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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pearl White
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RU45X2JN0Z | Internal UNII lookup |
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 51c79544-9536-5863-e054-00144ff8d46c | Available on FDA.report |
DailyMed Package Descriptions#
| 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#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Chloraspetic | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | 2b1808b2-2574-4ab8-a762-5733251848ce | 2024-10-25 | Warnings | M022 |
| Chloraseptic Warming Sore Throat | PHENOL | Prestige Brands Holdings, Inc. | a197fab2-70ce-4a6c-9add-29d7368a75c5 | 2024-10-25 | Warnings | M022 |
| Gly-Oxide | CARBAMIDE PEROXIDE | Medtech Products Inc. | 086a0b82-e947-41c9-89e7-ba06483960c9 | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | d500f423-b9f2-4d98-8f2a-8bab7c05737c | 2024-10-25 | Warnings | M022 |
| CHLORASEPTIC | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | b30e4b32-89dd-4e53-81d5-1415105361d4 | 2024-10-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Efficient Laboratories Inc. | 28c5a993-fb5f-4091-af15-32ccae4b9a7d | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Freshmint | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 7e715bb9-666e-4de4-ba70-1c84f5243443 | 2024-10-14 | Warnings | M022 |
| Rexall Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | Old East Main CO. | 2daf18a3-f71e-4585-8128-4663eff7eb6d | 2024-10-14 | Warnings | M022 |
| Anadent Kanka Gel | BENZOCAINE | BELMORA LLC | e0f73d78-5db1-43b4-8f58-e5410ca4560f | 2024-10-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Navajo Manufacturing Company Inc. | f5f26e2f-8a1f-4687-e053-2a95a90ae378 | 2024-10-03 | Warnings | M022 |
| Colgate Great Regular Flavor | SODIUM MONOFLUOROPHOSPHATE | Navajo Manufacturing Company Inc. | f89bf259-b738-8229-e053-6394a90a0c59 | 2024-10-03 | Warnings | M022 |
| Colgate Total SF Clean Mint | STANNOUS FLUORIDE | Navajo Manufacturing Company Inc. | f71c53e0-e2dd-16f9-e053-6394a90accff | 2024-10-03 | Warnings | M022 |
| Crest Pro Health | CETYLPYRIDINIUM CHLORIDE | Navajo Manufacturing Company Inc. | 65bf17a9-21ad-27cb-e053-2991aa0afc40 | 2024-10-02 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | 94e07979-943b-45bb-8e2b-90d686f3692e | 2024-09-04 | Warnings | M022 |
| Sensodyne Pronamel Gentle Whitening Advanced Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | 6eb304dd-2a24-4fa0-9d39-71264e88dd16 | 2024-08-29 | Warnings | M022 |
| Sensodyne Pronamel Clinical Enamel Strength Deep Clean | POTASSIUM NITRATE, SODIUM FLUORIDE | Haleon US Holdings LLC | cfda7efa-86fa-470d-a79f-81907e31778a | 2024-08-14 | Warnings | M022 |
| Sensodyne Pronamel Kids Bubble Twist | SODIUM FLUORIDE | Haleon US Holdings LLC | e403529a-0fac-4dab-b75c-46906add096b | 2024-08-13 | Warnings | M022 |
| Calcium Carbonate Assorted Flavors | ANTACID TABLETS | NuCare Pharmaceuticals,Inc. | af10dfb6-fef3-3410-e053-2995a90a9130 | 2024-07-17 | Warnings | M022 |
| SENSODYNE Advanced Whitening Plus | POTASSIUM NITRATE | Haleon US Holdings LLC | f757ccdd-b316-4799-a34a-10edbb73da6b | 2024-07-12 | Warnings | M022 |
| dentalux SENSITIVE ANTI-CAVITY FLUORIDE | POTASSIUM NITRATE, SODIUM FLUORIDE | Lidl US, LLC | baef7f15-8082-4e61-8c08-8beda8ad40c0 | 2024-07-03 | Warnings | M022 |
Packages#
| 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 |