Home NDC 83778-012 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 POTASSIUM CITRATE; PHTHALIMIDOPEROXYCAPROIC ACID; TRIBASIC CALCIUM PHOSPHATE
Active strength 3; 12; 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 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 TeethWhitening Kit
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM CITRATE 3 g/100mL PHTHALIMIDOPEROXYCAPROIC ACID 12 g/100mL TRIBASIC CALCIUM PHOSPHATE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EE90ONI6FF Internal UNII lookup 5OEJ6FAL6C Internal UNII lookup 91D9GV0Z28 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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.
Matched openFDA labels page 14 of 40 · 786 matching rows.
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 Current