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 156 of 159 · 3,178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
OLIVIA QUIDO BLEMISH ERASERHYDROQUINONEO Skin Care LLCdfc742ae-41b5-d64a-e053-2995a90a1a8f2022-06-05Warnings, Adverse reactionsExact identifier
unii: XV74C1N1AE
azelaic acidAZELAIC ACIDActavis Pharma, Inc.66298d50-d4e2-4852-bbab-581389c488cb2022-05-30Warnings, Adverse reactionsExact identifier
unii: F2VW3D43YT
Carduus MarianusCARDUUS MARIANUSHahnemann Laboratories, INC.dfedc54a-c979-8db3-e053-2a95a90a1a632022-05-26Exact identifier
unii: U946SH95EE
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Carduus MarianusCARDUUS MARIANUSOHM PHARMA INC.66f9b3c3-64e4-4693-b839-6b9a242cc96e2021-12-30WarningsExact identifier
unii: U946SH95EE
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: U946SH95EE
Detox Drainage LiverBOLDO, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA, CYNARA, FEL TAURI, HYDRASTIS, MYRICA, NUX VOMICA, STANNUM MET, TARAXACUM.OHM PHARMA INC.a9c00168-eacd-4f0b-9a29-44c02243e6c22021-12-29WarningsExact identifier
unii: U946SH95EE
Allergy ReliefALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, BLATTA ORIENTALIS, BOVISTA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, EUPHRASIA OFFICINALAS, GALPHIMIA GLAUCA, HEDERA HELIX, HYDRASTIS CANADENSIS, LUFFA OPERCULATA, NASTURTIUM AQUATICUM, OKOUBAKA, SABADILLA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE.OHM PHARMA INC.c3f64a9a-d2e7-4326-aeb0-22c3693f58322021-12-29WarningsExact identifier
unii: U946SH95EE
LivergenARNICA MONTANA, BRYONIA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, DNA, HEPAR SUIS, OLEUM ANIMALE, PANCREAS SUIS, TARAXACUM OFFICINALE.Sunway Biotech LLC0e72f898-9685-47c9-b617-00145254bf8c2021-12-29WarningsExact identifier
unii: U946SH95EE
Immune BoosterAPIS MELLIFICA, BAPTISIA TINCTORIA, CARDUUS MARIANUS, ECHINACEA ANGUSTIFOLIA, GALLUM APARINE, MERCURIUS CORROSIVUS, MERCURIUS SULPHURATUS RUBER, NITRICUM ACIDUM, SULPHUR IODATUM, THUJA OCCIDENTALIS.Sunway Biotech LLC9ae14a66-9f6b-4ca8-b335-f6f75ddb8d932021-12-29WarningsExact identifier
unii: U946SH95EE
azelaic acidAZELAIC ACIDGlenmark Pharmaceuticals Inc., USA0b5ab22e-c78a-4429-9a76-a4ba2d11fcde2021-12-23Warnings, Adverse reactionsExact identifier
unii: F2VW3D43YT
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GUNA LIVER PLUSSODIUM PYRUVATE - SILYBUM MARIANUM SEED - CHELIDONIUM MAJUS - FUMARIC ACID - PORK LIVER - TARAXACUM OFFICINALE - LYCOPODIUM CLAVATUM SPORE - SODIUM SULFATE - PHOSPHORUS - BERBERIS VULGARIS ROOT BARKGuna spaba44c46e-4509-2e4d-e053-2a95a90a9c952021-12-15WarningsExact identifier
unii: U946SH95EE
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc52cb98dc-6858-42bf-9c54-d20fb607dfbb2021-11-12WarningsExact identifier
unii: U946SH95EE
Azelaic Acid GelAZELAIC ACIDSandoz Inc.66178511-5c1a-4ecd-bc98-2ceb54e710ac2021-11-11Warnings, Adverse reactionsExact identifier
unii: F2VW3D43YT
Adrenal and DHEAARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA.ProBLEN44991952-c440-4a33-9423-a9369c8bab702021-10-22WarningsExact identifier
unii: U946SH95EE

Reported adverse events (FAERS/openFDA)#

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