Labeler code
- 11527
- Product ID
- 11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride1.1%, Potassium Nitrate 5%
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Sheffield Pharmaceuticals LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2021-01-08
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 57.5; 5.8 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Fluoride 5000 ppm Enamel Protect
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 57.5 mg/mL |
| SODIUM FLUORIDE | 5.8 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11527-745-34 | Sodium Fluoride 5000 ppm Enamel Protect | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | | 1 |
| 11527-745-34 | Sodium Fluoride 5000 ppm Enamel Protect | 100 mL in 1 TUBE | GEL, DENTIFRICE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11527-745 | SODIUM FLUORIDE 5000 PPM ENAMEL PROTECT (SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%) GEL, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210112_83dfdead-4f71-404e-90ae-dbd6849c7cf1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11527-745-34 | 11527074534 | 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE | 1 tube | 2021-01-08 | 0000-00-00 | No | No | Current |