DentaGel
- Product NDC
- 16571-815
- 11-digit product format
- 165710815
- Labeler code
- 16571
- Product ID
- 16571-815_6ff13596-e232-4e07-bb60-b1d88a01b503
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium fluoride
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2023-05-09
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.1 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DentaGel
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 1.1 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 392038, 1101938 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16571-815-60 | DentaGel | 56 g in 1 TUBE | GEL | 56 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-815 | DENTAGEL (SODIUM FLUORIDE) GEL [RISING PHARMA HOLDINGS, INC.] | 1 | Current NDC, 1 package rows | 20230511_cda9e1f6-275d-43ba-9e30-f34094e80d95.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-815-60 | 16571081560 | 56 g in 1 TUBE (16571-815-60) | 56 g | 2023-05-09 | No | No | Historical |