Sodium Fluoride 5000 Plus
- Product NDC
- 69367-309
- 11-digit product format
- 693670309
- Labeler code
- 69367
- Product ID
- 69367-309_332a3cc9-03d0-4e9e-ab80-f597b4198aa0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- CREAM
- Route
- DENTAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2021-03-09
- Substance
- SODIUM FLUORIDE
- Active strength
- 5 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Fluoride 5000 Plus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 5 mg/g |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-309-51 | Sodium Fluoride 5000 Plus | 51 g in 1 TUBE | CREAM | 51 | | 7 |
| 69367-309-51 | Sodium Fluoride 5000 Plus | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-309 | SODIUM FLUORIDE 5000 PLUS (SODIUM FLUORIDE) CREAM [WESTMINSTER PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230707_157b975e-0229-4081-8d7d-b5f933e178e0.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 |
|---|
| 69367-309-51 | 69367030951 | 1 TUBE in 1 CARTON (69367-309-51) / 51 g in 1 TUBE | 1 tube | 2021-03-09 | 0000-00-00 | No | No | Current |