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 8 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrugStore Antibacterial Hand WipesBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.56b621f2-eeaf-6ff1-e063-6394a90a88292026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
unii: F5UM2KM3W7
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
unii: F5UM2KM3W7
ALTA ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEAlta Sales Inc9064a1b1-dd4a-4f74-99c4-5ea93b4be2102026-07-20WarningsExact identifier
unii: F5UM2KM3W7
Meijer Antibacterial Spring Rain HandBENZALKONIUM CHLORIDEMeijer, Inc.35bbdd67-6d15-26b6-e063-6394a90a3f962026-07-19WarningsExact identifier
unii: F5UM2KM3W7
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact identifier
unii: F5UM2KM3W7
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
DexamethasoneDEXAMETHASONESportpharm LLCa37486b9-4323-41fc-ac7e-869d95dc95682026-07-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDENANTONG HAIYIWEI TEXTILE CO., LTD.56cd55ee-b8ba-ddb9-e063-6394a90a1edc2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
FoamyiQ Non-Alcohol Hand SanitizerFOAMYIQ NON-ALCOHOL HAND SANITIZERSpartan Chemical Companyee8a2af2-0572-19b1-e053-2995a90a23ae2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Biodegradable Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Incd4e03834-d487-9f5d-e053-2a95a90a5e282026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Sanitizing Wipes Alcohol Free Fragrance FreeBENZALKONIUM CHLORIDEGoodEarth Distribution Llcd4de3289-5a00-5df4-e053-2995a90a9f3f2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEERC ACQUISITION, INC.00cd6f41-c9a8-b384-e063-6394a90a85752026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEGoodEarth Distribution Llcb92744a3-32aa-4aab-ab65-eba9a90e4c572026-07-17WarningsExact identifier
unii: F5UM2KM3W7
MaxSaver Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc00ccdb15-7db9-0102-e063-6294a90a3ee32026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Hand Sanitizing Wipes Fragrance FreeBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc9886fa20-65c7-4deb-a1ae-0c3e52ba887e2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Fragrance Free Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Ince805a12d-2bd8-4331-bd81-02c99d057acf2026-07-17WarningsExact identifier
unii: F5UM2KM3W7
Touchpoint Wipes Sanitizing WipesBENZALKONIUM CHLORIDEInnocore Sales & Marketing Inc0ed4dcb8-857d-4631-89c9-66052b1d46312026-07-17WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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