FDA.reportPublic FDA data

NDC 65113-9003-2 - 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
Requested NDC
65113-9003-2
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 75 of 159 · 3,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INSTANT HAND SANITIZER ClassicETHYL ALCOHOLUniversal Distribution Center LLC65faf3d6-4e1c-4092-ac77-f6d77bf49cd62025-11-20WarningsExact identifier
unii: 3K9958V90M
Vital Male Sexual EnergyARNICA MONTANA, AVENA SATIVA, CALADIUM SEGUINUM, CARDUUS MARIANUS, DAMIANA, GALIUM APARINE, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOPHYSIS SUIS, LYCOPODIUM CLAVATUM, NUPHAR LUTEUM, ORCHITINUM, PANAX GINSENG, PHOSPHORICUM ACIDUM, POPULUS TREMULOIDES, TESTOSTERONE, THUJA OCCIDENTALIS, THYMUS SUIS, THYROIDINUM SUISLiddell Laboratories, Inc.7467edf6-50a2-4773-83e2-d266c23e63982025-11-20WarningsExact identifier
unii: U946SH95EE
Tension HeadacheACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUSLiddell Laboratories, Inc.897a3348-4d9d-4f74-a330-d6492baa4d032025-11-20WarningsExact identifier
unii: U946SH95EE
everyone hand sanitizer coconut lemonETHYL ALCOHOLEO Products, LLCe42fae4c-4e6e-4309-b6fa-2fbb95c5cbc22025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes lavender aloeETHYL ALCOHOLEO Products, LLC8128b366-c2e3-4ffc-948f-299227a364a12025-11-20WarningsExact identifier
unii: 3K9958V90M
everyone hand sanitizer wipes coconut lemonETHYL ALCOHOLEO Products, LLC809049d8-a71e-44e1-986e-0473ee0fb6702025-11-19WarningsExact identifier
unii: 3K9958V90M
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
unii: 3K9958V90M
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
unii: 3K9958V90M
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
unii: 3K9958V90M
Liver LiquescenceCARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, UVA URSI, RAPHANUS SATIVUS, TARAXACUM OFFICINALE, LYCOPODIUM CLAVATUM, HYDRASTIS CANADENSIS, GALLBLADDER (BOVINE), HEPAR (BOVINE), BETA VULGARIS, PHOSPHORUSNutritional Specialties, Inc.84f9c2f6-cda2-4cfd-8485-7713806d705c2025-11-19WarningsExact identifier
unii: U946SH95EE
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
unii: 3K9958V90M
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLABC Compounding Co., Inc.ee46cb57-c79c-4edf-bc88-4a4f8a95bfc82025-11-18WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI World LLC5a4e26b4-7624-4451-a8ce-0832aa1572482025-11-17WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Coconut MilkALCOHOLI World LLCfa13c122-274a-4da7-b3a1-6bab294f3bee2025-11-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Barbie HAND SANITIZER COTTON CANDY SCENTETHYL ALCOHOLAshtel Studios, Inc.09a7ea30-9a07-4aca-87d5-1c56a210975d2025-11-16WarningsExact identifier
unii: 3K9958V90M
MistALCOHOLDerma Glove4513f6b9-ceac-415d-a1af-1f7585c5989e2025-11-14WarningsExact identifier
unii: 3K9958V90M
Hand RecoveryALCOHOLDerma Glove90058ba8-e55d-4318-9fc5-8f0d25dfdd992025-11-14WarningsExact identifier
unii: 3K9958V90M
hydroquinoneHYDROQUINONEMarlex Pharmaceuticals, Inc.be22c3e0-8760-1568-e053-2995a90a112a2025-11-13Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE

Reported adverse events (FAERS/openFDA)#

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