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 131 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Ince7930ec4-6920-4abb-adce-8cc4de44801d2024-07-02WarningsExact identifier
unii: 3K9958V90M
VITAL IIARNICA MONTANA, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HYPOPHYSIS SUIS, PANAX GINSENG, L-ARGININE, OLEUM ANIMALE, SCHISANDRA CHINENSIS, TARAXACUM OFFICINALE, THUJA OCCIDENTALISLiddell Laboratories, Inc.04cded9a-0431-4e87-9055-ec4f381125592024-07-01WarningsExact identifier
unii: U946SH95EE
LIVER DETOXBRYONIA (ALBA), CARDUUS MARIANUS, CHELIDONIUM MAJUS, HEPAR SUIS, TARAXACUM OFFICINALELiddell Laboratories, Inc.e8337c7c-61fb-4c30-8814-13d90a6780b32024-07-01WarningsExact identifier
unii: U946SH95EE
Hand SanitizerETHYL ALCOHOLBiocosmetica Excel Argentinaaefcbf7b-3524-9e28-e053-2995a90a5a422024-06-30WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLExelencia Importers, Corp.abffec96-20e5-fd78-e053-2a95a90a4b082024-06-30WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Lemon ScentedALCOHOLFOURSTAR GROUP USA, INC.3fc74eff-46d6-45f5-bfa5-76a6a923cb942024-06-28WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Watermelon ScentedALCOHOLFourstar Group USA, Inc.102d3955-be15-4c1c-b097-c566d675ab7c2024-06-28WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Alcohol Cleansing PadBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.c39c4d80-9718-459f-8ae4-ada043bba5b72024-06-26WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Aloe ScentedALCOHOLFOURSTAR GROUP USA, INC.efd7a413-d29b-4b18-97bb-82746376e3df2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Eucalyptus ScentedALCOHOLFOURSTAR GROUP USA, INCd154ca37-a28d-48fb-94c8-add632c82bdc2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Gel LeavesALCOHOLBath & Body Works, Inc.1ba7e3fe-d83c-db66-e063-6394a90a3b3a2024-06-25WarningsExact identifier
unii: 3K9958V90M
b pure Hand Sanitizer Shea Butter ScentedALCOHOLFOURSTAR GROUP USA, INC.1eca1353-3422-4e78-96a5-dd4603c04aac2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Raspberries and Whipped VanillaALCOHOLBath & Body Works, Inc.1bbaa102-f43e-a7e8-e063-6394a90a89e82024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Mahogany CoconutALCOHOLBath & Body Works, Inc.1bba9390-36ba-20e2-e063-6294a90a4b882024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Kitchen MandarinALCOHOLBath & Body Works, Inc.1bbaa157-5f45-1c6c-e063-6294a90a11152024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel White Tea and SageALCOHOLBath & Body Works, Inc.1bba9834-3c87-f5af-e063-6394a90aa6bd2024-06-25WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Palo Santo and SageALCOHOLBath & Body Works, Inc.1ba4242c-4427-02e9-e063-6394a90a7c082024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pineapple MangoALCOHOLBath & Body Works, Inc.1ba44b0e-05bd-d7f3-e063-6294a90a6a0c2024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Passionfruit and Banana FlowerALCOHOLBath & Body Works, Inc.1ba427ce-1504-51ec-e063-6394a90a36742024-06-24WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink GumballALCOHOLBath & Body Works, Inc.1ba4d76b-8e17-c44d-e063-6294a90a6dc12024-06-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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