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 4 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti DiarrhealLOPERAMIDE HCLWal-Mart Stores Incb480916e-6383-468d-9e3e-499efea925222026-01-19WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDEHyVee Inc9434cefe-6b13-47c4-b2f7-b8d566c5a4ff2026-01-13WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAdvagen Pharma Ltd.,03c907d5-87f8-47a6-9544-5a24f52727392026-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.47a779c7-c709-6208-e063-6394a90a6dfa2026-01-05WarningsExact identifier
unii: 77TI35393C
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDENorthwind Health Company, LLCdb47cc0a-e301-0310-e053-2a95a90a7f5d2026-01-01WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDEPublix Super Markets Inc44773392-eac8-48b3-ae46-b27f5fe55d8d2025-12-28WarningsExact identifier
unii: 77TI35393C
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.d92819f1-d02d-4959-a019-17d44df6ed2f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
CareOne Diarrhea ControlLOPERAMIDE HCLAmerican Sales Company17569b2c-38f9-43bd-87ac-eb82b64866e62025-12-17WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
unii: 77TI35393C
topcare anti diarrhealLOPERAMIDE HYDROCHLORIDETopco Associates LLCda347b47-d8a5-4cf9-9579-79e6fe57fed52025-12-13WarningsExact identifier
unii: 77TI35393C
Loperamide hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEBionpharma Inc.9b0a802f-6fae-4142-ad2f-4b16ed67400e2025-12-12WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETARGET Corporationee8a6bdf-847e-4b88-8aea-6d3daa6699942025-12-12WarningsExact identifier
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC45a1e6b0-1e2b-958a-e063-6394a90a261d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticalsbe8f1c7d-fd4e-48d4-80b0-1d92a2ba6a702025-12-06WarningsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDERedpharm Drug3b0ac1a9-ffa6-9af6-e063-6294a90a26782025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Private Label DistributorLOPERAMIDE HCL 2 MGUnifirst First Aid Corporation069e7979-a223-4819-b6cf-ea2731bf156b2025-12-01WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride 2mgLOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MGMARKSANS PHARMA LIMITED644fb37a-1d97-4333-a5c7-5a485ab338f72025-11-19WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAmerican Health Packaging42989f90-8ff5-44d1-a462-28c18ce027382025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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