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 11 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.edae1ea7-7a6a-4971-8a21-c2b508e96f4e2022-12-21WarningsExact identifier
unii: 77TI35393C
WELMATE Anti Diarrheal Loperamide HCl SoftgelsLOPERAMIDE HYDROCHLORIDEYYBA CORPae2e15e9-1707-296d-e053-2995a90a1b952022-11-01WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Pharmaceuticals Inc.72a7ae47-cdf3-4949-b9f8-f29b153f787f2022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
unii: 77TI35393C
Loperamide HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCd1fd9a92-9d96-4921-b789-c1f710ee23512022-06-03WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid Corporation9cee17ca-bd11-3d40-e053-2995a90ac8fe2022-05-24WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLC1537febf-2816-438b-979a-8c8f16f06de52022-05-24WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEB3ea49be2-1744-4d14-bc43-09d35fd4b3c72022-05-19WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d69532c-c71a-4880-9f74-4b37d912cabd2022-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEProficient Rx LP82e65393-25b7-4114-9c71-5840ee8bad842022-05-02WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLC93ebbb23-a9f0-4519-9793-c9056be39f232022-03-22WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGEN1a8f6a42-e74f-4725-b12e-b85c2d0151912022-03-16WarningsExact identifier
unii: 77TI35393C
Anti DiarrhealLOPERAMIDE HCLWinCo Foods3ec4c6c7-c297-4ae4-b275-4c015e922bec2022-01-06WarningsExact identifier
unii: 77TI35393C
leader anti diarrhealLOPERAMIDE HCLCardinal Health 110, LLC. dba Leader6761d752-f529-41a7-9b33-73c79481d4812021-10-07WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride, SimethiconeLOPERAMIDE HYDROCHLORIDE, SIMETHICONEGuardian Drug Company1b79204e-8a99-455b-84d6-f381fd7d11352021-06-01WarningsExact identifier
unii: 77TI35393C
basic care loperamide hydrochlorideLOPERAMIDE HCLAmazon.com Services LLC732edad8-9a3f-4ce0-a323-c8bffa4acb5f2021-02-17WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealMARC GLASSMANMarc Glassman, Inc.ff8719b7-4283-4e2c-baf6-65f250f489382020-09-01WarningsExact identifier
unii: 77TI35393C
WELMATE Anti Diarrheal Loperamide HClLOPERAMIDE HYDROCHLORIDEYYBA CORPae2e006c-0347-6c35-e053-2a95a90ab7b12020-08-31WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HCLL. Perrigo Companye5c96703-1487-4943-9b16-fa6a05e6b02e2019-12-17WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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