PRO Gel 5000
- Product NDC
- 61578-215
- 11-digit product format
- 615780215
- Labeler code
- 61578
- Product ID
- 61578-215_424ae751-1f8e-4e67-ba2e-b368d447053e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- DENTAL ALLIANCE HOLDINGS LLC
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2022-05-10
- Substance
- SODIUM FLUORIDE
- Active strength
- 5000 ug/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRO Gel 5000
- Brand name suffix
- Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 5000 ug/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 392038 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61578-215-01 | PRO Gel 5000Mint | 68 g in 1 TUBE, WITH APPLICATOR | GEL, DENTIFRICE | 68 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61578-215 | PRO GEL 5000 MINT (SODIUM FLUORIDE) GEL, DENTIFRICE PRO GEL 5000 CITRUS (SODIUM FLUORIDE) GEL, DENTIFRICE [DENTAL ALLIANCE HOLDINGS LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240202_f127e236-5207-948b-e053-2a95a90ab740.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 |
|---|
| 61578-215-01 | 61578021501 | 68 g in 1 TUBE, WITH APPLICATOR (61578-215-01) | 68 g | 2022-05-10 | 0000-00-00 | No | No | Current |