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 10 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOJO Antibacterial Plum Foam HandwashBENZALKONIUM CHLORIDEGOJO Industries, LLCa485a02f-0f6a-45b2-af5b-f690e02637ec2026-07-10WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand Wipes Lil Drug StoreBENZALKONIUM CHLORIDELil' Drug Store Products, Inc.6ab0488c-02f3-4aa6-b6b3-d4f0d582b1672026-07-10WarningsExact identifier
unii: F5UM2KM3W7
PURELL HEALTHY SP 0.5pct BAK Antimicrobial FoamBENZALKONIUM CHLORIDEGOJO Industries, LLC97b7d732-3b33-4c60-b6d9-0f1d28dda4bf2026-07-09WarningsExact identifier
unii: F5UM2KM3W7
Tobramycin Inhalation SolutionTOBRAMYCIN INHALATION SOLUTIONNorthStar RxLLC3d044738-a715-fdee-7849-521e8981e6ec2026-07-09Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
unii: F5UM2KM3W7
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
unii: F5UM2KM3W7
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 309683
unii: VZ8RRZ51VK
unii: 7S5I7G3JQL
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
BAK 1 750BENZALKONIUM CHLORIDEMedical Chemical Corporationd1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca82026-07-02WarningsExact identifier
unii: F5UM2KM3W7
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 0YPR65R21J
unii: 451W47IQ8X
ANTISEPTIC WIPEBENZALKONIUM CHLORIDE WIPEDiamond Wipes International0a49c713-56da-af45-e063-6394a90a8fce2026-07-01WarningsExact identifier
unii: F5UM2KM3W7
Laura Lynn Foaming Fragrance and Dye Free Antibacterial HandBENZALKONIUM CHLORIDEIngles Markets, Inc.57e83a97-5b5f-8034-e063-6394a90a42a62026-07-01WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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