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 66 of 132 · 2,633 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
MenopauseANGELICA ARCHANGELICA, ARALIA QUINQUEFOLIA, CIMICIFUGA RACEMOSA, HYDRASTIS CANADENSIS, PULSATILLA, SABINA, SEPIA, SULPHURICUM ACIDUM, LACHESIS MUTUSBioActive Nutritional, Inc.03ce1f50-6af5-4640-825f-67fcb25e76e62025-06-24WarningsExact identifier
unii: O40UQP6WCF
fomin mini Hand Sanitizer Wipes MELON POPBENZALKONIUM CHLORIDEFomin LLC080b6b55-ba4b-46a6-bcc2-914f906e05912025-06-24WarningsExact identifier
unii: F5UM2KM3W7
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.38381a41-db33-45c6-e063-6394a90a23172025-06-23WarningsExact identifier
unii: F5UM2KM3W7
fomin mini Hand Sanitizer Wipes COCO-NILLA BLISSBENZALKONIUM CHLORIDEFomin LLC75a13584-a151-4fd4-a281-fec630801d652025-06-23WarningsExact identifier
unii: F5UM2KM3W7
fomin mini Hand Sanitizer Wipes FRAGRANCE FREEBENZALKONIUM CHLORIDEFomin LLC020f06c6-c76c-40fc-bc56-c11d5b389d672025-06-23WarningsExact identifier
unii: F5UM2KM3W7
Kindest Kare Advanced Antimicrobial Foam HandwashBENZALKONIUM CHLORIDESC Johnson Professional USA, Inc.9ea1175e-45aa-45c5-87a1-55d64cc37a882025-06-20WarningsExact identifier
unii: F5UM2KM3W7
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Cart Wipes Clean Sanitizing WipesBENZALKONIUM CHLORIDECarts and Parts INC.6a8433e8-7b96-44ce-b8e2-c60575898dab2025-06-18WarningsExact identifier
unii: F5UM2KM3W7
FoamFresh Alco-Free Hand SanitizerBENZALKONIUM CHLORIDEWoodbine Products Company59614a1a-6b76-45e7-8b57-af307a1673cf2025-06-17WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP32bc07dc-7a9c-63ed-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP33376694-fccd-6ed5-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3337b028-2291-0a1d-e054-00144ff88e882025-06-11WarningsExact identifier
unii: F5UM2KM3W7
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3338023a-171e-1e49-e054-00144ff8d46c2025-06-11WarningsExact identifier
unii: F5UM2KM3W7
Diabecin HRLIDOCAINE HCL, BENZALKONIUM CHLORIDEPureTek Corporation36c60fe2-5b7b-83dd-e063-6294a90ad4672025-06-10Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Algonquin HanClean FoamBENZALKONIUM CHLORIDEWhisk Products, Inc.aad3246e-0ef3-4fce-ae11-10a1b5197b192025-06-09WarningsExact identifier
unii: F5UM2KM3W7
Everywhere Flushable WipesEVERYWHERE FLUSHABLE WIPESShenzhen Shierjie Biological Engineering Co., LTD371be299-5aaf-b9d7-e063-6294a90a87f52025-06-08WarningsExact identifier
unii: F5UM2KM3W7
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
Zogics Foam Hand SanitizerBENZALAKONIUMZogics, LLC36e8b7a6-4e3b-378e-e063-6394a90a26522025-06-06WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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