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 112 of 160 · 3,199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. TalbotsETHYL ALCOHOLTalbots Pharmaceuticals Family Products, LLC.a6a94205-a9ff-7709-e053-2995a90a066b2025-01-08WarningsExact identifier
unii: 3K9958V90M
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PentaCleanse Alcohol WipesALCOHOLPrestige Care Pharmacy Ince41a3e03-af01-5280-e053-2a95a90a8afc2025-01-08WarningsExact identifier
unii: 3K9958V90M
Quercus BoragoQUERCUS BORAGOUriel Pharmacy Inc.8243228b-89ec-2b53-e053-2a91aa0a0f382025-01-07WarningsExact identifier
unii: U946SH95EE
Gel Antiseptico DermowipeGEL ANTISEPTICO A BASE DE ALCOHOL ETILICOKey Qumica S.A. de C.V.15620afc-d6ae-0f34-e063-6294a90a8ad22025-01-07WarningsExact identifier
unii: 3K9958V90M
Sipa hand sanitizer with MoisturizersINSTANT HAND SANITIZERTourel (Changsha)Hotel Supplies Co.,Ltdfcbad83b-b8aa-a780-e053-6294a90a58ab2025-01-07WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLWater-Jel Technologies54e62104-8076-41db-afe5-6dc5c3563acc2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Gingerbread BakeryALCOHOLBath & Body Works, Inc.2b0f53e3-eb4c-a372-e063-6394a90ae5df2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel WinterALCOHOLBath & Body Works, Inc.2b0f4ddc-2384-3841-e063-6394a90aa2952025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Deep OceanALCOHOLBath & Body Works, Inc.2b0f3f65-746c-44ea-e063-6294a90a91852025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pink Sparkling SpritzALCOHOLBath & Body Works, Inc.2b0f3ca1-0a65-08a6-e063-6294a90a9df22025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Paris AmourALCOHOLBath & Body Works, Inc.2b0f525b-ff65-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Fresh BalsamALCOHOLBath & Body Works, Inc.2b0f3ca1-0a64-08a6-e063-6294a90a9df22025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Perfect in PinkALCOHOLBath & Body Works, Inc.2b0f4b8f-b046-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Twisted PeppermintALCOHOLBath & Body Works, Inc.2b0f4b8f-b041-8f98-e063-6394a90ac9b72025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Snowy Peach BerryALCOHOLBath & Body Works, Inc.2b0f466b-8e08-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne In ParisALCOHOLBath & Body Works, Inc.2b0f525b-ff63-9160-e063-6394a90a4cc12025-01-06WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender LuxeALCOHOLBath & Body Works, Inc.2b0f466b-8e0c-8f9c-e063-6394a90ae8ab2025-01-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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