FDA.reportPublic FDA data

NDC 42783-501 - NicAzel

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
42783-501
Package NDCs from labels
42783-501-60
Manufacturer
Elorac, Inc
Effective date
2021-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NicAzel - Elorac, IncElorac, Inc2021-12-08DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-501-60NicAzel60 in 1 BOTTLETABLET, COATED6020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-501NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]201 package rows20211209_fc729ca5-3846-48fd-8d8c-d2b6a7563741.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42783-501-60EA - Each42783-501312fc95a-cd2a-4773-be17-bce5e37bd3ef12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZELAIC ACIDACTIVE INGREDIENTF2VW3D43YTNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
COPPERACTIVE INGREDIENT789U1901C5NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
FOLIC ACIDACTIVE INGREDIENT935E97BOY8NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
NIACINAMIDEACTIVE INGREDIENT25X51I8RD4NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6ZNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
ZINCACTIVE INGREDIENTJ41CSQ7QDSNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
AZELAIC ACIDACTIVE MOIETYF2VW3D43YTNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
COPPERACTIVE MOIETY789U1901C5NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
FOLIC ACIDACTIVE MOIETY935E97BOY8NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
NIACINAMIDEACTIVE MOIETY25X51I8RD4NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
ZINCACTIVE MOIETYJ41CSQ7QDSNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICAZEL (NICOTINAMIDE, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET, COATED [ELORAC, INC]10

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 111 of 160 · 3,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VaccistatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, ALUMINA, ANTIMONIUM TARTARICUM, MEZEREUM, NATRUM MURIATICUM, MERCURIUS SOLUBILIS, SILICEA, THUJA OCCIDENTALIS, MALANDRINUM, VARIOLINUMEnergique, Inc.5205cc3e-c9bc-48e9-9c9b-959a9be78b852024-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 789U1901C5
unii: 15FIX9V2JP
unii: J41CSQ7QDS
Folic AcidFOLIC ACIDBryant Ranch Prepackf4ede23e-f091-46cb-b120-772ee71b8cb32024-10-31Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Upper Resp HPCARBO VEGETABILIS, CUPRUM METALLICUM, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, IPECACUANHA, LACHESIS MUTUS, LOBELIA INFLATA, PHOSPHORUS, PULSATILLA (PRATENSIS), RUMEX CRISPUS, SPONGIA TOSTAEnergique, Inc.a9c72c3a-908a-433b-ba9e-4f525b80ecaa2024-10-31WarningsExact identifier
unii: 789U1901C5
SiliceaSILICEAEnergique, Inc.7ac17e38-d6e2-4cc9-8fcb-cbfa0d60223b2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
ScarstatCALENDULA OFFICINALIS, GRAPHITES, HYPERICUM PERFORATUM, SILICEA, STAPHYSAGRIA, THIOSINAMINUMEnergique, Inc.1decc2eb-1261-46b8-908e-a152535b4a022024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
Spleenex VHARALIA QUINQUEFOLIA, GINKGO BILOBA, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, COBALTUM METALLICUM, NICCOLUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, BARYTA CARBONICA, PHOSPHORICUM ACIDUM, ACONITICUM ACIDUM, CIS, MAGNESIUM GLUCONICUM DIHYDRICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.54e2c88e-2483-4c38-86e5-19e218e713ae2024-10-30WarningsExact identifier
unii: J41CSQ7QDS
SILICEASILICEAEnergique, Inc.395f400d-6a87-4da9-aa1f-edca9729f1ac2024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
Scrophulous HPBARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, FERRUM IODATUM, GNAPHALIUM POLYCEPHALUM, MERCURIUS SOLUBILIS, PHYTOLACCA DECANDRA, RHUS TOX, SILICEAEnergique, Inc.e50eb26b-6843-4b8f-8ea5-3d5f57a3e7b42024-10-30WarningsExact identifier
unii: ETJ7Z6XBU4
Spleenex VARALIA QUINQUEFOLIA, POTASSIUM GLUCONATE, GINKGO BILOBA, MAGNESIUM GLUCONICUM DIHYDRICUM, PANCREAS SUIS, SPLEEN (SUIS), STOMACH (SUIS), GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, ZINCUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIA PHOSPHORICA, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOCHINONUM, ACONITICUM ACIDUM, CIS-, NATRUM OXALACETICUMEnergique, Inc.effbaa07-239b-42f2-afd4-0eeeba7de1fd2024-10-30WarningsExact identifier
unii: 789U1901C5
unii: J41CSQ7QDS
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
Chavita 1CARBO VEG, OOPHORINUM, SILICEA, OLIBANUM, ORCHITINUM, URTICA URENSRUBIMED AG0ade088f-0ff2-4894-9aed-d0b0cfdde38d2024-10-29WarningsExact identifier
unii: ETJ7Z6XBU4
Emvita 16ACONITUM NAPELLUS, AMBRA GRISEA, ESCHSCHOLTZIA, SECALE, THYMUS GLAND, ZINC METRUBIMED AGb681ec83-cc7f-4c8e-80a8-0aa0b1cc07592024-10-29WarningsExact identifier
unii: J41CSQ7QDS
Emvita 11CUPRUM MET, FERRUM MET, IGNATIA AMARA, PANCREAS, SECALERUBIMED AGae12f303-b388-47b2-9351-5bdc08f42fae2024-10-29WarningsExact identifier
unii: 789U1901C5
Emvita 15APIS MELLIFICA, LACHESIS MUTUS, PHOSPHORUS, THYMUS GLAND, ZINC METRUBIMED AG5467725e-814a-4b44-84c9-b89f70f017af2024-10-29WarningsExact identifier
unii: J41CSQ7QDS
Emvita 19CALCAREA CARBONICA, HYPOPHYSIS, MAG CARB, ZINC METRUBIMED AG90529540-7d82-47ba-8821-1ab2712610b92024-10-29WarningsExact identifier
unii: J41CSQ7QDS
Emvita 23AGARICUS MUSCARIUS, CUPRUM MET, HYPOPHYSIS, RHUS TOXRUBIMED AG010a76a8-da24-4dd1-9005-c0c2d25526f52024-10-29WarningsExact identifier
unii: 789U1901C5
Emvita 18AGARICUS MUSCARIUS, BUFO RANA, CUPRUM MET, THYROIDINUM, IODIUMRUBIMED AGce1d02fc-8e6d-4893-875f-bb10e74665202024-10-29WarningsExact identifier
unii: 789U1901C5
Emvita 5BUFO RANA, CUPRUM METALLICUM, GLANDULA SUPRARENALIS, PHOSPHORUS, PULSATILLA, ZINCUM METALLICUMRUBIMED AG2a141ded-a864-422f-8eb4-69d65fb59c152024-10-29WarningsExact identifier
unii: 789U1901C5
unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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