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 158 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrainerCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Newton Laboratories, Inc.9a008b9f-5db5-fac0-e053-2995a90a17c62020-12-02WarningsExact identifier
unii: U946SH95EE
DetoxifierURICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGONewton Laboratories, Inc.92ad49e0-2cfe-7d51-e053-2995a90a16f52020-11-24WarningsExact identifier
unii: U946SH95EE
Hand Sanitizer Lemon 2ozALCOHOLNingbo Rejoice Internationalb0a4159a-cb07-4ce6-e053-2995a90a76e72020-10-02WarningsExact identifier
unii: 3K9958V90M
ArtalgiaCARDUUS MARIANUS, ARNICA MONTANA, AGARICUS MUSCARIUS, BARYTA CARBONICA, BELLIS PERENNIS, GLONOINUM, HAMAMELIS VIRGINIANA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SECALE CORNUTUM, VANADIUM METALLICUM, CARBO VEGETABILIS, HYPERICUM PERFORATUM, PHOSPHORUS PULSATILLA (PRATENSIS), RHUS TOXTodd Horton DPM9404b908-5b1c-44b0-a9ff-35f3768b8ed72020-07-15WarningsExact identifier
unii: U946SH95EE
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
OBAGI-C Rx system C-CLARIFYING SERUM NORMAL TO oily SKIN LIGHTENING SERUM WITH VITAMIN CHYDROQUINONEObagi Cosmeceuticals LLC18803dfb-5b9c-48cd-a838-519c8bac33612020-06-02Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE
Obagi-C Rx system C-Therapy Night Skin Lightening with Vitamins C and EHYDROQUINONEObagi Cosmeceuticals LLC81e2e734-01fe-4568-903a-92993bf408872020-06-01Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE
DrainageCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
unii: U946SH95EE
Sanix Alcohol Hand RubALCOHOLTopiderm, Inca4fbb714-4f20-400a-ab98-f1c8807ce6fc2020-03-24WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
E.N.V.BELLADONNA, BERBERIS VULG, CARDUUS MAR, CHELIDONIUM MAJ, COLOCYNTHIS, DIOSCOREA, HYDRASTIS, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, PHOS, PULSATILLA, VERATRUM ALBZorex International838498ba-cab9-4e1b-a567-e7f1862b7fbb2018-12-21WarningsExact identifier
unii: U946SH95EE
GUNA-LIVERCEANOTHUS AMERICANUS LEAF - CHELIDONIUM MAJUS - CHIONANTHUS VIRGINICUS BARK - CHOLINE HYDROXIDE - COBALAMIN - CULVER ROOT - FUMARIC ACID - INOSITOL - LYCOPODIUM CLAVATUM SPORE - NIACIN - PORK LIVER - POTASSIUM SULFATE - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SILYBUM MARIANUM SEED - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA GALL BLADDER - SUS SCROFA JEJUNUM - SUS SCROFA PANCREAS - SUS SCROFA SPLEEN - TARAXACUM OFFICINALE - THIAMINE HYDROCHLORIDE -Guna spaab42235e-6080-492c-b5f2-fdbeb663a24d2018-12-21WarningsExact identifier
unii: U946SH95EE
GUNA-REACTANGELICA SINENSIS ROOT - ARNICA MONTANA - ASIAN GINSENG - ECHINACEA ANGUSTIFOLIA - FOMITOPSIS PINICOLA FRUITING BODY - INTERFERON GAMMA-1B - PAEONIA OFFICINALIS ROOT - PORK LIVER - REISHI - SILYBUM MARIANUM SEED - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - TURMERIC -Guna spac2b64907-1ae2-4686-b13c-847dbb84724e2018-12-21WarningsExact identifier
unii: U946SH95EE
OMEOSPORT.ALPHA.-KETOGLUTARIC ACID - ACONITIC ACID, CIS - ADENOSINE TRIPHOSPHATE - ALPHA LIPOIC ACID - ASCORBIC ACID - ASIAN GINSENG - BARIUM CATION - BEET - CEROUS OXALATE NONAHYDRATE - COENZYME A - CYSTEINE - FUMARIC ACID - LACTIC ACID, DL - MAGNESIUM CARBONATE - MALIC ACID - MANGANESE PHOSPHATE, DIBASIC - PORK - PYRIDOXINE HYDROCHLORIDE - RIBOFLAVIN - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SUCCINIC ACID - SUS SCROFA ADRENAL GLAND - THIAMINE HYDROCHLORIDE - SUS SCROFA EMBRYO -Guna spa119a205d-0074-48ff-ac78-e2300db452272018-12-21WarningsExact identifier
unii: 33X04XA5AT
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: U946SH95EE
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Foaming Mousse Anti-Bacterial Hand Sanitizer Pink Grapefruit ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.461859ad-7833-47ae-90da-1dea5f26cc4b2018-12-01WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Pineapple ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f8139155-865c-40e5-a5c5-58a629361a0b2018-11-28WarningsExact identifier
unii: 3K9958V90M
Foaming Mousse Anti-Bacterial Hand Sanitizer Cherry ScentedALCOHOLGanzhou Olivee Cosmetic Co., Ltd.35bd0f8f-1602-4713-b20f-8dc38e2761c22018-11-28WarningsExact identifier
unii: 3K9958V90M
Afassco Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.efbcbfe1-27c6-45c9-b51e-926e298ee7532018-10-18WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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