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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti-diarrhealLOPERAMIDE HYDROCHLORIDEPUBLIX SUPER MARKETS INC17035ff7-8ba8-131c-e063-6394a90af5ea2024-10-03WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack865cf4c7-f643-451b-b0d4-d30bda621f7d2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1adb7a28-9dc6-3f8b-e063-6394a90a93352024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3e898141-8d40-49f1-e054-00144ff88e882024-08-13Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf245e8f4-e06e-492e-8c46-af1fce1633fc2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.af0b886f-c065-26dc-e053-2995a90ac4712024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHbd58d6e9-628c-4c6b-b44c-da95e0417ba72024-05-31WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df4e7076-fd25-aeb8-e053-2995a90a2aa02024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack691c5dd6-b85d-482b-a8c1-8c4b48b48dc92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc5322892-cb14-4a25-9b42-e62e491bc1012024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBionpharma Inc.6e60cb25-6af9-4f17-b740-a5e7b5bb2a092023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.a14bd404-cc79-06e0-e053-2a95a90a68412023-12-26WarningsExact identifier
rxcui: 978006
anti-diarrhealLOPERAMIDE HYDROCHLORIDEVALU MERCHANDISERS COMPANYfed347ad-cfbb-9ee8-e053-6394a90ad2752023-10-10WarningsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8d142533-4e87-4030-8fe9-4fc7473b04422023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.6fe91ddc-06b6-3a51-2b48-f6f11361ab732023-06-25WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.356d9432-d948-4b88-b297-9161b845f86b2023-06-25WarningsExact identifier
rxcui: 978006
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEViona Pharmaceuticals Inc330677ff-5426-40bd-af45-e3836cb778932023-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEZydus Lifesciences Limited5d13405c-8fd7-454f-9b49-3d8b9ef672b82023-06-19Exact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepackf092b8a5-80b0-40ba-af45-2ac9edaa77042023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICESf9e03d2b-2ec0-322b-e053-6394a90a15992023-04-21WarningsExact identifier
rxcui: 978006

Reported adverse events (FAERS/openFDA)#

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