Home NDC 85164-001 GLUTATHIONE
Product NDC 85164-001
11-digit product format 851640001
Labeler code 85164
Product ID 85164-001_44a00c99-d2c1-7e83-e063-6394a90abc79
Type HUMAN OTC DRUG
Nonproprietary name KOJIC ACIDSKIN LIGHTENING
Dosage form SOAP
Route TOPICAL
Labeler HANCHOYEANBIOTEC Co.,Ltd.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-17
Substance TOCOPHEROL; GLUTATHIONE; ALPHA-ARBUTIN; ASCORBIC ACID
Active strength .1; .1; .1; .1 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Ascorbic Acid [CS], Vitamin C [EPC]
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 GLUTATHIONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOCOPHEROL .1 g/100g GLUTATHIONE .1 g/100g ALPHA-ARBUTIN .1 g/100g ASCORBIC ACID .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 85164-001-01 GLUTATHIONE 100 g in 1 BOX SOAP 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85164-001 GLUTATHIONE (KOJIC ACIDSKIN LIGHTENING) SOAP [HANCHOYEANBIOTEC CO.,LTD.] 1 Current NDC, 1 package rows 20250119_2be274be-e6d0-d961-e063-6294a90a2190.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 45 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85164-001-01 85164000101 100 g in 1 BOX (85164-001-01) 100 g 2025-01-17 No No Current