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 71 of 275 · 5,482 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc0806bdb9-961f-3146-e063-6294a90a46252025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Pure and Simple Baby Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc088b7152-d3d1-9e74-e063-6394a90a41522025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47461ad3-a11e-2a11-e063-6294a90a0f8f2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Inc081484f8-58f5-f2a4-e063-6394a90a33792025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Pure and Simple Kids Sunscreen SPF 50ZINC OXIDE (24.08%)Beiersdorf Inc09a97e3f-f6dc-eaa7-e063-6294a90ad2742025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Kids Roll-On Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incf3e1ea21-4a07-3e18-e053-2995a90a0fe72025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Eucerin Sensitive Mineral Face Sunscreen SPF 35ZINC OXIDE 24%Beiersdorf Incf3a8bb6b-f051-5d39-e053-2a95a90adafc2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Defend and ClearOCTINOXATE, OCTISALATE, ZINC OXIDEBeiersdorf Incbaaec6a9-2c60-2d11-e053-2a95a90abca72025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incb6492438-5dd2-030e-e053-2a95a90a2f9f2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb6861830-fdad-3829-e053-2a95a90a09712025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Kids Tear Free Mineral Sunscreen SPF 50OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%Beiersdorf Incc054fd86-b0d9-24fc-e053-2a95a90aea2c2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Coppertone Sunscreen SPF 50ZINC OXIDE 20%Beiersdorf Incd46359e7-b585-c43a-e053-2995a90a08632025-12-31WarningsExact identifier
unii: SOI2LOH54Z
Sei Bella CC Brightening Creme LightOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6894b9d9-a5b5-4c98-e053-2991aa0a9ca22025-12-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme FairOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.6892952a-d032-30bf-e053-2a91aa0a3bba2025-12-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium TanOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4e8b4-36cb-6306-e053-2a91aa0a6d252025-12-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
Sei Bella CC Brightening Creme MediumOCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%Melaleuca Inc.68a4ed34-f492-67a6-e053-2a91aa0a04282025-12-31WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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