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 111 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElimiShield Home and Outdoor Moisturizing Hand SanitizerBENZALKONIUM CHLORIDEBryson Industries Inc.affeb47c-0e10-7f04-e053-2a95a90a4f1f2023-11-09WarningsExact identifier
unii: F5UM2KM3W7
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
unii: F5UM2KM3W7
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
unii: F5UM2KM3W7
Throat CareECHINACEA, ACONITUM NAP., APIS MEL., ARUM DRAC., BELLADONNA, BRYONIA, CAJUPUTUM, FERRUM PHOS., GLYCYRRHIZA, KALI BIC., LACHESIS, MENTA PIP., MERC. VIV., NAJA, NAT. CARB., NAT SULPHURICUM, NITRICUM AC., NUX VOM., PHOS., PHYTOLACCA, PULSATILLA, SPONGIA, STANNUM MET., STICTA, THUJA OCC., ULMUS FULV., VERBASCUMNewton Laboratories, Inc.99eb7b5d-926d-aa16-e053-2a95a90a08342023-11-07WarningsExact identifier
unii: 0YPR65R21J
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Wet WipesBENZALKONIUM CHLORIDEZhejiang Ayan Biotech Co.,Ltd.21b48552-e624-455c-938f-8151e58d80e02023-11-06WarningsExact identifier
unii: F5UM2KM3W7
TRI-SOFT SOFTENINGBENZALKONIUM CHLORIDEClinical Therapeutic Solutions3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb2023-11-05WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEA-S Medication Solutions0d273133-0ce9-4fe6-b873-7f85aac254862023-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TobramycinTOBRAMYCINBausch & Lomb Incorporateda5693ec9-d2f7-4d45-90b0-a113c54840d72023-11-01Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
TobramycinTOBRAMYCINTeva Pharmaceuticals USA, Inc.c5f65e5b-c851-45da-a0e8-215d9a4e6ad32023-10-31Warnings, Adverse reactionsExact identifier
unii: VZ8RRZ51VK
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
Hygiene Clean Unscented Clean Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb569c604-7ba2-88e5-e053-2a95a90a9a0c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Balsam Fir Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb56a0275-1650-23a8-e053-2995a90a791c2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffbcf06-4b52-e38d-e053-2995a90a5dbf2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lilac Garden Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbe3527ae-ed2c-6b75-e053-2a95a90ab6ff2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Eucalyptus Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCbda8ccbb-f771-d897-e053-2995a90ada2a2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol FreeBENZALKONIUM CHLORIDEUSA Broom LLCba70e7cf-af9c-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Luxury Clean hand Sanitizer on the go and car safeBENZALKONIUM CHLORIDEUSA Broom LLCbbb44d63-ac8e-0d39-e053-2a95a90a319a2023-10-28WarningsExact identifier
unii: F5UM2KM3W7
Hygiene Clean Blueberry Lemonade Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCb5690e19-4f92-d667-e053-2995a90abd242023-10-28WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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