FDA.reportPublic FDA data

NDC 68071-4375-05 - Neomycin Polymyxin B Sulfates 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
68071-4375
Requested NDC
68071-4375-05
Package NDCs from labels
68071-4375-5, 68071-4375-05
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin Polymyxin B Sulfates and Dexamethasone - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-06-15Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2023-01-30Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-02-16Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)
2021-01-29Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4375-5Neomycin Polymyxin B Sulfates and Dexamethasone5 mL in 1 BOXSUSPENSION/ DROPS57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4375NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20240608_691bc5ca-5d61-60c2-e053-2991aa0abb93.zip

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 70 of 135 · 2,683 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FoamFresh Alco-Free Hand SanitizerBENZALKONIUM CHLORIDEWoodbine Products Company59614a1a-6b76-45e7-8b57-af307a1673cf2025-06-17WarningsExact identifier
unii: F5UM2KM3W7
ProCure Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETwin Med LLC37a3916f-cc1a-41a0-e063-6394a90a35ed2025-06-16WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
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
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDE, PRAMOXINE HCLKenvue Brands LLCd55e6b09-0587-61a9-e053-2995a90afaf52025-06-05WarningsExact identifier
unii: F5UM2KM3W7
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN BJ&A Digital Inc.9b8f2046-5886-440d-a7fc-a71138d7f34b2025-06-02WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
POLYMYXIN BPOLYMYXIN B SULFATEFOSUN PHARMA USA INCfd664927-db58-a1af-e053-6294a90a90482025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
unii: F5UM2KM3W7
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.d397ed9c-10f0-4a99-baca-a31e5e18572a2025-05-27WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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