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 14 of 113 · 2,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
Caring Mill BZK TowelettesBENZALKONIUM CHLORIDEFSA Store Inc.51f20e04-3efb-9dbf-e063-6394a90a4aca2026-05-18WarningsExact identifier
unii: F5UM2KM3W7
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
Orajel Cold Sore Touch Free - Single DoseBENZALKONIUM CHLORIDE, BENZOCAINEChurch & Dwight Co., Inc.ce40829e-941f-2548-e053-2995a90a1e0e2026-05-13WarningsExact identifier
unii: F5UM2KM3W7
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
Lightning X BZK WIPEBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.5182df99-d825-376e-e063-6394a90a54352026-05-11WarningsExact identifier
unii: F5UM2KM3W7
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
tazza ECOFIT WIPESBENZALKONIUM CHLORIDETazza Brands East Inc50a83324-cc13-3668-e063-6394a90a44ed2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
unii: F5UM2KM3W7
crisp pearBENZALKONIUM CHLORIDELIDL US LLCca58d78e-a85a-da96-e053-2995a90a60a92026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HIMarkBENZALKONIUM CHLORIDEApollo Health and Beauty Caref96022c6-268b-9085-e053-6294a90a0e3f2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Better Living BrandsBENZALKONIUM CHLORIDEBetter Living Brands LLCee53ceaf-8709-459b-e053-2995a90a05e02026-05-08WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacye56e908d-a372-5f3a-e053-2a95a90ac5f62026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Gold LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care1e1459c8-0c8a-0e40-e063-6294a90a53742026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify White Tea LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d72396-2aeb-f8f3-e063-6394a90a9ec82026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Simplify Crisp Clean LHSBENZALKONIUM CHLORIDERITE AID CORPORATION20d75a2f-8b82-924c-e063-6294a90ae09c2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One RegularBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25a7fc33-4d6a-3a67-e063-6294a90a44652026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Crisp CleanBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b33a18-0b14-5411-e063-6294a90a31ee2026-05-08WarningsExact identifier
unii: F5UM2KM3W7
Care One Fresh CitrusBENZALKONIUM CHLORIDERETAIL BUSINESS SERVICES , LLC25b338fc-8f03-5eb6-e063-6294a90aacc52026-05-08WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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