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 20 of 30 · 588 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
unii: T5L8T28FGP
Hania Skin ProtectantPETROLATUMNatureplex LLC63609a57-91fc-4cfd-b942-b69a0d2fb2842025-02-19WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum JellyPETROLATUMRejoice International6b765967-aead-4f6d-98ee-fac381a40a6e2025-02-11WarningsExact identifier
unii: 4T6H12BN9U
XtraCare Creamy Petroleum JellyPETROLATUMRejoice Internationaldf367223-b004-42ac-ab3d-23809ebef1b02025-02-11WarningsExact identifier
unii: 4T6H12BN9U
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
unii: T5L8T28FGP
Geri-Gentle petrolatumWHITE PETROLATUMGeri-gentle corporation0adfbb9e-173c-925a-e063-6394a90aeb5d2025-01-25WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Royal Creamy Petroleum Jelly Cocoa ButterPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Careaca24d5e-42ee-1606-e053-2a95a90ab4e62025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Royal Creamy Petroleum JellyPETROLATUM JELLYMission Series Inc. dba Prestige Beauty Carea903becc-443d-284b-e053-2a95a90a6c752025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Pharmacys Prescription Petroleum JellyPETROLATUMAmerican Consumer Products Corpc4d29ecb-bb00-cb0b-e053-2995a90a37ef2025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
unii: 4T6H12BN9U
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
unii: 4T6H12BN9U
Sunmark Mineral Oil LaxativeMINERAL OILStrategic Sourcing Servicesc54f7df2-3845-425f-b13e-3dc000123f3c2025-01-14WarningsExact identifier
unii: T5L8T28FGP
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
unii: 7EV65EAW6H
unii: 4T6H12BN9U
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
unii: 4T6H12BN9U
unii: T5L8T28FGP
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: 4T6H12BN9U
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
unii: T5L8T28FGP
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A and DPETROLATUMTrifecta Pharmaceuticals USA LLCf1ea9640-4a6d-1c76-e053-2a95a90ad3b12024-12-31WarningsExact identifier
unii: 4T6H12BN9U
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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