FDA.reportPublic FDA data

NDC 69837-010-01 - Home PapKit

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
69837-010
Requested NDC
69837-010-01
Package NDCs from labels
69837-010-01, 69837-010-02
Manufacturer
International Brand Management, LLC
Effective date
2016-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Home PapKit - International Brand Management, LLCInternational Brand Management, LLC2016-09-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-010-022020-01-31C16284748780-19d75b9d0-cfdc-f424-e053-dadaa90a57cecaa9637a-73a7-4627-8bb6-74bc2b2f9291

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-010-01Home PapKit28 g in 1 TUBECREAM281
69837-010-02Home PapKit1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-010HOME PAPKIT (HYDROCORTISONE) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC, 2 package rows20160915_caa9637a-73a7-4627-8bb6-74bc2b2f9291.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 50 of 51 · 1,014 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic SuspensionNEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTICA-S Medication Solutionsc895676f-446a-4a93-a3d2-addcce96b1082023-01-23Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.459a9907-1261-4a75-8388-f0e2f466939c2022-10-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
BHI SkinBERBERIS VULGARIS ROOT BARK, GRAPHITE, HYDROFLUORIC ACID, LYCOPODIUM CLAVATUM SPORE, PETROLATUM, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, AND SULFURMediNatura Inc70ab2931-bd2d-43de-bb36-d019f78e3d732022-07-07WarningsExact identifier
unii: 4T6H12BN9U
HydrocortisoneHYDROCORTISONEProficient Rx LPd50240db-f630-4008-a272-55ba5c9913042022-07-01Adverse reactionsExact identifier
rxcui: 310891
unii: WI4X0X7BPJ
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
unii: 4T6H12BN9U
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP98042cef-2839-49d6-a7bd-a1d29c74430b2022-05-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LP601cab21-c211-4c34-be7b-f4fdd97a921a2022-05-02Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc96a7b0a5-030a-42dc-80cd-35c4e9aa1b6d2021-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONESandoz Inc.99d9030f-9118-412c-a377-d1df1c8fa7232021-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.b8437441-a4a6-4fb5-82eb-e49af69704f42021-04-10Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
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: WI4X0X7BPJ
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: 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
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact identifier
unii: 4T6H12BN9U
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
unii: WI4X0X7BPJ
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
unii: 4T6H12BN9U
Discount Drug Mart Anti-itchHYDROCORTISONEDISCOUNT DRUG MART, INC.853eee29-6f57-59d4-e053-2991aa0aa6112019-03-29WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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