FDA.reportPublic FDA data

NDC 59399-162 - Artificial Tears

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
59399-162
Package NDCs from labels
59399-162-35
Manufacturer
Akorn | Croda Europe Ltd.
Effective date
2022-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Artificial Tears - Akorn | Croda Europe Ltd.Akorn | Croda Europe Ltd.2022-11-03OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59399-162-35Artificial Tears1 in 1 CARTONOINTMENT14
59399-162-35Artificial Tears3.5 g in 1 TUBEOINTMENT3.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59399-162ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN]42 package rows20221104_41199644-fa45-43e2-a056-24aed0fff745.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGPARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN ANIMAL HEALTH, INC.]1
PetrolatumACTIVE INGREDIENT4T6H12BN9UARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN ANIMAL HEALTH, INC.]1
Mineral OilACTIVE MOIETYT5L8T28FGPARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN ANIMAL HEALTH, INC.]1
PetrolatumACTIVE MOIETY4T6H12BN9UARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN ANIMAL HEALTH, INC.]1
LanolinINACTIVE INGREDIENT7EV65EAW6HARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [AKORN ANIMAL HEALTH, INC.]1

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 7 of 30 · 588 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panama Jack SPF 45 Flavorless Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack1b15c00b-0e78-4dbe-877c-de3941ffe76e2026-02-26WarningsExact identifier
unii: 4T6H12BN9U
Dermatool HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPapalo Group LLC4bc06f41-7733-ebd0-e063-6294a90af7a82026-02-26WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
unii: 4T6H12BN9U
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Petroleum Skin ProtectantWHITE PETROLATUMFamily Dollar Stores, Incac7da793-8a39-4b47-b075-a4c4820cadad2026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMFamily Dollar Stores, Inc7e64a424-afdb-4eb9-b6af-7b8123f1e2072026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Petroleum Skin ProtectantWHITE PETROLATUMH E Be6154e44-d7b2-429c-9bc7-5c064220d3fb2026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMH E Bff79e42c-da3f-4aec-acf4-cc26e10a1d082026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMH E B460802cc-c1b9-41cb-afe3-ca4078175efb2026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMH E B2dd85211-0840-4d0d-8ba7-ea6184a509422026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMMeijer, Inc.12867b23-b203-4bd7-af6d-efddeead26be2026-02-24Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Pure petroleumWHITE PETROLATUMBetter Living Brands, LLC75cb8f17-6ef2-403e-ab6e-d8e1e8168ec82026-02-23Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
WHITE PETROLATUMPETROLATUMSion Biotext Medical Ltd53ca3aeb-1d5d-4964-adb5-1cfa901642da2026-02-23WarningsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMBetter Living Brands, LLCba50f2b2-aff8-42cd-8af0-369060a901fb2026-02-23Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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