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 31 of 138 · 2,743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Benzalkonium chlorideBENZALKONIUM CHLORIDEPharmacy Value Alliance, LLC5f9521f2-53f2-4d7e-9116-36e94e2d06952026-02-05Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDINA-S Medication Solutions9691178e-5323-40ce-a8b3-f79e88f027972026-02-04Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
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
ANTIBACTERIALBENZALKONIUM CHLORIDETopco Associates LLC463f3a53-921a-65cb-e063-6394a90ab4f22026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Washing Antibacterial FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC0f72f0cb-9e8e-43bb-862e-0024771ece1b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Tork Hand Sanitizing Alcohol-Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCc9761e9d-21d5-4dcd-8e31-bb722c5178912026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand SanitizerBENZALKONIUM CHLORIDE 0.1%W/WGeorgia-Pacific Consumer Products LPd4575f18-d96c-465d-8580-650ee7df18f62026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue UltraBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP7ea3f69f-e150-4beb-af1e-04ffc5a3b7952026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial with Moisturizers, Fragrance FreeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb68252e4-ac4d-49e5-9f21-5f97c860e8f02026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
enMotion Antimicrobial with Moisturizers, Tranquil AloeBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LPb5a2429f-7a31-424d-8174-12dff6d87a7d2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Pacific Blue Ultra Antimicrobial Pacific CitrusBENZALKONIUM CHLORIDEGeorgia-Pacific Consumer Products LP4fc3122a-16c0-4e2c-aebb-b266857781172026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Terramed Just Think Comfort Armor Antibacterial Cleansing BarBENZALKONIUM CHLORIDERida LLC68e59a77-6a0c-42e2-a6a9-1353470d2e082026-02-04WarningsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEPermatexcfd3279e-9584-49d7-bf4b-6ef00d501d9b2026-02-04Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
RoyceDerm Antibacterial Body WashBENZALKONIUM CHLORIDE 0.13%RoyceDerm LLC4a0c66b1-5a6f-b9b9-e063-6294a90a3d772026-02-04WarningsExact identifier
unii: F5UM2KM3W7
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEA-S Medication Solutions498f34db-89e8-49cc-8543-87da3f4344ec2026-02-04Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

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