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 124 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveHAND SANITIZER LAVENDERConopco Inc. d/b/a/ Unilevera736838b-b559-f066-e053-2995a90a90f52024-10-24WarningsExact identifier
unii: 3K9958V90M
TRI-LUMAFLUOCINOLONE ACETONIDE, HYDROQUINONE, AND TRETINOINGalderma Laboratories, L.P.a35fa709-5eb5-4429-b38f-f1e0019bf0ee2024-10-24Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE
CVS HEALTH CONTINUOUS HAND SANITIZERALCOHOLCVS PHARMACYc89a28ac-ab53-46dd-e053-2a95a90a32842024-10-22WarningsExact identifier
unii: 3K9958V90M
TRADER JOES HAND SANITIZER LAVENDERETHYL ALCOHOLTrader Joe's Company4d782831-dab8-4553-9786-b5172813553e2024-10-22WarningsExact identifier
unii: 3K9958V90M
TRADER JOES HAND SANITIZER GRAPEFRUIT LEMONALCOHOLTrader Joe's Companyf4c1e80a-847b-4407-92b7-570c032bea602024-10-22WarningsExact identifier
unii: 3K9958V90M
Venoforce IICOLLINSONIA CANADENSIS, HAMAMELIS VIRGINIANA, AESCULUS HIPPOCASTANUM, BELLADONNA, CALCAREA FLUORICA, CARDUUS MARIANUS, PULSATILLA (PRATENSIS), SECALE CORNUTUM, VIPERA BERUSBioActive Nutritional, Inc.a5226861-ad3e-4352-b31c-612f7fa993dd2024-10-18WarningsExact identifier
unii: U946SH95EE
Strength MARALIA QUINQUEFOLIA, AVENA SATIVA, DAMIANA, EPIMEDIUM GRANDIFLORUM, GLUTATHIONE, L-ARGININE, L-LEUCINE, L-ORNITHINE, L-VALINE, TESTOSTERONE, SABAL SERRULATA, SEPIABioActive Nutritional, Inc.8eda49aa-da6c-4e06-926c-73f35f33e5d82024-10-18WarningsExact identifier
unii: GAN16C9B8O
HAND SANITIZER RAINFALLALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b6-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER RASPBERRY MANGOALCOHOLSCENT THEORY PRODUCTS LLC24b19489-4e59-0df8-e063-6394a90af6ae2024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER BRAZILIAN COCONUTALCOHOLSCENT THEORY PRODUCTS LLC24b1992a-d695-32b2-e063-6394a90a6cab2024-10-17WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER LUSH ALOEALCOHOLSCENT THEORY PRODUCTS LLC24b1a25c-a3b8-9278-e063-6394a90a3ae22024-10-17WarningsExact identifier
unii: 3K9958V90M
Headache TonicCARDUUS MARIANUS, PYRETHRUM PARTHENIUM, SECALE CORNUTUM, ACONITUM NAPELLUS, BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SEPIA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.a6526cc4-028b-45df-ac1f-c3cec7556e932024-10-17WarningsExact identifier
unii: U946SH95EE
HAND SANITIZER SANDALWOOD WAVESALCOHOLSCENT THEORY PRODUCTS LLC24893800-464a-16ca-e063-6294a90a90652024-10-16WarningsExact identifier
unii: 3K9958V90M
INSTANT HAND SANITIZERINSTANT HAND SANITIZERRainbow Technology Corporation249d50e1-da31-1975-e063-6294a90afc842024-10-16WarningsExact identifier
unii: 3K9958V90M
ProGel Max Hand SanitizerALCOHOLDelta Pharma Inc.a607897c-c398-1931-e053-2a95a90ae4832024-10-16WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Insect Sting Relief Pad 1 ctBENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.b119ba37-0ee1-851a-e053-2995a90a85b12024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Antiseptic Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af08c1f3-b1c4-58aa-e053-2a95a90ab3202024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Hand Sanitizer Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af8466d7-794a-cb95-e053-2a95a90a6ffc2024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Hand Sanitizer with Cap Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af84bd67-4986-30e6-e053-2a95a90a8d932024-10-15WarningsExact identifier
unii: 3K9958V90M
Genuine First Aid Hand Sanitizer with Pump Ethyl AlcoholALCOHOLGFA Production (Xiamen) Co., Ltd.af84b665-260a-596f-e053-2995a90ac38c2024-10-15WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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