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 48 of 160 · 3,199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.4613ce33-6881-e7c8-e063-6394a90a40902026-03-09WarningsExact identifier
unii: 3K9958V90M
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
unii: 3K9958V90M
10% azelaic acid acne cream10% AZELAIC ACID ACNE CREAMGuangzhou Ariel Biotech Co., Ltd.233ed88c-7e76-f8ad-e063-6394a90aa53e2026-03-06WarningsExact identifier
unii: F2VW3D43YT
15% azelaic acid acne cream15% AZELAIC ACID ACNE CREAMGuangzhou Ariel Biotech Co., Ltd.234ce15d-99e5-c687-e063-6394a90a83572026-03-06WarningsExact identifier
unii: F2VW3D43YT
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, CHOLINUM, FEL TAURI, CALCAREA CARBONICA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d9ceea3f-c270-40fa-bf16-d83c683005ac2026-03-06WarningsExact identifier
unii: U946SH95EE
Advance PlusCARDUUS MARIANUS, CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA (ALBA), CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, URICUM ACIDUMVitaminMed, LLC97824fb3-e2b4-4807-943b-88e26b211bf12026-03-06WarningsExact identifier
unii: U946SH95EE
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact identifier
unii: 3K9958V90M
Smart Care PISTACHIO CREME HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e763a268-b8d0-4237-bf8e-28433c0e80b22026-03-05WarningsExact identifier
unii: 3K9958V90M
SSDC Gel Hand SanitizerALCOHOLEcolab Inc.56fd749e-67d2-4d6f-b681-c0a44db9eef32026-03-04WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
unii: 3K9958V90M
Avant Foaming Hand SanitizerALCOHOLB4 Soap LLC6cc57ff1-e49b-4c15-b997-886a29d3fe1c2026-03-04WarningsExact identifier
unii: 3K9958V90M
Upper Gi and Enzyme RestorationACETICUM ACIDUM, AGARICUS MUSCARIUS, ALOE, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINCHONA OFFICINALIS, GRAPHITES, IPECACUANHA, LAC DEFLORATUM, MENTHA PIPERITA, NUX VOMICA, SECALE CORNUTUM, TANACETUM VULGARE, TEUCRIUM MARUM AND ZINGIBER OFFICINALE.King Bio Inc.84e268e5-ba68-4ad6-84d4-d799c4ea91ee2026-03-04WarningsExact identifier
unii: U946SH95EE
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: U946SH95EE
Smart Care FRENCH VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.047f107b-c4d7-42d4-9c9c-5af8280be7582026-03-04WarningsExact identifier
unii: 3K9958V90M
Everyone Hand Sanitizer Lavender AloeALCOHOLEO Products, LLCd15c1fb9-b25b-45b8-a119-ee4c86c8d91c2026-03-03WarningsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLAmazon.Com Services LLC85421e9a-f1c9-4793-9479-8a072a610ed72026-03-03Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Starfruit SangriaALCOHOLBath & Body Works, Inc.387caf6b-fda0-a63f-e063-6294a90a041a2026-03-03WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLOld East Main Co.31a38e0e-41de-4638-9e86-df1923b64d522026-03-02Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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