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 9 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 978010
unii: 77TI35393C
Anti-Diarrheal, Circle KLOPERAMIDE HCL TABLETLil' Drug Store Products, Inc.d3aaad65-f4cd-5eb0-e053-2995a90ade842024-12-29WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Anti-Diarrheal, Caseys 4goodLOPERAMIDE HCLLil' Drug Store Products, Inc.043b0ab4-8fba-37d1-e063-6394a90a4cd42024-12-29WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDISCOUNT DRUG MART, INC.ed28814d-9733-46ff-930f-b148e31f2f512024-12-23WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEKROGER COMPANYff5dcb48-318c-4f2a-8df2-73ff6dd2a49e2024-12-23WarningsExact identifier
unii: 77TI35393C
Anti DiarrhealLOPERAMIDE HCLH E B8ecbfd81-fe45-49b4-b835-a32192de8f532024-12-02WarningsExact identifier
application number: ANDA075232
rxcui: 978010
unii: 77TI35393C
Lil Drug Store Anti-DiarrhealLOPERAMIDE HYDROCHLORIDELil' Drug Store Products, Inc.fc23b13e-3005-4f23-aec2-b02a0e48ea112024-11-27WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
dg health anti diarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, LLCcac9e7e9-fb3a-497e-866d-347530ba4dfd2024-11-11WarningsExact identifier
application number: ANDA075232
rxcui: 978010
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEA-S Medication Solutionsd572ecf7-ddc3-46fb-80a6-80b7b1b90a1b2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDESafeway9d0c565f-64a2-4300-b1e2-5dee9546ea142024-10-22WarningsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDENorthStar Rx LLC858c2b62-98e6-46d7-9253-9b3a00040a4e2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDEPUBLIX SUPER MARKETS INC17035ff7-8ba8-131c-e063-6394a90af5ea2024-10-03WarningsExact identifier
unii: 77TI35393C
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack865cf4c7-f643-451b-b0d4-d30bda621f7d2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1adb7a28-9dc6-3f8b-e063-6394a90a93352024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals, Inc.3e898141-8d40-49f1-e054-00144ff88e882024-08-13Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
injoy diarrhea reliefLOPERAMIDE HCLL. Perrigo Companycf5ccdf8-ab27-429f-a1b4-c51ced0210462024-08-12WarningsExact identifier
application number: ANDA075232
rxcui: 978010
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAdvanced Rx LLC287bd6d9-aa29-4f56-9c7f-5cbacbf625372024-08-11WarningsExact identifier
rxcui: 978010
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsf245e8f4-e06e-492e-8c46-af1fce1633fc2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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