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 9 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEDolgencorp, LLC09798231-39cd-49b2-9be5-ea51e52f0a6d2024-07-22WarningsExact identifier
unii: 77TI35393C
Basic Care Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEAmazon.com Services LLCaa79234e-1fbd-4279-b4b1-46b4f041b4e82024-07-22WarningsExact identifier
unii: 77TI35393C
equaline anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEUnited Natural Foods, Inc. dba UNFI2ce0b37e-6dc4-423f-a1d6-a2cb623946d52024-07-22WarningsExact identifier
unii: 77TI35393C
up and up anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONETarget Corporationef75085c-95df-4901-9c97-069fcfc3eef72024-07-22WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.af0b886f-c065-26dc-e053-2995a90ac4712024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
anti diarrheal plus anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEMeijer Distribution Ince2c9a752-618a-4e34-89a5-671aab4013ac2024-07-11WarningsExact identifier
unii: 77TI35393C
foster and thrive anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEStrategic Sourcing Services LLC9132dc1c-8e16-4236-881e-863f5e57f0ab2024-07-08WarningsExact identifier
unii: 77TI35393C
loperamide hydrochlorideLOPERAMIDE HCLRite Aid Corporation56334ed4-8cb0-4f5c-9051-6836f0e213372024-06-28WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDEMeijer Distribution Inc06a0530b-b06a-466b-b366-82a2a9f7c05c2024-06-19WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHbd58d6e9-628c-4c6b-b44c-da95e0417ba72024-05-31WarningsExact identifier
unii: 77TI35393C
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC10edd7bc-fc35-abe3-e063-6394a90aeb3f2024-05-15WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df4e7076-fd25-aeb8-e053-2995a90a2aa02024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESDA Laboratories, Inc.d954ff63-f096-45e8-a0b6-f22e323b113f2024-04-18WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack691c5dd6-b85d-482b-a8c1-8c4b48b48dc92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAmerisource Bergen6c15f077-9f90-4262-9c17-a1ac70e45f572024-03-29WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc5322892-cb14-4a25-9b42-e62e491bc1012024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Consortium, LLCb070896b-1e22-41d4-a66d-8d3be16992172024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEZee Medical Inc07e1f89c-5bf6-4539-848a-4435e7deb0d22024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEOhm Laboratories Inc.c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c62024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDiscount Drug Mart6bc9771d-09f8-47ce-bbbd-8dd9aae976932024-01-11WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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