FDA.reportPublic FDA data

NDC 42783-510 - NicAzelFORTE

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
42783-510
Package NDCs from labels
42783-510-60, 42783-510-04
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
NicAzelFORTE - Elorac, IncElorac, Inc2021-12-08DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-510-04NicAzelFORTE4 in 1 BOTTLETABLET425
42783-510-60NicAzelFORTE60 in 1 BOTTLETABLET6025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-510NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]252 package rows20211209_bea888b4-9cc6-49da-89e6-5c273b974ed1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42783-510-60EA - Each42783-510c10f4b12-e96f-49d6-b7f2-2e29cf0c7d4012014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CUPRIC OXIDEACTIVE INGREDIENTV1XJQ704R4NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
FOLIC ACIDACTIVE INGREDIENT935E97BOY8NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
PYRIDOXINEACTIVE INGREDIENTKV2JZ1BI6ZNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
CUPRIC CATIONACTIVE MOIETY8CBV67279LNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
FOLIC ACIDACTIVE MOIETY935E97BOY8NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
ZINC CATIONACTIVE MOIETY13S1S8SF37NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNICAZELFORTE (AZERIZIN, PYRIDOXINE, ZINC, COPPER, FOLIC ACID) TABLET [ELORAC, INC]5

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 46 of 278 · 5,547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: SOI2LOH54Z
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDETarget Corporation8059f489-f144-4de5-9454-ac6c1af35dd22026-02-18Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Dermatone Mineral SPF 30ZINC OXIDE 20%Dermatone Labs LLC26e3209f-cb5c-484e-9b2e-74dc397d47902026-02-18WarningsExact identifier
unii: SOI2LOH54Z
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
unii: SOI2LOH54Z
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
unii: SOI2LOH54Z
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
unii: SOI2LOH54Z
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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