FDA.reportPublic FDA data

NDC 70000-0589-01 - leader anti diarrheal

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
70000-0589
Requested NDC
70000-0589-01
Package NDCs from labels
70000-0589-1, 70000-0589-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2021-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
leader anti diarrheal - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2021-10-07HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0589-1leader anti diarrheal24 in 1 CARTONTABLET, FILM COATED241
70000-0589-1leader anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0589LEADER ANTI DIARRHEAL (LOPERAMIDE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, Legacy NDC, 2 package rows20211008_6761d752-f529-41a7-9b33-73c79481d481.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0589-1EA - Each70000-0589a9fb3fd4-26cc-4124-8c02-a985860e338f12022-05-04

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 8 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti-diarrhealLOPERAMIDE HYDROCHLORIDEAlbertsons Companies1d4ec76d-ff0d-a55d-e063-6294a90ae22c2025-04-07WarningsExact identifier
unii: 77TI35393C
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
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
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
rxcui: 978010
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDERedpharm Drug Incf4c23673-056e-7608-e053-2995a90a92762025-01-23WarningsExact identifier
application number: ANDA075232
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLCf3ea8779-252e-4038-ae41-500e15c548252025-01-22WarningsExact identifier
rxcui: 978010
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

Reported adverse events (FAERS/openFDA)#

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