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 2 of 113 · 2,247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Swisher Advanced Antibacterial Foam HandsoapBENZALKONIUM CHLORIDEEcolab Inc.38bd6680-db95-424c-8e84-2e12c2388a732026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a28101f-ea8e-6071-e063-6294a90aad912026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a3e62ce-52dc-121b-e063-6294a90a898f2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a49db18-c270-6f46-e063-6294a90afb5d2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4ac18e-8ba5-bef6-e063-6394a90a88112026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.5a4d11fa-3f65-b41f-e063-6394a90a30ae2026-08-31WarningsExact identifier
unii: F5UM2KM3W7
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
unii: F5UM2KM3W7
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59ed87d5-dab1-abab-e063-6394a90a024d2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
unii: F5UM2KM3W7
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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