Sodium Fluoride 1.1% Gel
- Product NDC
- 69367-310
- 11-digit product format
- 693670310
- Labeler code
- 69367
- Product ID
- 69367-310_d90dff78-94ae-4d62-8283-a30652b7c16c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL
- 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 1.1% Gel
- 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 |
|---|
| 69367-310-56 | Sodium Fluoride 1.1% Gel | 56 g in 1 TUBE | GEL | 56 | | 7 |
| 69367-310-56 | Sodium Fluoride 1.1% Gel | 1 in 1 CARTON | GEL | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-310 | SODIUM FLUORIDE 1.1% GEL (SODIUM FLUORIDE) GEL [WESTMINSTER PHARMACEUTICALS, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230707_1822c957-0bd6-4e86-a030-80e6e428063a.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 |
|---|
| 69367-310-56 | 69367031056 | 1 TUBE in 1 CARTON (69367-310-56) / 56 g in 1 TUBE | 1 tube | 2021-03-09 | 0000-00-00 | No | No | Current |