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 66 of 159 · 3,167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SnugZ Hand Sanitizer GelHAND SANITIZER GELSnugZ/USA, LLC69bc7a80-0898-4c08-e053-2a91aa0a87a92025-12-29WarningsExact identifier
unii: 3K9958V90M
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Dehydrated AlcoholALCOHOLAjenat Pharmaceuticals LLC636d6421-cadf-42b3-a431-ba40c06e36d22025-12-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Freshnap Plus - 80% Ethyl Alcohol ToweletteALCOHOL TOWELETTEKARI-OUT LLCf4ae66e3-323b-5e2e-e053-2995a90acf422025-12-27WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PISTACHIO MATCHA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limiteddfd59d2e-9036-486a-b25b-7e5fe23421ce2025-12-26WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHANOLZep Inc.c72cf71f-e639-2854-e053-2a95a90ab30e2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Handstand Instant Hand SanitizerETHYL ALCOHOLZep Inc.9984beca-a66a-785c-e053-2995a90ae5ba2025-12-26WarningsExact identifier
unii: 3K9958V90M
Zep Hand Sanitizer WipesETHANOLZep Inc.99867fc5-820e-6d6b-e053-2a95a90a07932025-12-26WarningsExact identifier
unii: 3K9958V90M
StellaLife Hand SanitizerALCOHOLStellaLife, Inc.a65b338d-5019-0cfc-e053-2a95a90ae8b22025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINEAPPLE SUNDAE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedddda3587-1967-474a-8d9b-c6dad5448b2c2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY KISS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited39c8767d-46e8-4b26-be52-e5ed7d090d3e2025-12-26WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COTTON CANDY CLOUDS SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6cac3768-0622-4151-abf5-97903ce1ea0e2025-12-26WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Lavender ChamomileALCOHOLTazza Brands East Inc.3c9afa9e-5109-bd0b-e063-6394a90ad8e52025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Peppermint LemonALCOHOLTazza Brands East Inc.3ddd9fa7-5e24-0781-e063-6394a90ae9512025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER Sweet Orange Vanilla SpiceALCOHOLTazza Brands East Inc.3dddc20c-5dba-2e19-e063-6394a90aac7f2025-12-25WarningsExact identifier
unii: 3K9958V90M
VibeMist HYDRATING HAND SANITIZER UNSCENTEDALCOHOLTazza Brands East Inc.3de26f8e-83ea-c04f-e063-6294a90ac0242025-12-25WarningsExact identifier
unii: 3K9958V90M
Sprayology TravelEaseAPIS MEL, CARBO VEG, CARDUUS MAR, COCCULUS, IGNATIA, NUX VOM, PASSIFLORA, TABACUMEight and Company L.L.C104c72b0-2892-4262-81b8-7f7f0184615a2025-12-24WarningsExact identifier
unii: U946SH95EE
Azelaic Acid GelAZELAIC ACIDEncube Ethicals, Inc.ab3f174c-a3c4-4ae9-b0bc-954efaadf8de2025-12-24Warnings, Adverse reactionsExact identifier
unii: F2VW3D43YT
Tazza 70% Alcohol-Based Hand Sanitizing FoamALCOHOLTazza Brands East, Inc.33452d7a-0436-99bb-e063-6294a90ad8c42025-12-24WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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