FDA.reportPublic FDA data

NDC 65113-9003 - 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
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 142 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
unii: 3K9958V90M
Algonquin HanSanALCOHOLWhisk Products, Inc.1808f5ab-4bee-4768-995b-911b10cfa18b2023-12-08WarningsExact identifier
unii: 3K9958V90M
D-GermALCOHOLWhisk Products, Inc.fe08fb0c-007c-40a7-e053-6294a90acac92023-12-08WarningsExact identifier
unii: 3K9958V90M
Pacific Breeze Instant Hand Sanitizer GelALCOHOLWhisk Products, Inc.3f574300-b05a-4f98-98fa-dd2177bb3d752023-12-08WarningsExact identifier
unii: 3K9958V90M
Pretty Pump Hand SanitizerALCOHOLWhisk Products, Inc.c6d6ca9a-9fe7-4a6d-8179-e085a4b414c82023-12-08WarningsExact identifier
unii: 3K9958V90M
AP HanSanALCOHOLWhiskProducts, Inc.e212fd90-f4e4-44c4-bfb7-16e313c30be92023-12-07WarningsExact identifier
unii: 3K9958V90M
Aire-Master Waterless Hand SanitizerALCOHOLWhisk Products, Inc.8f0b77b1-ef16-4a3c-874b-07f78d6a45b72023-12-07WarningsExact identifier
unii: 3K9958V90M
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
unii: 3K9958V90M
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
ALCOHOL ANTISEPTIC HAND SANITIZERALCOHOLCustom Quest, Inc.70dd10e3-1958-43a6-af7e-29ca900b00f62023-12-04WarningsExact identifier
unii: 3K9958V90M
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDb57c7e3a-f0bf-fd42-e053-2a95a90a3b4f2023-12-01WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLASC Marketing LTDb57c8ae8-dfb1-a959-e053-2995a90abddf2023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56d6034-cac2-a9e2-e053-2a95a90aebf02023-12-01WarningsExact identifier
unii: 3K9958V90M
Antibacterial Hand SanitizerALCOHOLASC Marketing LTDb56dc975-af3c-fdbe-e053-2a95a90a647b2023-12-01WarningsExact identifier
unii: 3K9958V90M
AZX Wellness Hand SanitizerALCOHOLASC Marketing LTDbf0098ab-6c0d-ecd2-e053-2a95a90a670c2023-12-01WarningsExact identifier
unii: 3K9958V90M
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus scented Hand SanitizingALCOHOLFourstar Group USA, Inc.809f18fa-46ad-4366-bb76-96ab0e787ded2023-11-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Lavender Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.5ca7c520-d099-4900-9e37-7f624397e5782023-11-30WarningsExact identifier
unii: 3K9958V90M
B-Pure Citrus Scented Hand SanitizerALCOHOLFourstar Group USA, Inc.0a22230e-d511-041d-e063-6394a90aade92023-11-30WarningsExact identifier
unii: 3K9958V90M
Unscented Hand SanitizerALCOHOLRaining Rosef706620b-15b3-4468-e053-6394a90a83172023-11-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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