FDA.reportPublic FDA data

NDC 65113-9003-2 - PIGMENT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
65113-9003
Requested NDC
65113-9003-2
Package NDCs from labels
65113-9003-1, 65113-9003-2
Manufacturer
G.S. COSMECEUTICAL USA, INC.
Effective date
2011-11-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
pigment gel ®G.S. COSMECEUTICAL USA, INC.2011-11-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65113-9003-12020-01-31C16284748780-19d75b9d0-6b1d-f424-e053-dadaa90a57cepigment gel ®
65113-9003-22020-01-31C16284748780-19d75b9d0-6b1d-f424-e053-dadaa90a57cepigment gel ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-9003-1PIGMENT7.4 mL in 1 BOTTLE, PLASTICGEL7.41
65113-9003-2PIGMENT29.5 mL in 1 BOTTLE, PUMPGEL29.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-9003PIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]12 package rows20111215_b0bf5462-bd6f-4233-aa03-344532f94271.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AEPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
HYDROQUINONEACTIVE MOIETYXV74C1N1AEPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
AZELAIC ACIDINACTIVE INGREDIENTF2VW3D43YTPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
GLUTATHIONEINACTIVE INGREDIENTGAN16C9B8OPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
HAMAMELIS VIRGINIANA LEAF WATERINACTIVE INGREDIENT8FP93ED6H2PIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
HYDROXYETHYL CELLULOSE (2000 MPA.S FOR 1% AQUEOUS SOLUTION)INACTIVE INGREDIENTS38J6RZN16PIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
KOJIC ACIDINACTIVE INGREDIENT6K23F1TT52PIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
PHENYLETHYL RESORCINOLINACTIVE INGREDIENTG37UFG162OPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
SILYBUM MARIANUM SEEDINACTIVE INGREDIENTU946SH95EEPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPIGMENT (HYDROQUINONE) GEL [G.S. COSMECEUTICAL USA, INC.]1

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 58 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOP Ethyl Alcohol 70%ETHYL ALCOHOLOmega & Delta Co., Inc.b96d85f8-739c-4b96-9dd5-8119ebf66c9f2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfcbe1-8e0c-1715-e063-6394a90a733f2026-01-21WarningsExact identifier
unii: 3K9958V90M
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLMY IMPORTS USA LLC48f0a73a-66b5-e7d0-e063-6394a90a23332026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLMY IMPORTS USA LLC48f127be-8259-5aaa-e063-6294a90a3f1a2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Rose LycheeETHYL ALCOHOLMY IMPORTS USA LLC48f2433f-b924-ade1-e063-6394a90a2c9a2026-01-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLMY IMPORTS USA LLC48f2527c-a83e-f709-e063-6394a90aa0302026-01-21WarningsExact identifier
unii: 3K9958V90M
Walgreens SWEET PEA PETALS Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.9867c899-980b-4272-8716-41e7c27cdcb82026-01-21WarningsExact identifier
unii: 3K9958V90M
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hand Sanitizing WipesALCOHOLGerms Be Gone LLC2bd6249b-f215-7aa9-e063-6394a90a65802026-01-20WarningsExact identifier
unii: 3K9958V90M
SPA HAND SANITIZER SUMMER LEMONETHYL ALCOHOLRejoice International Corp.48dd563a-0558-cc76-e063-6294a90ab0412026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry FreesiaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48de4a31-c620-6c1c-e063-6394a90abb962026-01-20WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar BlossomETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48df981a-74da-a629-e063-6294a90a7f402026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care COCO CABANA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.026aff02-33cf-486d-ae7f-0f0913ce83992026-01-20WarningsExact identifier
unii: 3K9958V90M
Hydroquinone 4%HYDROQUINONENivagen Pharmaceuticals, Inc.7844c308-e0a2-42e7-bd28-f68a59ebca832026-01-20Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE
Walgreens PEAR Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.a89f90e1-0696-4688-9503-5e6b3e7853bd2026-01-20WarningsExact identifier
unii: 3K9958V90M
Smart Care CITRUS SUNSET HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de33db2f-9329-4c42-b67f-de5358c547aa2026-01-19WarningsExact identifier
unii: 3K9958V90M
Scent Theory Hand Sanitizers Coastal Mist, Boardwalk Treats, Firecracker FreezeALCOHOLScent Theory Products LLC48c3d5e9-2d57-5a46-e063-6394a90a07222026-01-19WarningsExact identifier
unii: 3K9958V90M
Smart Care SWEET AND STILL HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.1086c3cd-5081-49ed-8380-7a7f31488f532026-01-19WarningsExact identifier
unii: 3K9958V90M
Walgreens WATERMELON Hand Sanitizer MistETHYL ALCOHOLWalgreen Co.08952596-4a48-4792-9d4d-008590c713122026-01-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.