FDA.reportPublic FDA data

NDC 80425-0366-01 - Tobramycin 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
80425-0366
Requested NDC
80425-0366-01
Package NDCs from labels
80425-0366-1, 80425-0366-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tobramycin and Dexamethasone - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0366-1Tobramycin and Dexamethasone5 mL in 1 BOTTLESUSPENSION/ DROPS52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0366TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 1 package rows20250101_09315f0b-f15a-30d5-e063-6394a90ac8dd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0366-1ML - Milliliter80425-0366dda8d509-96d2-4b7a-8923-64f4cf3c30e712023-12-05

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 28 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntibacterialBENZALKONIUM CHLORIDE 0.13%Uline57c7bf8f-c17a-41b5-9b66-e4d16d6650a72026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEULINE5a4d6fb7-486a-448c-b379-726adf60e4112026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WashBENZALKONIUM CHLORIDE 0.13%Uline9e7a97a0-f3dd-40cf-b25e-8ebb656939262026-02-17Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Foaming HandBENZALKONIUM CHLORIDEVeritiv Operating Company3b4dbfd0-f275-3502-e063-6294a90a84862026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEVeritiv Operating Company3b4f27c8-6a1c-2823-e063-6294a90a47ad2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Valu Merchandisers Companyfb9071d7-e44a-47fc-b76d-faf6220a57bf2026-02-16Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
unii: F5UM2KM3W7
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Wakefern Food Corp.d4e823bc-527b-4815-a7e0-47ee8d004e632026-02-13Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Ciprofloxacin and DexamethasoneCIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONEUpsher-Smith Laboratories, LLC9c5994d1-01d1-493c-a6ae-94754cd593892026-02-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Benzalkonium chlorideBENZALKONIUM CHLORIDE 0.13%Your Military Exchanges8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b2026-02-12Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Cucumber Mint BlissBENZALKONIUM CHLORIDER & R Lotion, Inc458dec24-b5bb-240a-e063-6294a90a81f32026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Vanilla Sugar BlissBENZALKONIUM CHLORIDER & R Lotion, Inc4a6b89dc-1c0a-61e2-e063-6294a90aeca82026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Island TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a7c2d9a-4bf1-d4a8-e063-6394a90ae1722026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand SanitizerBENZALKONIUM CHLORIDER & R Lotion, Inc3ba7408c-7165-448c-b31c-9890807c0cb92026-02-11WarningsExact identifier
unii: F5UM2KM3W7
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Eucalyptus TranquilityBENZALKONIUM CHLORIDER & R Lotion, Inc4a8243c4-969b-a123-e063-6394a90a342a2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDE 0.13%Medline Industries, LP3c56b4c2-42f5-66d7-e054-00144ff8d46c2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
CleanseBENZALKONIUM CHLORIDEMedline Industries, LP428644dd-b2e5-1675-e054-00144ff88e882026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Incc4328104-5a17-4673-925b-3d3206994e6e2026-02-11Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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