PreviDent 5000 Enamel Protect
- Product NDC
- 0126-0022
- 11-digit product format
- 001260022
- Labeler code
- 0126
- Product ID
- 0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM FLUORIDE and POTASSIUM NITRATE
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Colgate Oral Pharmaceuticals, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-03-30
- 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
- PreviDent 5000 Enamel Protect
- Listing expiration
- 2027-12-31
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 |
|---|
| 0126-0022-92 | PreviDent 5000 Enamel Protect | 100 mL in 1 BOTTLE | GEL, DENTIFRICE | 100 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POTASSIUM NITRATE | ACTIVE INGREDIENT | RU45X2JN0Z | PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] | 1 | |
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] | 1 | |
| NITRATE ION | ACTIVE MOIETY | T93E9Y2844 | PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0126-0022 | PREVIDENT 5000 ENAMEL PROTECT (SODIUM FLUORIDE AND POTASSIUM NITRATE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20220820_bbc66b1b-e05c-4e14-bef3-b8bae419fc89.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0126-0022-12 | 00126002212 | 3.5 mL in 1 PACKET (0126-0022-12) | 3.5 ml | 2011-03-30 | 0000-00-00 | No | No | Current |
| 0126-0022-92 | 00126002292 | 100 mL in 1 BOTTLE (0126-0022-92) | 100 ml | 2011-03-30 | 0000-00-00 | No | No | Current |