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 34 of 278 · 5,547 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDAmneal Pharmaceuticals of New York LLCfd85395e-6a0b-4072-a80b-36095c0c6dd62026-04-15Warnings, Adverse reactionsExact identifier
unii: 935E97BOY8
MELAO Hydrating Mineral SunscreenTITANIUM DIOXIDE,ZINC OXIDEGuangdong Aimu Biological Technology Co., Ltd4f778eb0-55f7-38d0-e063-6394a90a69a02026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f81e482-8111-451c-e063-6294a90ad1482026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f8353b3-4ac1-9703-e063-6294a90abdad2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f83dd76-a8d8-916e-e063-6294a90ab6ed2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Sunscreen Stick - TintedTITANIUM DIOXIDE, ZINC OXIDEUNDRBUDR, LLC4f84619f-3415-7443-e063-6394a90a162a2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen IvoryTITANIUM DIOXIDE AND ZINC OXIDEPML NYC, LLC1be639a8-179a-7015-e063-6394a90ab64b2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30PML NYC, LLCea90bb4d-6f4a-45c9-e053-2a95a90a53a72026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
unii: SOI2LOH54Z
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTERYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e24a63e-d76f-6581-e063-6394a90a61812026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream115 NPML NYC, LLC316e8ac6-f8fa-7add-e063-6294a90a4f242026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f87e24f-e4ff-03a7-e063-6294a90a23b12026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo GlowYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd602-8af5-fbb6-e063-6294a90a287b2026-04-15WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Chanvida Broad Spectrum BB CreamCHANVIDA BROAD SPECTRUM BB CREAMGuangzhou Ariel Biotech Co., Ltd.4f8ade09-4f7a-80bd-e063-6394a90a08432026-04-15WarningsExact identifier
unii: SOI2LOH54Z
PRENATE EnhanceASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLCcf10de09-6ed5-4a66-84fa-2da4f668bbe62026-04-14Boxed warning, Adverse reactionsExact identifier
unii: 935E97BOY8
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERBEAUTY PIE U.S.A. INC.fdefb670-510c-9f1f-e053-6394a90a6a162026-04-14WarningsExact identifier
unii: SOI2LOH54Z
DAILY SUPERGOOP DOSE BIORETINOL MINERAL SPF 40DAILY DOSE BIORETINOL MINERAL SPF 40PML NYC, LLC05574910-ddf9-b138-e063-6394a90adc8c2026-04-14WarningsExact identifier
unii: SOI2LOH54Z
ProtecTINT 20CHOMOSALATE, OCTISALATE, ZINC OXIDEPML NYC, LLC1bcc9f71-820f-eba2-e063-6394a90a33052026-04-14WarningsExact identifier
unii: SOI2LOH54Z
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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