FDA.reportPublic FDA data

NDC 13985-009-15 - EnteDerm

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
13985-009
Requested NDC
13985-009-15
Package NDCs from labels
13985-009-75, 13985-009-15, 13985-009-30, 13985-009-40
Manufacturer
MWI | Med-Pharmex, Inc.
Effective date
1998-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nystatin, Neomycin Sulfate, Thiostrepton and Triamcinolone Acetonide OintmentMWI | Med-Pharmex, Inc.1998-10-01PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Neomycin SulfateACTIVE INGREDIENT057Y626693ENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
NystatinACTIVE INGREDIENTBDF1O1C72EENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
ThiostreptonACTIVE INGREDIENTHR4S203Y18ENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
Triamcinolone acetonideACTIVE INGREDIENTF446C597KAENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
NeomycinACTIVE MOIETYI16QD7X297ENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
NystatinACTIVE MOIETYBDF1O1C72EENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
ThiostreptonACTIVE MOIETYHR4S203Y18ENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2
Triamcinolone acetonideACTIVE MOIETYF446C597KAENTEDERM (NYSTATIN, NEOMYCIN SULFATE, THIOSTREPTON AND TRIAMCINOLONE ACETONIDE) OINTMENT [MWI]2

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 12 of 34 · 663 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONEBausch & Lomb Incoporated986e5b75-39fc-480f-9026-191b2d15dea12025-10-13Warnings, Adverse reactionsExact identifier
unii: 057Y626693
AntibioticNEOMYCIN SULFATETotal Resources International0725364b-b243-4891-af2f-a6049366d0382025-10-10WarningsExact identifier
unii: 057Y626693
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsExact identifier
unii: 057Y626693
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEMedline Industries, LP301ebb9a-033b-4f04-99ff-571e921924ca2025-10-09WarningsExact identifier
unii: 057Y626693
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEA-S Medication Solutionsf65c5847-365e-44b0-a756-1b16788684db2025-10-09Adverse reactionsExact identifier
unii: F446C597KA
XipereTRIAMCINOLONE ACETONIDEBausch & Lomb Incorporatedea6ad429-967f-4f75-a33d-e06f849bee802025-10-08Warnings, Adverse reactionsExact identifier
unii: F446C597KA
NystatinNYSTATINBryant Ranch Prepackb6aa24e6-1acb-4fd3-9ec7-11b1a69c15982025-10-08Adverse reactionsExact identifier
unii: BDF1O1C72E
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEAmneal Pharmaceuticals NY LLCbea0457d-40a7-4af9-ac77-b042356801762025-10-06Warnings, Adverse reactionsExact identifier
unii: 057Y626693
Neomycin SulfateNEOMYCIN SULFATESolaris Pharma Corporationf430c5d9-ae82-3314-e053-2a95a90af04c2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 057Y626693
TheraCare Triple Antibiotic Pain ReliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINEVeridian Healthcarefaf73908-324f-27f5-e053-6394a90aa06e2025-10-02WarningsExact identifier
unii: 057Y626693
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc2548307e-8d36-4a63-862b-f2af7856104e2025-10-01Adverse reactionsExact identifier
unii: F446C597KA
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPreferred Pharmaceuticals Inc.ac5b585c-050d-44a2-80d2-642597dc88922025-10-01WarningsExact identifier
unii: 057Y626693
NystatinNYSTATINNorthstar Rx LLC9e6d0b0d-a68f-46aa-a707-3110ecb931b42025-09-30Adverse reactionsExact identifier
unii: BDF1O1C72E
Xpect Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECintas Corporation39355db3-24d7-485f-9ce0-f0e466e965932025-09-26WarningsExact identifier
unii: 057Y626693
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%Encube Ethicals, Inc.a20baaac-002d-40ac-9c7b-f92e8ee987ea2025-09-25Adverse reactionsExact identifier
unii: F446C597KA
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCLEncube Ethicals, Inc.dfea6b2e-cd76-439d-a3da-64e2d87171632025-09-25WarningsExact identifier
unii: 057Y626693
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEEncube Ethicals, Inc.2e985ad0-aa50-4c6b-b0af-1d61489a9fda2025-09-25WarningsExact identifier
unii: 057Y626693
NystatinNYSTATINBryant Ranch Prepack840eebe8-5de2-40c5-acfd-03a98b2e790e2025-09-23Adverse reactionsExact identifier
unii: BDF1O1C72E
NystatinNYSTATINAvKARE8fd35f97-5405-2160-ca0f-35034ecd5a922025-09-18Adverse reactionsExact identifier
unii: BDF1O1C72E
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESun Pharmaceutical Industries, Inc.b353c8b1-9088-4969-8199-37876f2461cc2025-09-15Adverse reactionsExact identifier
unii: F446C597KA

Reported adverse events (FAERS/openFDA)#

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