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 21 of 30 · 588 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A and D Diaper Rash and Skin ProtectantLANOLIN AND PETROLATUMNatureplex LLCfcaf27c9-3634-4fb7-a311-2e093f0552782024-12-31WarningsExact identifier
unii: 7EV65EAW6H
unii: 4T6H12BN9U
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
unii: 4T6H12BN9U
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
unii: T5L8T28FGP
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
unii: 4T6H12BN9U
CUREFINIPETROLATUM, COD LIVER OILMiramar Cosmetics, Inc DBA Miramar Labfc9211db-71aa-44d8-a00b-65f1482d39812024-12-23WarningsExact identifier
unii: 4T6H12BN9U
CUREFINIPETROLATUMMiramar Cosmetics, Inc DBA Miramar Lab6a2610ca-ca80-451f-8fed-b982443a10b92024-12-23WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC453dffec-de9d-0eac-e054-00144ff8d46c2024-12-20WarningsExact identifier
unii: 7EV65EAW6H
unii: 4T6H12BN9U
Vitamin A and DLANOLIN, PETROLATUMTrifecta Pharmaceuticals USA LLC455a16fd-9ce5-6bef-e054-00144ff88e882024-12-20WarningsExact identifier
unii: 7EV65EAW6H
unii: 4T6H12BN9U
White PetrolatumPETROLATUMTrifecta Pharmaceuticals USA LLCf1eb0ec2-98e7-13a2-e053-2a95a90a29382024-12-20WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
White Rain Original PetroleumWHITE PETROLEUMINTERNATIONAL WHOLESALE INC.d6ebe00c-b692-5171-e053-2a95a90a976c2024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Health Smart Original PetroleumWHITE PETROLEUMHome Smart Productsaedf746f-4c49-421d-a666-1ba02e8fb17d2024-12-19WarningsExact identifier
unii: 4T6H12BN9U
white rain Cocoa Butter Petroleum JellyWHITE PETROLATUMINTERNATIONAL WHOLESALE INC.d7068e2b-c3b2-d16d-e053-2a95a90a6dd22024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Health Smart Lavender Baby PetroleumWHITE PETROLEUMHome Smart Products5828df37-2a42-4129-8e4e-d5ac9c4c96152024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyWHITE PETROLATUMRejoice International Inc.980d030a-feaf-4a81-865e-f85c661513802024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Baby Petroleum JellyWHITE PETROLATUMRejoice International Inc.caf568aa-3889-41ff-835e-875bb6d9ca792024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Petroleum JellyWHITE PETROLATUMRejoice International Inc.a45eb8aa-9fc9-4332-a3ef-0e6fd348fb952024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Cars PetroleumWHITE PETROLATUMUltra Distributors Inc.9905b5a4-382e-4d2a-b971-37998c14c3302024-12-19WarningsExact identifier
unii: 4T6H12BN9U
Health Smart Aloe Vera PetroleumWHITE PETROLEUMHome Smart Products2671f2ed-af9d-4234-95bf-def368242a782024-12-19WarningsExact identifier
unii: 4T6H12BN9U
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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