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 118 of 160 · 3,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.09d87efd-9ae3-45ea-8bb6-3e507ae31cfb2024-07-29WarningsExact identifier
unii: J41CSQ7QDS
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
unii: 15FIX9V2JP
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.4080fcfb-7ef2-45f5-8c3b-592d3b66a1202024-07-29WarningsExact identifier
unii: J41CSQ7QDS
CirculationNIACIN, NICOTINAMIDUM, ARNICA MONTANA, CAMPHORA, NUX VOMICA, VERATRUM ALBUM, ADRENALINUM, AESCULUS HIPPOCASTANUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HELODERMA (HORRIDUS), RHUS TOX, TABACUMNutritional Specialties, Inc.f8b51780-1644-477a-a3e4-5798c28bedfc2024-07-24WarningsExact identifier
unii: 25X51I8RD4
Pineal LiquescenceVALERIANA OFFICINALIS, HYDROCOTYLE ASIATICA, MELATONIN, CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), SCUTELLARIA LATERIFLORA, STELLARIA MEDIA, CALCAREA CARBONICA, ZINCUM METALLICUM, AURUM METALLICUM, DOPAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), MAGNESIA MURIATICANutritional Specialties, Inc.ccaf3166-5e2f-4c7f-80a8-ee722bdf0c5b2024-07-24WarningsExact identifier
unii: J41CSQ7QDS
Pineal LiquescenceVALERIANA OFFICINALIS, HYDROCOTYLE ASIATICA, MELATONIN, STELLARIA MEDIA, CEREBRUM SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), SCUTELLARIA LATERIFLORA, CALCAREA CARBONICA, ZINCUM METALLICUM, DOPAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), MAGNESIUM METALLICUMNutritional Specialties, Inc.9f2454ad-d26a-4c07-8842-d92b51fd144e2024-07-24WarningsExact identifier
unii: J41CSQ7QDS
Folic AcidFOLIC ACIDA-S Medication Solutions16f8a1a1-ee81-4cd3-85e7-e1eae83fad672024-07-22Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Folic AcidFOLIC ACIDA-S Medication Solutionsb48f4a4e-ece7-4bbb-b659-ed446cd9f0c92024-07-22Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
unii: 15FIX9V2JP
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1ce8c1da-565d-5487-e063-6294a90a1bde2024-07-10WarningsExact identifier
unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1cc19337-cf54-af5d-e063-6394a90a1ceb2024-07-08WarningsExact identifier
unii: 15FIX9V2JP
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAYEnergique, Inc.c3d2fd24-6b41-4c85-bd5f-c3306e97080e2024-07-03WarningsExact identifier
unii: 789U1901C5
unii: ETJ7Z6XBU4
PMSAPIS MELLIFICA, CHAMOMILLA, CIMICIFUGA RACEMOSA, CUPRUM METALLICUM, IGNATIA AMARA, KALI IODATUM, MAGNESIA PHOSPHORICA, OOPHORINUM (SUIS), PLATINUM METALLICUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.575b4736-5bae-4f15-b55b-3e1fbbb613ff2024-07-01WarningsExact identifier
unii: 789U1901C5
Cough plus BronchialANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENSLiddell Laboratories, Inc.801eba42-4217-46e9-8f3e-745da01a27b02024-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
unii: 15FIX9V2JP
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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