Pearl White
- Product NDC
- 42199-006
- 11-digit product format
- 421990006
- Labeler code
- 42199
- Product ID
- 42199-006_0b3e6b1d-3644-3f2c-e063-6394a90a25a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Potassium nitrate, Sodium fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Beyond International Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-12
- Marketing end
- 2026-11-27
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 50; 1 mg/g; mg/g
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pearl White
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1 mg/g |
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 |
|---|
| 42199-006-05 | Pearl White | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | | 2 |
| 42199-006-05 | Pearl White | 120 g in 1 TUBE | PASTE, DENTIFRICE | 120 | | 2 |
| 42199-006-06 | Pearl White | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | | 2 |
| 42199-006-06 | Pearl White | 40 g in 1 TUBE | PASTE, DENTIFRICE | 40 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42199-006 | PEARL WHITE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BEYOND INTERNATIONAL INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20231129_51c79544-9536-5863-e054-00144ff8d46c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42199-006-05 | 42199000605 | 1 TUBE in 1 CARTON (42199-006-05) / 120 g in 1 TUBE | 1 tube | 2017-06-12 | 2026-11-27 | No | No | Current |
| 42199-006-06 | 42199000606 | 1 TUBE in 1 CARTON (42199-006-06) / 40 g in 1 TUBE | 1 tube | 2017-06-12 | 2026-11-27 | No | No | Current |