Home NDC 53208-561 EUTHYMOL Extraordinary Pink Whitening
Product NDC 53208-561
11-digit product format 532080561
Labeler code 53208
Product ID 53208-561_139125f6-2d2e-e67a-e063-6394a90adf57
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler LG H&H CO., LTD.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-13
Substance SODIUM FLUORIDE
Active strength 1.6 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53208-561-06 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53208-561-06 0efc9e666f02…f202fb6c5f17…
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 Extraordinary Pink Whitening
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.6 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53208-561-06 EUTHYMOL Extraordinary Pink Whitening 106 g in 1 TUBE PASTE, DENTIFRICE 106 2 53208-561-06 EUTHYMOL Extraordinary Pink Whitening 1 in 1 CARTON PASTE, DENTIFRICE 1 2 53208-561-63 EUTHYMOL Extraordinary Pink Whitening 3 in 1 PACKAGE PASTE, DENTIFRICE 3 1 53208-561-63 EUTHYMOL Extraordinary Pink Whitening 106 g in 1 TUBE PASTE, DENTIFRICE 106 1 53208-561-65 EUTHYMOL Extraordinary Pink Whitening 5 in 1 PACKAGE PASTE, DENTIFRICE 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53208-561 EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG H&H CO., LTD.] 2 Current NDC, 2 package rows 20250125_05b1f105-6f75-7a45-e063-6394a90a58bc.zip 53208-561 EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG H&H CO., LTD.] 1 Current NDC, 3 package rows 20240315_13910b55-9b5d-af53-e063-6294a90acf5d.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 5 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 53208-561-06 53208056106 1 TUBE in 1 CARTON (53208-561-06) / 106 g in 1 TUBE 1 tube 2023-09-18 No No Current 53208-561-63 53208056163 3 in 1 PACKAGE Historical 53208-561-65 53208056165 5 PACKAGE in 1 PACKAGE (53208-561-65) / 3 TUBE in 1 PACKAGE (53208-561-63) / 106 g in 1 TUBE 5 package 2024-03-13 No No Current