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 52 of 109 · 2,170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProHeal BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.3ffc3f34-086d-1d18-e063-6294a90a71bb2025-09-29WarningsExact identifier
unii: F5UM2KM3W7
First Aid Direct Antiseptic WipeBENZALKONIUM CHLORIDECintas Corporationa23f3685-7213-4cc0-97b2-588fb12247922025-09-29WarningsExact identifier
unii: F5UM2KM3W7
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
unii: F5UM2KM3W7
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEAocai Biotechnology Huizhou Co Ltd3fa738ce-0a04-fa11-e063-6294a90aba882025-09-25WarningsExact identifier
unii: F5UM2KM3W7
EZ-448 Antibacterial Moist HandBENZALKONIUM CHLORIDEEz Products Of South Florida, LLC664ab52d-60e3-a8c8-e053-2a91aa0a7c402025-09-24WarningsExact identifier
unii: F5UM2KM3W7
Xpect AntisepticBENZALKONIUM CHLORIDECintas Corporationd9a31a11-e80f-4ded-ad0a-34f93b01557e2025-09-22WarningsExact identifier
unii: F5UM2KM3W7
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
MOONIES Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEHangzhou Chunchi Touring Commodity Co., Ltd.3eee1a5c-e926-5251-e063-6294a90a5d2e2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
MyTerra Hand Sanitizer Foam NABENZALKONIUM CHLORIDEPortionPac Chemical Corporation207ed8a6-b8db-43c9-9335-b313b16af9d52025-09-17WarningsExact identifier
unii: F5UM2KM3W7
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEGertex Hosierya182eafa-0ce0-4b99-bcb0-23f9a8de9e1f2025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC190d7d61-5ea9-6670-e063-6294a90a45352025-09-17WarningsExact identifier
unii: F5UM2KM3W7
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC231ba8dd-e827-bc79-e063-6394a90a75382025-09-17WarningsExact identifier
unii: F5UM2KM3W7
I.C. Waterless Hand Cleaner with Micro ScrubbersBENZALKONIUM CHLORIDER & R Lotion, Inca0bcc8a1-8bc6-4a42-b12d-ea1f3d9977a62025-09-15WarningsExact identifier
unii: F5UM2KM3W7
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: 532B59J990
Benzalkonium ChlorideANTIBACTERIAL WET WIPESDiamond Wipes International9296f7ad-eab9-4336-b0fa-8297a070fd182025-09-11WarningsExact identifier
unii: F5UM2KM3W7
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
I.C. Antibacterial Hand CleanerBENZALKONIUM CHLORIDER & R Lotion, Incafd59808-4ab7-4752-b358-6b21b5d4ad302025-09-10WarningsExact identifier
unii: F5UM2KM3W7
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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