Topco Associates LLC
- Product NDC
- 36800-364
- 11-digit product format
- 368000364
- Labeler code
- 36800
- Product ID
- 36800-364_47e514c6-af35-cdd8-e063-6394a90aea44
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Topco Associates LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-26
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 5; .15 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Topco Associates LLC
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 5 g/100g |
| SODIUM FLUORIDE | .15 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
| Rxcui | 1038929 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-364-10 | Topco Associates LLCMaximum Strength | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | | 3 |
| 36800-364-10 | Topco Associates LLCMaximum Strength | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 36800-364-10 | 36800036410 | 1 TUBE in 1 CARTON (36800-364-10) / 113 g in 1 TUBE | 1 tube | 2025-06-26 | No | No | Current |