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 2 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-DiarrhealLOPERAMIDE HCLWalgreen Company31f9b652-e9c9-46ed-a46c-22d30ad110042026-07-10WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLC74b9893a-18c3-4117-85c2-edab8e7b3b3b2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEKesin Pharma Corporation52e6ecc5-5f3d-9989-e063-6294a90af2dc2026-06-30WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDESportpharm LLCeb93a17e-7daf-4a9e-94a1-442039a383bd2026-06-26WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Anti-diarrhealLOPERAMIDE HCLL.N.K. International, Inc.e34f5bbc-e43c-a69e-e94d-ebc3195182042026-06-23WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Anti-DiarrhealLOPERAMIDE HCLDiscount Drug Mart91843b17-3c04-482c-a2ba-143193be15952026-06-08WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Anti DiarrhealLOPERAMIDE HCLARMY AND AIR FORCE EXCHANGE SERVICEf93a1f1f-2233-4338-9643-1ba48bd000bc2026-06-03WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8e4004be-bf79-4631-9e38-c4e7b67263132026-06-03WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEProficient Rx LP5e1358fc-76de-486a-80dd-7f41e037d9a02026-06-01WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
loperamide hydrochlorideLOPERAMIDE HCLPreferred Pharmaceuticals Inc.0b1f8d41-51b3-4362-8de7-46bca5caff122026-05-28WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLFamily Dollar Services Inc769e7182-fa11-4645-8fca-657253f28d9c2026-05-27WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
unii: 77TI35393C
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsExact identifier
application number: ANDA075232
rxcui: 978010
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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