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 112 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hygiene Clean Bubble Gum Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569875e-7a3d-17db-e053-2a95a90a3c2b2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Mahogany Teakwood Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5696369-175a-8add-e053-2995a90a5be82023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e8085d-8ab2-42c5-e053-2995a90aab372023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Luxury Clean Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda8fb1b-890e-b5c3-e053-2995a90a7b992023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Simple Hygiene Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INCb6fdf78f-4b9b-aca7-e053-2995a90a991c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lavender Blossom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe34df37-d0ee-8d6a-e053-2a95a90aa2b52023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77b4d-00b7-5c66-e053-2a95a90aa1742023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Sugar Hand Sanitizer on the go and car safeBENZALKONIUM CHLORIDEUSA Broom LLCbbb44ec3-82ba-7053-e053-2995a90a69452023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INC0ebf85c5-21ee-4d14-b88f-d8c078791aef2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Vanilla Woods Hand Sanitizer Car Safe Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCbafee8b1-2b06-48c0-e053-2a95a90a72242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70f2b9-7a44-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffb0061-4347-7cd9-e053-2995a90ac1142023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Leather Oak Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5693dee-c75c-08b5-e053-2995a90a43902023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda861a1-2e25-528c-e053-2a95a90a985e2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569b768-319b-89a0-e053-2a95a90af9012023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e77184-b325-6673-e053-2995a90a7d792023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Unscented Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffc6874-b7c6-726b-e053-2995a90a8b0f2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Spring Bloom Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe35349b-0f26-fa75-e053-2995a90a3b242023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCb2e7d11b-c5bf-5c00-e053-2a95a90a4bbc2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Blueberry Lemonade Hand Sanitizer Car Safe Alcohol-FreeBENZALKONIUM CHLORIDEUSA Broom LLCbafefe97-7365-06b3-e053-2a95a90a33482023-10-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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