Home NDC 53208-568 EUTHYMOL WHITENING SET
Product NDC 53208-568
11-digit product format 532080568
Labeler code 53208
Product ID 53208-568_358399ee-bc12-06a1-e063-6394a90a9d96
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form KIT
Route DENTAL
Labeler LG HOUSEHOLD & HEALTH CARE LTD.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-09
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 EUTHYMOL WHITENING SET
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53208-566-63 EUTHYMOL WHITENING SET 106 g in 1 TUBE PASTE, DENTIFRICE 424 g in 4 1.5 mg in 1g 3 53208-566-65 EUTHYMOL WHITENING SET 4 in 1 CARTON PASTE, DENTIFRICE 1.5 mg in 1g 3 53208-566-73 EUTHYMOL WHITENING SET 70 g in 1 TUBE PASTE, DENTIFRICE 70 g 1.5 mg in 1g 3 53208-566-75 EUTHYMOL WHITENING SET 1 in 1 CARTON PASTE, DENTIFRICE 1.5 mg in 1g 3 53208-568-00 EUTHYMOL WHITENING SET 1 in 1 CARTON KIT 1 3
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 43 of 49 · 974 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 53208-566-63 53208056663 106 g in 1 TUBE 106 g Historical 53208-566-65 53208056665 4 in 1 CARTON Historical 53208-566-73 53208056673 70 g in 1 TUBE 70 g Historical 53208-566-75 53208056675 1 in 1 CARTON Historical 53208-568-00 53208056800 1 KIT in 1 CARTON (53208-568-00) * 4 TUBE in 1 CARTON (53208-566-65) / 106 g in 1 TUBE (53208-566-63) * 1 TUBE in 1 CARTON (53208-566-75) / 70 g in 1 TUBE (53208-566-73) 1 kit 2025-06-09 No No Current