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 8 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Diarrheal, Circle KLOPERAMIDE HCL TABLETLil' Drug Store Products, Inc.d3aaad65-f4cd-5eb0-e053-2995a90ade842024-12-29WarningsExact identifier
unii: 77TI35393C
Anti-Diarrheal, Caseys 4goodLOPERAMIDE HCLLil' Drug Store Products, Inc.043b0ab4-8fba-37d1-e063-6394a90a4cd42024-12-29WarningsExact identifier
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
unii: 77TI35393C
Lil Drug Store Anti-DiarrhealLOPERAMIDE HYDROCHLORIDELil' Drug Store Products, Inc.fc23b13e-3005-4f23-aec2-b02a0e48ea112024-11-27WarningsExact identifier
unii: 77TI35393C
dg health anti diarrhealLOPERAMIDE HYDROCHLORIDEDolgencorp, LLCcac9e7e9-fb3a-497e-866d-347530ba4dfd2024-11-11WarningsExact identifier
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
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
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAdvanced Rx LLC287bd6d9-aa29-4f56-9c7f-5cbacbf625372024-08-11WarningsExact identifier
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
Anti Diarrheal Anti GasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEKroger Company9c7db942-c8cb-493a-a96f-452b8dfebfc62024-07-23WarningsExact identifier
unii: 77TI35393C
signature care anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONESafeway53829e72-d22c-434d-a108-1972081a6efb2024-07-22WarningsExact identifier
unii: 77TI35393C
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEWalgreen Company0999243a-c3be-41a6-b327-962e63d8c3562024-07-22WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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