FDA.reportPublic FDA data

NDC 68071-4375-05 - Neomycin Polymyxin B Sulfates and Dexamethasone

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
68071-4375
Requested NDC
68071-4375-05
Package NDCs from labels
68071-4375-5, 68071-4375-05
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Polymyxin B Sulfates and Dexamethasone - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-15Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2023-01-30Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-02-16Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-01-29Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4375-5Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4375NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240608_691bc5ca-5d61-60c2-e053-2991aa0abb93.zip

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 84 of 134 · 2,662 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Base Laboratories SalineSODIUM CHLORIDEJoonem LLC9d83f477-ebbc-4248-8445-769178181d4f2024-12-23WarningsExact identifier
unii: 451W47IQ8X
FOOT WORKS MAXIMUM CRACKED HEELBENZALKONIUM CHLORIDE, LIDOCAINECOSMAX USA, CORPORATION29f92230-d1d4-5e94-e063-6294a90af8122024-12-23WarningsExact identifier
unii: F5UM2KM3W7
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
ARRAY Plum Scent Antibacterial Foam HandwashBENZALKONIUM CHLORIDEGordon Food Service, Inc.62ef137b-a2fe-4379-9d82-ff6b59667b7e2024-12-20WarningsExact identifier
unii: F5UM2KM3W7
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
AgroBac Pure FOAMBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.8b70a920-e63a-418f-8b79-f57eb5576b1a2024-12-20WarningsExact identifier
unii: F5UM2KM3W7
Oral Gel Oral Pain ReliefBENZOCAINE BENZALKONIUM CHLORIDESavvy Care and Cosmetics05ede7e4-5a0a-c942-e063-6294a90a8a242024-12-19WarningsExact identifier
unii: F5UM2KM3W7
AFFEX Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEAfflink, Inc.3f51700a-0e8f-4091-ab0d-6751364304a42024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE Antibacterial Foam HandwashBENZALKONIUM CHLORIDEBUNZLeb626be7-baec-447c-97e1-534494beb0202024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE SELECT Plum Antibacterial Foam Hand So apBENZALKONIUM CHLORIDEBUNZLd56dbf55-9630-4d00-9dc5-68e55f48e7932024-12-19WarningsExact identifier
unii: F5UM2KM3W7
DON Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEEdward Don & Company5b6852cd-b45a-4262-b454-041f223fa3f82024-12-19WarningsExact identifier
unii: F5UM2KM3W7
PRIME SOURCE ULTRA Energy Plum Antibacterial Foam Hand So apBENZALKONIUM CHLORIDEBUNZLfdb354e7-564f-4b0e-8bb7-7895521988182024-12-19WarningsExact identifier
unii: F5UM2KM3W7
RENOWN Antibacterial Plum HandwashBENZALKONIUM CHLORIDEInterline Brands, Inc.2b876c51-358a-4bb2-8f35-317ed7af47402024-12-19WarningsExact identifier
unii: F5UM2KM3W7
Victoria Bay Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEDade Paper & Bag, LLC51d05dca-ffe4-4f1c-a883-43c436dbf7402024-12-19WarningsExact identifier
unii: F5UM2KM3W7
BRIGHT SOLUTIONS Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEKel-San, Inc.844a80f3-9fd5-4688-81c8-494eb11a024a2024-12-19WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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