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 18 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HandsoapBENZALKONIUM CHLORIDETopco Associates LLCe60ff14a-f78d-c9fa-e053-2995a90a7f102026-05-05WarningsExact identifier
unii: F5UM2KM3W7
Kroger Springwater AntibacterialBENZALKONIUM CHLORIDEKroger Company01006967-d11c-d02a-e063-6394a90ad42c2026-05-04WarningsExact identifier
unii: F5UM2KM3W7
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
unii: F5UM2KM3W7
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
unii: F5UM2KM3W7
Winco FoodsBENZALKONIUM CHLORIDEWinCo Foods, LLCc98648f2-c6a4-64d9-e053-2995a90aa3522026-05-03WarningsExact identifier
unii: F5UM2KM3W7
Careone AmberBENZALKONIUM CHLORIDERetail Business Services, LLCcb8fdf26-8372-70d8-e053-2995a90a840a2026-05-03WarningsExact identifier
unii: F5UM2KM3W7
WalgreenBENZALKONIUM CHLORIDEWalgreen Coc992cf19-786c-d794-e053-2995a90af0672026-05-02WarningsExact identifier
unii: F5UM2KM3W7
WalgreenBENZALKONIUM CHLORIDEWalgreenead9641b-4d30-da10-e053-2995a90a60e72026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger AntibacterialBENZALKONIUM CHLORIDEKroger Company00ffe9f9-15c3-be46-e063-6394a90a3d352026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger Antibacterial LHSBENZALKONIUM CHLORIDEKroger Company0100d627-88e7-a80c-e063-6394a90a47972026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Kroger AntibacterialBENZALKONIUM CHLORIDEKroger Company0100f324-0204-3aba-e063-6394a90a46932026-05-02WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS PHARMACY, INCe584a181-1226-5dda-e053-2a95a90ab6452026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care0970a4e2-c7b5-bcb7-e063-6394a90a43532026-05-02WarningsExact identifier
unii: F5UM2KM3W7
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
unii: F5UM2KM3W7
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Summit 377Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDER.L. Williams Company50ae9765-2c2b-137f-e063-6294a90ae13a2026-04-30WarningsExact identifier
unii: F5UM2KM3W7
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Vita Vie Antibacterial WashBENZALKONIUM CHLORIDESpa De Soleila83883b7-9b63-641b-e053-2995a90ab9432026-04-30WarningsExact identifier
unii: F5UM2KM3W7
Dr Lift Advanced Antibacterial WipesBENZALKONIUM CHLORIDESpa de Soleilaf89bd25-784e-4828-e053-2995a90a8aaa2026-04-30WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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