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 7 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFSA store INC0199a50f-f367-40e7-8af0-745a959d3fde2025-04-05WarningsExact identifier
unii: 77TI35393C
basic care loperamide hydrochlorideLOPERAMIDE HCLAmazon.com Services LLCd6b8015c-f8fe-45cb-891f-566fb319b46b2025-04-03WarningsExact identifier
unii: 77TI35393C
topcare loperamide hydrochlorideLOPERAMIDE HCLTopco Associates LLC1cd497b4-d97e-447a-9251-710d2fddbf232025-04-01WarningsExact identifier
unii: 77TI35393C
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDiscount Drug Mart, Inc2e0b3aec-f436-c0fb-e063-6394a90abb512025-02-27WarningsExact identifier
unii: 77TI35393C
Anti-Diarrheal/Anti-GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEHarris Teeter, LLC2c4f882b-89d5-42ce-e063-6294a90a5fbe2025-02-05WarningsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack86d94804-ad01-4106-8f23-033f3a6bab9e2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti DiarrhealLOPERAMIDE HCLCHAIN DRUG MARKETING ASSOCIATION INC3d2d211f-546b-48fe-b47c-d4a254f952a32025-02-03WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDERedpharm Drug Incf4c23673-056e-7608-e053-2995a90a92762025-01-23WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLCf3ea8779-252e-4038-ae41-500e15c548252025-01-22WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAvPAKf8992723-dd9a-bcf6-e053-6294a90aa65c2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti-Diarrheal/Anti-Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGWal-Mart Stores, Inc.a4d5dd69-22cf-4d00-b539-133886c09e372025-01-09WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC769e3cc0-6be9-4ab6-88e1-08803d698ef72025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALMART INC.12940c3b-dc58-31fb-e063-6294a90ae8802025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBetter Living Brands, LLCfad9a144-6d1e-be06-e053-6394a90a870c2025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONENORTHEAST PHARMAd106d8e5-cdbb-4f90-8456-e692ffe7f4e62025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEFamily Dollar Stores, LLCf86d2c23-c43a-4190-e053-6394a90a95cc2025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEWALGREEN CO.e22b6c3c-3547-b507-e053-2995a90a714f2025-01-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f2025-01-07WarningsExact identifier
unii: 77TI35393C
Equate Anti Diarrheal Anti Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWALMART INC.23af573f-8d40-6b82-e063-6394a90aabab2025-01-01WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCILil' Drug Store Products, Inc.eec84fa1-262f-6e77-e053-2995a90a325b2024-12-29WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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