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 126 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand ReliefLOTIONDerma Gloveffdfb167-0efa-4cd8-afdf-e1ff69ee62522024-10-09WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glove11c2939c-e77a-48f6-949c-9d508714012b2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Glovee6cfe092-cb2c-441b-8897-98626c43bef82024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove642cc56f-9f39-46be-bbd8-a2346a0efac42024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove93736944-7535-4035-93aa-4771138af8e32024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Glove39867f66-b641-4060-881d-161c2591d19c2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand ReliefLOTIONDerma Glove767cc1f2-89a2-4d0b-ae49-ad7b9afca18b2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Gloveb4ff67d6-27d6-4d31-a708-9c2e8d4f0f3e2024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Glove1c46e4da-7594-48b0-8e8d-8031891184202024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc07a891a3-dcf7-438f-bbf7-a20b2aa7d7d72024-10-09WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glovedd849fb3-95af-4a32-9687-3b966d456fbb2024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Gloved8705086-7209-4f13-bd54-604c90495f0a2024-10-09WarningsExact identifier
unii: 3K9958V90M
HandLOTIONDerma Gloved158394e-baec-4770-8ee8-19285722ca612024-10-09WarningsExact identifier
unii: 3K9958V90M
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsExact identifier
unii: 3K9958V90M
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsExact identifier
unii: 3K9958V90M
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsExact identifier
unii: 3K9958V90M
Bio Co-Enzyme PhaseCARDUUS MARIANUS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.afad858e-064f-454d-be78-da1501ffe8532024-10-04WarningsExact identifier
unii: U946SH95EE
Saluja MD Essential Hand SanitizerETHYL ALCOHOLAnita Saluja, Md, LLC5c112afc-2a3d-46b2-94a8-830e8ff830442024-10-04WarningsExact identifier
unii: 3K9958V90M
Hydration ComplexBOLDO, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, HYPERICUM PERFORATUM, GINKGO BILOBA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, GERMANIUM SESQUIOXIDE, SILICEA, CALCAREA FLUORICA, CALCAREA PHOSPHORICADeseret Biologicals, Inc.891265ff-2651-4d84-a77b-331e3eb7e3ec2024-10-04WarningsExact identifier
unii: U946SH95EE

Reported adverse events (FAERS/openFDA)#

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