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 2 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC45a1e6b0-1e2b-958a-e063-6394a90a261d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDERedpharm Drug3b0ac1a9-ffa6-9af6-e063-6294a90a26782025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAmerican Health Packaging42989f90-8ff5-44d1-a462-28c18ce027382025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3310a3c2-389a-4b27-a478-67c9057898542025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.580e6cd4-3f05-4996-9dc3-c50d757ae2102025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
First Aid Direct Anti-DiarrhealFIRST AID DIRECT ANTI-DIARRHEALCintas Corp942b5af1-835e-41dd-bf65-e5b68352aa462025-09-29WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3f031dfb-be55-5a44-e063-6394a90aeec52025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticals1be585e2-ef49-4210-8a2d-22a326e4cc1b2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEA-S Medication Solutions97c37571-9116-40d6-ba07-f4a5a8d9b6892025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Institutional Inc.ad71d4ab-d293-47a2-8f3f-2c9f42d76e402025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35a938af-decf-5b5d-e063-6294a90a9ab02025-05-21WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.35aa2daf-3486-7ee2-e063-6394a90ad4732025-05-21WarningsExact identifier
rxcui: 978006
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAlbertsons Companies1d4ec76d-ff0d-a55d-e063-6294a90ae22c2025-04-07WarningsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack86d94804-ad01-4106-8f23-033f3a6bab9e2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAvPAKf8992723-dd9a-bcf6-e053-6294a90aa65c2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.ed28814d-9733-46ff-930f-b148e31f2f512024-12-23WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYff5dcb48-318c-4f2a-8df2-73ff6dd2a49e2024-12-23WarningsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEA-S Medication Solutionsd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDENorthStar Rx LLC858c2b62-98e6-46d7-9253-9b3a00040a4e2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006

Reported adverse events (FAERS/openFDA)#

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