FDA.reportPublic FDA data

NDC 58670-000 - Antidiarrheal LOPERAMIDE

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
58670-000
Package NDCs from labels
58670-000-10
Manufacturer
Holliday-Scott S.A. | Vasudha Pharma Chem Limited
Effective date
2013-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Antidiarrheal LOPERAMIDE - Holliday-Scott S.A. | Vasudha Pharma Chem LimitedHolliday-Scott S.A. | Vasudha Pharma Chem Limited2013-07-31OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58670-000-10Antidiarrheal LOPERAMIDE1 in 1 CARTONSOLUTION11
58670-000-10Antidiarrheal LOPERAMIDE10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58670-000ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]12 package rows20130731_273e6635-c3e6-4739-9fd0-d227c789c367.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]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 5 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTI-DIARRHEALLOPERAMIDE HCLAdvanced Rx LLC148cb6b7-28e7-48e9-b464-f42daa90e5da2025-11-04WarningsExact identifier
unii: 77TI35393C
Good Sense antidiarrhealLOPERAMIDE HCLL. Perrigo Company9928de7e-c148-4a19-a946-d4af911c26312025-10-28WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEIMO-GEN LABS LLC41d6dba5-e411-c8d2-e063-6294a90ae8fa2025-10-23WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3310a3c2-389a-4b27-a478-67c9057898542025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.580e6cd4-3f05-4996-9dc3-c50d757ae2102025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDEProficient Rx LP9cf77219-c98d-487a-a5d3-61ceda6c65f52025-10-01WarningsExact identifier
unii: 77TI35393C
First Aid Direct Anti-DiarrhealFIRST AID DIRECT ANTI-DIARRHEALCintas Corp942b5af1-835e-41dd-bf65-e5b68352aa462025-09-29WarningsExact identifier
unii: 77TI35393C
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC76a976d5-8bee-4158-a94d-7fbfc5544fd42025-09-23WarningsExact identifier
unii: 77TI35393C
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC01da76d0-1979-4c45-9d39-c72ae4e4ffe22025-09-23WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3f031dfb-be55-5a44-e063-6394a90aeec52025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticals1be585e2-ef49-4210-8a2d-22a326e4cc1b2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEA-S Medication Solutions97c37571-9116-40d6-ba07-f4a5a8d9b6892025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti-Diarrheal/Anti-Gas CapletsLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGYYBA CORP46f5c653-eec2-4729-8aaa-79f2e188eac32025-07-24WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Institutional Inc.ad71d4ab-d293-47a2-8f3f-2c9f42d76e402025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
CareOne Diarrhea ControlLOPERAMIDE HYDROCHLORIDEAmerican Sales Company95ba9c92-77f5-4344-a4f3-78eda9ebc8232025-07-21WarningsExact identifier
unii: 77TI35393C
leader anti diarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leaderf845fad8-6b3c-4c7e-94bc-d4f99f69e4f02025-07-21WarningsExact identifier
unii: 77TI35393C
Anti-diarrhealLOPERAMIDE HCLChain Drug Consortium1b82f4ce-0cf5-46d1-9894-9f1271b295692025-07-21WarningsExact identifier
unii: 77TI35393C
Leader Anti DiarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leader9079a59b-a158-4e77-a104-547959f7ba782025-07-18WarningsExact identifier
unii: 77TI35393C
basic care loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEAmazon.com Services LLCf8a3b34a-ee08-466e-ab5f-475f1c2873ec2025-07-17WarningsExact identifier
unii: 77TI35393C
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEH E B35cff261-932e-4b2e-ab21-80969c27fa922025-06-27WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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