Sodium Fluoride 5000 ppm Sensitive
- Product NDC
- 11527-704
- 11-digit product format
- 115270704
- Labeler code
- 11527
- Product ID
- 11527-704_c850c90a-b9bc-44b7-b30c-3f297f3ae164
- 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
- 2020-03-26
- 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 Sensitive
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11527-704-42 | Sodium Fluoride 5000 ppm Sensitive | 100 mL in 1 TUBE | GEL, DENTIFRICE | 100 | | 2 |
| 11527-704-42 | Sodium Fluoride 5000 ppm Sensitive | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11527-704 | SODIUM FLUORIDE 5000 PPM SENSITIVE (SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%) GEL, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20200402_02f4cf0b-188c-4522-b759-ffe4a9d150e8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11527-704-42 | 11527070442 | 1 TUBE in 1 CARTON (11527-704-42) / 100 mL in 1 TUBE | 1 tube | 2020-03-26 | 0000-00-00 | No | No | Current |