FDA.reportPublic FDA data

NDC 59399-160 - 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
59399-160
Package NDCs from labels
59399-160-15
Manufacturer
Akorn | Avantor Performance Materials International, Inc.
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 | Avantor Performance Materials International, Inc.Akorn | Avantor Performance Materials International, Inc.2022-11-03OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59399-160-15Artificial Tears1 in 1 CARTONSOLUTION/ DROPS15
59399-160-15Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59399-160ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN]52 package rows20221104_2ef16864-97cb-4dfe-9461-cba156144c69.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Polyvinyl AlcoholACTIVE INGREDIENT532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Polyvinyl AlcoholACTIVE MOIETY532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium Phosphate, Dibasic, AnhydrousINACTIVE INGREDIENT22ADO53M6FARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
Sodium Phosphate, Monobasic, AnhydrousINACTIVE INGREDIENTKH7I04HPUUARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [AKORN ANIMAL HEALTH, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [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 49 of 109 · 2,170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROHEAL BENZALKONIUM CHLORIDE ANTISEPTIC TOWELETTESBENZALKONIUM CHLORIDEClick Industries LLCa1f80f47-f225-4132-b75d-1427fc2b3b662025-10-28WarningsExact identifier
unii: F5UM2KM3W7
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CompleteBENZALKONIUM CHLORIDESimoniz Saniclean, LLC41ed32ea-5a3b-fa50-e063-6394a90a20c42025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
unii: F5UM2KM3W7
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
unii: F5UM2KM3W7
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: 532B59J990
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
unii: F5UM2KM3W7
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
United AirlinesBENZALKONIUM CHLORIDEFreshorize Ltda8d96b43-272a-9e49-e053-2995a90a3cc12025-10-23WarningsExact identifier
unii: F5UM2KM3W7
WastedBENZALKONIUM CHLORIDEFreshorize Ltd0c43b516-7608-c826-e063-6294a90ae4e32025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Alaska AirlinesBENZALKONIUM CHLORIDEFreshorize Ltd.a8ed793e-988e-d815-e053-2995a90a3d312025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Sani-Foam Foaming Non-Alcohol Hand SanitizerBENZALKONIUM CHLORIDEMulti-Clean2bea7ec7-e79e-8f34-e063-6294a90a96092025-10-23WarningsExact identifier
unii: F5UM2KM3W7
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
ANTISEPTIC WIPEBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.3a40a31d-4032-71ba-e063-6294a90a48dc2025-10-19WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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