FDA.reportPublic FDA data

NDC 50458-400-10 - 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
Requested NDC
50458-400-10
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 1 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsExact identifier
rxcui: 978006
Loperamide HClLOPERAMIDE HCLDirect_Rx59e1c4cf-17cc-13c9-e063-6294a90af61c2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEREMEDYREPACK INC.3fdfc0e5-56a2-48a0-8ee6-390a194a29f32026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCbe99224e-dd49-4628-a5bf-ed8469ffd4a42026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLC74b9893a-18c3-4117-85c2-edab8e7b3b3b2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECoupler LLC518bb0f0-88f2-1c95-e063-6294a90a722f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepacka2594967-e737-4a23-a710-290ca0e6a2722026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC04a35525-ae8e-b41e-e063-6294a90ab10e2026-04-20WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESafecor Health LLC8b0ac05b-90c1-476b-b001-5801dd21701d2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacy, Inc.60bc8f05-f35e-45e0-ba3b-c82a87d60f5b2026-02-27WarningsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEGolden State Medical Supply, Inc.396f7e13-b357-52be-e063-6394a90a92fc2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAdvagen Pharma Ltd.,03c907d5-87f8-47a6-9544-5a24f52727392026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
rxcui: 978006
rxcui: 978009
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.d92819f1-d02d-4959-a019-17d44df6ed2f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
rxcui: 978006
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET Corporationee8a6bdf-847e-4b88-8aea-6d3daa6699942025-12-12WarningsExact identifier
rxcui: 978006

Reported adverse events (FAERS/openFDA)#

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