FDA.reportPublic FDA data

NDC 68071-4229-01 - Neomycin and Polymyxin B Sulfates and Hydrocortisone

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
68071-4229
Requested NDC
68071-4229-01
Package NDCs from labels
68071-4229-1, 68071-4229-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-11-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CETYL ALCOHOL - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-11-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4229-1Neomycin and Polymyxin B Sulfates and Hydrocortisone10 mL in 1 BOXSUSPENSION/ DROPS107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4229NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE) SUSPENSION/ DROPS [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 1 package rows20241127_6296e2ed-336b-b9af-e053-2991aa0aae0c.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 33 of 58 · 1,160 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
HYDROCORTISONEHYDROCORTISONEDIRECT RXc28c3ceb-1807-b43b-e053-2995a90a2aba2025-01-17Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Equate Hydrocortisone TopicalHYDROCORTISONEWalMart1f64555d-f77e-4a83-b222-fdb3ed7d88532025-01-16WarningsExact identifier
unii: WI4X0X7BPJ
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Equate HydrocortisoneHYDROCORTISONEWalMartf5c32b4a-1159-4b7a-b8ac-256d53020dc22025-01-16WarningsExact identifier
unii: WI4X0X7BPJ
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact identifier
unii: 19371312D4
Antibiotic ApplicationBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECMC Group, Inc.da436c35-a98f-4df7-9d23-885564734cef2025-01-13WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
D-28CLAVICEPS PURPUREA SCLEROTIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, SAFFRON, FERROSOFERRIC PHOSPHATE, SULFURIC ACID, AND HORSE CHESTNUTDNA Labs, Inc.2e75490a-b63d-419b-8e33-72e30faea4502025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-10SEPIA OFFICINALIS WHOLE, SANGUINARIA CANADENSIS ROOT, SULFURIC ACID, BLACK COHOSH, AND LACHESIS MUTA VENOMDNA Labs, Inc.1e5ba502-eef4-4df0-8330-b70d1872b4bb2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-73SULFURIC ACID, SILVER, ARNICA MONTANA, BRYONIA ALBA ROOT, CAUSTICUM, AND RHODODENDRON TOMENTOSUM LEAFY TWIGDNA Labs, Inc.46fe6da9-404b-4f73-8fe8-c48c5e028ffe2025-01-13WarningsExact identifier
unii: O40UQP6WCF
D-115CAUSTICUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, IODINE, ARSENIC TRIOXIDE, BARIUM CARBONATE, ECHINACEA ANGUSTIFOLIA, ALUMINUM, ANTIMONY TRISULFIDE, STRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, SULFURIC ACID, CALCIUM SULFIDE, AND SILVER NITRATEDNA Labs, Inc.247a9133-fe4b-42a0-b3f3-7cb62eaec8c42025-01-13WarningsExact identifier
unii: O40UQP6WCF
HYDROCORTISONEHYDROCORTISONEAvPAKf3956208-291c-7374-e053-2a95a90a46282025-01-09Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ANTI-ITCH FEMININE CAREHYDROCORTISONE 0.5%OL PHARMA TECH, LLC Drs PHARMACYd6fa5ff3-ebdc-222d-e053-2a95a90a88d52025-01-09WarningsExact identifier
unii: WI4X0X7BPJ
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Drs. Pharmacy Triple Antibiotic PlusBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACYd037bfb8-0d8c-4eda-e053-2995a90ae1f22025-01-09WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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