FDA.reportPublic FDA data

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
IngredientStrength
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.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R0ZB2556P8Internal UNII lookup
GAN16C9B8OInternal UNII lookup
72VUP07IT5Internal UNII lookup
PQ6CK8PD0RInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2be274be-e6d0-d961-e063-6294a90a2190Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85164-001-01GLUTATHIONE100 g in 1 BOXSOAP1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85164-001GLUTATHIONE (KOJIC ACIDSKIN LIGHTENING) SOAP [HANCHOYEANBIOTEC CO.,LTD.]1Current NDC, 1 package rows20250119_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 68 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85164-001-0185164000101100 g in 1 BOX (85164-001-01) 100 g2025-01-17NoNoCurrent