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 90 of 163 · 3,259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NiferexFERROUS ASPARTO GLYCINATE, IRON, ASCORBIC ACID, FOLIC ACID, CYANOCOBALAMIN, ZINC, AND SUCCINIC ACIDAvion Pharmaceuticals, LLCa38ff367-983b-42db-ae5e-c9f75f7ace132025-04-08Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
unii: J41CSQ7QDS
Bestmade Natural Products Silicea 8xSILICEABestmade Natural Products31e15fbf-2439-8d96-e063-6294a90a46ed2025-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
PMSANGELICA ARCHANGELICA, CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, HYPOTHALAMUS SUIS, MAGNESIUM GLUCONICUM DIHYDRICUM, OOPHORINUM (SUIS) PYRIDOXINUM HYDROCHLORICUM, BOVISTA, CUPRUM METALLICUM, SEPIA, ZINCUM METALLICUM, LACHESIS MUTUSBioActive Nutritional, Inc.85304d4f-78b9-499e-8e1d-9202d9cde33d2025-04-02WarningsExact identifier
unii: 789U1901C5
unii: J41CSQ7QDS
GYNTIMA ProbioticaLACTIC ACID, FOLIC ACID, SAGEFytofontana LLC31b83e91-bdd1-bdd1-e063-6394a90a16d72025-04-01WarningsExact identifier
unii: 935E97BOY8
JBA Collagen-Electrolyte MocktailVITAMIN C,THIAMIN,RIBOFLAVIN,NIACIN,VITAMIN B6,FOLATE,BIOTIN,PANTOTHENIC ACID,MAGNESIUM,ZINC,SODIUM,POTASSIUM,BOVINE COLLAGEN PEPTIDESAdvanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticalse0199be5-0c51-411a-a184-225c1e6e602f2025-03-31WarningsExact identifier
unii: 935E97BOY8
unii: KV2JZ1BI6Z
unii: J41CSQ7QDS
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products Silicea 6x Lactose-freeSILICEA ORGANIC CANE SUGARBestmade Natural Products2991ecbf-925e-00f3-e063-6294a90a37bf2025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM60CIMICIFUGAD6, DROSERAD6, FORMICA RUFAD6, FULIGOD6, INULA HELD6, KALI MURD6, LAPIS ALBUSD6, SILICEAD6Bestmade Natural Products29912fb7-8712-18d9-e063-6394a90a82f72025-03-25WarningsExact identifier
unii: ETJ7Z6XBU4
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01273e8c-aef0-d800-e063-6294a90abd492025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD01221d57-9eec-7e77-e063-6394a90a60422025-03-23WarningsExact identifier
unii: 15FIX9V2JP
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Blush 40mL SPF 50TITANIUM OXIDE, ZINC OXIDENAKED SUNDAYS PTY LTD0ce809a1-45fb-9d4d-e063-6294a90a26a22025-03-23WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products SiliceaSILICEABestmade Natural Productse9eadb4e-659b-dcae-e053-2995a90a0db72025-03-21WarningsExact identifier
unii: ETJ7Z6XBU4
Strovite One CapletsVITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEINExeltis USA, Inc.b9b71fa4-89c7-4f5b-8174-950649434ba52025-03-20Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
unii: 935E97BOY8
Vitafol Fe PlusDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.3927b074-d72a-4d8c-9f7e-15c42a8309452025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 25X51I8RD4
unii: 935E97BOY8

Reported adverse events (FAERS/openFDA)#

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