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 29 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Whispering RoseBENZALKONIUM CHLORIDER & R Lotion, Inc4a93b67c-7edc-28ad-e063-6394a90a1ac22026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Wet wipesBENZALKONIUM CHLORIDEZhejiang Easyclean Daily Chemical Co., Ltd.a1cb6ac9-95f5-3ef1-e053-2a95a90abcdf2026-02-11WarningsExact identifier
unii: F5UM2KM3W7
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
DEXAMETHASONEDEXAMETHASONENuCare Pharmaceuticals, Inc.4a808dd5-35b7-e879-e063-6394a90a0bf72026-02-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
tobramycinTOBRAMYCINSlate Run Pharmaceuticals, LLCed254eec-10f4-425a-895b-66e325b7bf692026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.49e31509-d489-44be-e063-6394a90a97ef2026-02-10WarningsExact identifier
unii: F5UM2KM3W7
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAMBENZALKONIUM CL 0.13% V/VMY IMPORTS USA LLC4a849c4f-9b96-6b20-e063-6394a90a34862026-02-10WarningsExact identifier
unii: F5UM2KM3W7
Everlit Care Products Antiseptic WipeANTISEPTIC WIPEEVERLIT GLOBAL INC.3331e2f1-c3d0-41fc-a792-be5dcdf4e24a2026-02-09WarningsExact identifier
unii: F5UM2KM3W7
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: 0YPR65R21J
DexamethasoneDEXAMETHASONEDirect_Rx0a0db8e7-8474-3d08-e063-6294a90af3f52026-02-06Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.3803d8d6-ed43-4dcf-ba04-92914bfa5e9a2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Antibacterial Foaming Hand WashBENZALKONIUM CHLORIDESalado Sales Inc.b56aefb5-7134-44dd-b341-b9a3515db35e2026-02-06Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke830be9d-0a8c-4712-93c6-284c208d6f0d2026-02-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Aquarrelle Antibacterial Wipes 40BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.3584680e-71b0-23b6-e063-6294a90a69982026-02-05WarningsExact identifier
unii: F5UM2KM3W7
Aquarrelle Antibacterial Wipes 20BENZALKONIUM CHLORIDEKimberly-Clark De Mexico, S.A.B.deC.V.35865d33-a99f-1b37-e063-6394a90a00d22026-02-05WarningsExact identifier
unii: F5UM2KM3W7
TobramycinTOBRAMYCINSportpharm LLC6ded47a3-d5c0-4616-8b7d-d6d0e6bce2a02026-02-05Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Benzalkonium chlorideBENZALKONIUM CHLORIDEPharmacy Value Alliance, LLC5f9521f2-53f2-4d7e-9116-36e94e2d06952026-02-05Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
DexamethasoneDEXAMETHASONEBryant Ranch Prepackb3217057-5945-452c-aa99-ab696fd8b5e72026-02-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Zehn Antiseptic Sanitizing WipesBENZALKONIUM CHLORIDEZehn Wipes1c7bfc17-e552-1f51-e063-6394a90a24ac2026-02-04WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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