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 55 of 163 · 3,259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
unii: 15FIX9V2JP
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
unii: 15FIX9V2JP
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
unii: 15FIX9V2JP
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf36c1-50c9-e848-e063-6294a90a66582025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Invisible StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d2489e-4978-4fc3-e063-6294a90adfcc2025-12-15Exact identifier
unii: 15FIX9V2JP
Flash Tinted StickTITANIUM DIOXIDE, ZINC OXIDEAEON AESTHETICS LLC35d28590-e746-7996-e063-6294a90ac7d82025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf03f4-200a-5643-e063-6394a90a9e022025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d9d83b-7da7-a006-e063-6394a90a9d842025-12-15Exact identifier
unii: 15FIX9V2JP
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN & ACNE36d3ebc0-1de6-1998-e063-6294a90a02e62025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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