TeethWhitening Kit
- Product NDC
- 83778-012
- 11-digit product format
- 837780012
- Labeler code
- 83778
- Product ID
- 83778-012_29ae5783-e7c6-a892-e063-6394a90a47e2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TeethWhitening Kit
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Jiangxi Dentalbright Technology Co., Ltd.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-14
- Substance
- PHTHALIMIDOPEROXYCAPROIC ACID; POTASSIUM CITRATE; TRIBASIC CALCIUM PHOSPHATE
- Active strength
- 12; 3; 1 g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TeethWhitening Kit
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHTHALIMIDOPEROXYCAPROIC ACID | 12 g/100mL |
| POTASSIUM CITRATE | 3 g/100mL |
| TRIBASIC CALCIUM PHOSPHATE | 1 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5OEJ6FAL6C, EE90ONI6FF, 91D9GV0Z28 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83778-012-01 | TeethWhitening Kit | 6 mL in 1 BOTTLE | CREAM | 6 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83778-012 | TEETHWHITENING KIT CREAM [JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD.] | 2 | Current NDC, 1 package rows | 20241222_29393313-217a-dc3a-e063-6294a90addb1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83778-012-01 | 83778001201 | 6 mL in 1 BOTTLE (83778-012-01) | 6 ml | 2024-12-14 | No | No | Historical |