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 32 of 58 · 1,160 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM191KREOSOTUM, NITRIC ACID, SULPHUR, SULPHURIC ACID, URTICA URENBestmade Natural Products2ea7c2e5-73d6-6820-e063-6294a90aaf1c2025-02-21WarningsExact identifier
unii: O40UQP6WCF
Cortizone 10 Ultra Soothing Itch ReliefHYDROCORTISONEChattem, Inc.8a9e2d32-a65f-4253-8041-4146f4e3b7382025-02-21WarningsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc.cf1a6da8-ba79-4bff-a13b-6effb67f6c1c2025-02-20Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: O40UQP6WCF
CORTEFHYDROCORTISONEPharmacia & Upjohn Company LLC9ce19944-dd88-4a7b-84ca-b07f4ec23bad2025-02-17Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Swimmers FriendANTIMONIUM TART., ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, CUPRUM METALLICUM, DIGITALIS PURPUREA, DROSERA, LACHESIS MUTUS, LACTICUM ACIDUM, LEDUM PALUSTRE, MAGNESIA CARBONICA, MANGANUM ACETICUM, NUX VOMICA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHURICUM ACIDUM, VERBASCUM THAPSUS, VIPERA BERUSNewton Laboratories, Inc.9d260197-0c81-0df2-e053-2a95a90a44102025-02-10WarningsExact identifier
unii: O40UQP6WCF
Bestmade Natural Products BM115BORAX, CAPSICUM, CONDURANGO, HYDRASTIS MUR, KALI PERMANGANATUM, MERC SOL, NITRIC ACID, SULPHURIC ACIDBestmade Natural Products2d901bf9-b71d-06b5-e063-6294a90a5e4a2025-02-07WarningsExact identifier
unii: O40UQP6WCF
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATENuCare Pharmaceuticals,Inc.55e1f68a-836b-5c23-e054-00144ff88e882025-02-06Warnings, Adverse reactionsExact identifier
unii: 19371312D4
signature care HydrocortisoneHYDROCORTISONESafeway9fe16fc5-77e3-47f5-a943-85bc6565c0d42025-02-06WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Incded2eb00-88ce-42b7-858e-4645c6f132392025-02-05Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact identifier
unii: WI4X0X7BPJ
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
unii: WI4X0X7BPJ
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack0cb39a3d-4d3b-4820-b3bd-eff642e08a412025-01-28Adverse reactionsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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