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 91 of 275 · 5,482 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35425e24-3e2c-51db-e063-6394a90a55802025-12-15Exact identifier
unii: SOI2LOH54Z
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396fe2ca-eb29-5952-e063-6294a90ab2792025-12-15Exact identifier
unii: SOI2LOH54Z
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396f91b3-3326-3239-e063-6294a90a5df92025-12-15Exact identifier
unii: SOI2LOH54Z
Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35422370-eb55-049c-e063-6294a90ad0a42025-12-15Exact identifier
unii: SOI2LOH54Z
Eclipse Face TintedZINC OXIDEDENISE BELL SKIN CARE396f0151-2d0d-f4da-e063-6394a90a5f7f2025-12-15Exact identifier
unii: SOI2LOH54Z
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
unii: SOI2LOH54Z
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
unii: SOI2LOH54Z
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
unii: SOI2LOH54Z
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
unii: SOI2LOH54Z
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
unii: SOI2LOH54Z
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact identifier
unii: SOI2LOH54Z
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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