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 57 of 58 · 1,149 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.b8437441-a4a6-4fb5-82eb-e49af69704f42021-04-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
POLYMYXIN BPOLYMYXIN B SULFATEFresenius Kabi USA, LLCfbc12c18-567b-41bc-89d0-efd29616615c2021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Visceral PolarityACONITUM NAP, ARG NIT, CHININUM PUR, ECHINACEA PURP, PLUM MET, SEPIA, SULPHURICUM ACNET Remedies971e74ea-f72f-403e-bc79-02901e5019e82021-01-21WarningsExact identifier
unii: O40UQP6WCF
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN, POLYMYXIN B SULFATES, DEXAMETHASONEProficient Rx LPbd9f3220-6d42-4863-aa2a-b17b138d095d2021-01-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
Trimethoprim sulfate and Polymyxin B sulfateTRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEProficient Rx LP2c5579eb-ad81-415e-8dcb-9f1c94c897ae2021-01-01Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEProficient Rx LPd55f1783-9c49-4f90-9ff8-6f132e7b325e2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEProficient Rx LPaa7b8a3f-06dd-4190-96a5-f86195bd21972021-01-01Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
unii: O40UQP6WCF
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEAsclemed USA, Inc.7c78ec84-8b7c-42f1-a879-3bf27a1daa712020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
unii: 19371312D4
unii: WI4X0X7BPJ
XereseACYCLOVIR AND HYDROCORTISONEBausch Health US LLC3b6ac164-0f1e-4f36-94a1-1fdb07d710f52020-08-03Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEActavis Pharma, Inc.aa9dba84-eb38-4ec3-8555-87c948bf23842020-07-01Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
unii: WI4X0X7BPJ
Discount Drug Mart Anti-itchHYDROCORTISONEDISCOUNT DRUG MART, INC.853eee29-6f57-59d4-e053-2991aa0aa6112019-03-29WarningsExact identifier
unii: WI4X0X7BPJ
GastrozenCOFFEA TOSTA, GLYCYRRHIZA, PHYTOLACCA, TARAXACUM, HYDRASTIS, ARSENICUM ALB, GELSEMIUM, MERC SOLUB, NITRICUM AC, NUX VOM, PETROLEUM, PHOSPHORICUM AC, PHOSPHORUS, BROMIUM, CADMIUM SULPHURICUM, CINCHONA, CONIUM, HYDROGEN, IODIUM, LACHESIS, PULSATILLA, SILICEA, SULPHURICUM ACNatural Creations, Inc98dd756f-6774-47c3-bdfb-deff82fb801d2018-12-21WarningsExact identifier
unii: O40UQP6WCF
Injure GelARNICA MONTANA, CALENDULA OFFICINALIS, HYPERICUM PERF, SYMPHYTUM OFF, BELLIS PER, LEDUM PALUSTRE, SULPHURICUM AC, CALC FLUOR, FERRUM PHOS, RHUS TOX, NAT SULPHURICUMNatural Creations, Inc8893c906-0dab-44ef-956b-b5427d4dbf7f2018-12-21WarningsExact identifier
unii: O40UQP6WCF
Hangover ReliefASAFETIDA,CAPSICUM,POTASSIUM DICHROMATE,COLA NUT,LACHESIS MUTA VENOM,STRYCHNOS NUX-VOMICA SEED,RANUNCULUS BULBOSUS,SULFURIC ACID,ZINC.Homeocare Laboratories93b4a184-572c-48ef-9fc0-8e357a1e0d1b2018-12-18WarningsExact identifier
unii: O40UQP6WCF
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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