Home NDC 82168-004 Professional whitening tooth
Product NDC 82168-004
11-digit product format 821680004
Labeler code 82168
Product ID 82168-004_4c16da29-b13d-52ff-e063-6394a90aedda
Type HUMAN OTC DRUG
Nonproprietary name Professional whitening toothpaste
Dosage form PASTE
Route DENTAL
Labeler Guangzhou City Caiye Cosmetics CO., Ltd
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-13
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength .76 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
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 Professional whitening tooth
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE .76 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82168-004-01 Professional whitening tooth 100 g in 1 BOX PASTE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82168-004 PROFESSIONAL WHITENING TOOTH (PROFESSIONAL WHITENING TOOTHPASTE) PASTE [GUANGZHOU CITY CAIYE COSMETICS CO., LTD] 1 Current NDC, 1 package rows 20241215_291eba71-14da-fac3-e063-6294a90aa3cc.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 40 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82168-004-01 82168000401 100 g in 1 BOX (82168-004-01) 100 g 2024-12-13 No No Current