FDA.reportPublic FDA data

NDC 50458-400 - Imodium

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
50458-400
Package NDCs from labels
50458-400-10
Manufacturer
McNeil Consumer Healthcare
Effective date
2008-02-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Imodium - McNeil Consumer HealthcareMcNeil Consumer Healthcare2008-02-26HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50458-400-10Imodium100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50458-400IMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]11 package rows20080305_871E2A73-A1E9-4952-8CF2-15DA430117CE.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Loperamide HydrochlorideACTIVE INGREDIENT77TI35393CIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
LoperamideACTIVE MOIETY6X9OC3H4IIIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
CornstarchINACTIVE INGREDIENTIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
FD&C Yellow No. 6INACTIVE INGREDIENTIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30IMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1
TalcINACTIVE INGREDIENT7SEV7J4R1UIMODIUM (LOPERAMIDE HYDROCHLORIDE) CAPSULE [MCNEIL CONSUMER HEALTHCARE]1

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 4 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEallphamed Pharbil Arzneimittel GmbHa8c8d1d2-a8c7-462a-b620-729a9baa93c42023-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
rxcui: 978006
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.edae1ea7-7a6a-4971-8a21-c2b508e96f4e2022-12-21WarningsExact identifier
rxcui: 978006
WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPae2e15e9-1707-296d-e053-2995a90a1b952022-11-01WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Pharmaceuticals Inc.72a7ae47-cdf3-4949-b9f8-f29b153f787f2022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCd1fd9a92-9d96-4921-b789-c1f710ee23512022-06-03WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid Corporation9cee17ca-bd11-3d40-e053-2995a90ac8fe2022-05-24WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLC1537febf-2816-438b-979a-8c8f16f06de52022-05-24WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEB3ea49be2-1744-4d14-bc43-09d35fd4b3c72022-05-19WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d69532c-c71a-4880-9f74-4b37d912cabd2022-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGEN1a8f6a42-e74f-4725-b12e-b85c2d0151912022-03-16WarningsExact identifier
rxcui: 978006
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.8f1ee652-a4f7-4e5b-874f-46aa641cd43f2019-09-09WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.8bf47ac3-746f-47c3-82b2-32ac979ff9632016-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
DE89D8FB-3653-3030-5A4B-3DDF987C751D871E2A73-A1E9-4952-8CF2-15DA430117CE2008-02-26Warnings, Adverse reactionsExact identifier
spl id: DE89D8FB-3653-3030-5A4B-3DDF987C751D
spl set id: 871E2A73-A1E9-4952-8CF2-15DA430117CE

Reported adverse events (FAERS/openFDA)#

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