Denta 5000 Plus Sensitive
- Product NDC
- 16571-823
- 11-digit product format
- 165710823
- Labeler code
- 16571
- Product ID
- 16571-823_3d38b4ec-9283-448f-8fc5-d51cca9de7a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium fluoride and Potassium nitrate
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Rising Pharma Holdings, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2024-02-14
- 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
- Denta 5000 Plus 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-823-10 | Denta 5000 Plus Sensitive | 100 mL in 1 TUBE | GEL, DENTIFRICE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-823 | DENTA 5000 PLUS SENSITIVE (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 1 package rows | 20240217_585fb1f5-8c08-43bd-8be4-64adc065d9a2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-823-10 | 16571082310 | 100 mL in 1 TUBE (16571-823-10) | 100 ml | 2024-02-14 | No | No | Historical |