Sodium Fluoride 1.1%
- Product NDC
- 35573-435
- 11-digit product format
- 355730435
- Labeler code
- 35573
- Product ID
- 35573-435_43929099-b98f-86b0-e063-6394a90a83e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Burel Pharmaceuticals LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2020-02-28
- Substance
- SODIUM FLUORIDE
- Active strength
- 5 mg/g
- 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 1.1%
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 1486566 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-435-56 | Sodium Fluoride 1.1% | 56 g in 1 TUBE | GEL, DENTIFRICE | 56 | | 5 |
| 35573-435-56 | Sodium Fluoride 1.1% | 1 in 1 CARTON | GEL, DENTIFRICE | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-435 | SODIUM FLUORIDE 1.1% (SODIUM FLUORIDE) GEL, DENTIFRICE [BUREL PHARMACEUTICALS LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221217_6e021467-08b3-40b3-9a39-2e9d9830085d.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 |
|---|
| 35573-435-56 | 35573043556 | 1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBE | 1 tube | 2020-02-28 | 0000-00-00 | No | No | Current |