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 2 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-diarrhealLOPERAMIDE HCLL.N.K. International, Inc.e34f5bbc-e43c-a69e-e94d-ebc3195182042026-06-23WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLDiscount Drug Mart91843b17-3c04-482c-a2ba-143193be15952026-06-08WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDECardinal Health 107, LLCca8de42f-8aea-4e35-ab3a-75ecea718f4f2026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti DiarrhealLOPERAMIDE HCLARMY AND AIR FORCE EXCHANGE SERVICEf93a1f1f-2233-4338-9643-1ba48bd000bc2026-06-03WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8e4004be-bf79-4631-9e38-c4e7b67263132026-06-03WarningsExact identifier
unii: 77TI35393C
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEProficient Rx LP5e1358fc-76de-486a-80dd-7f41e037d9a02026-06-01WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack1e9dfe71-28a9-4b54-a0e1-7c0d82fec0d72026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEPreferred Pharmaceuticals Inc.5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf2026-05-28WarningsExact identifier
unii: 77TI35393C
loperamide hydrochlorideLOPERAMIDE HCLPreferred Pharmaceuticals Inc.0b1f8d41-51b3-4362-8de7-46bca5caff122026-05-28WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLFamily Dollar Services Inc769e7182-fa11-4645-8fca-657253f28d9c2026-05-27WarningsExact identifier
unii: 77TI35393C
good sense anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONEL. Perrigo Company2cda08a8-3f5e-430c-84a3-d29b97d647af2026-05-20WarningsExact identifier
unii: 77TI35393C
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLH E B8f7fea50-70cf-4f9f-a655-30371e5b9d9f2026-05-19WarningsExact identifier
unii: 77TI35393C
Anti DiarrhealLOPERAMIDE HCLChain Drug Marketing Association, Inc.dd993f38-a31f-4739-9496-e14186a890532026-05-18WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLUnited Natural Foods, Inc. dba UNFIf16e07f3-0efb-4451-adbb-e427f9abc7ae2026-05-18WarningsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDECoupler LLC518bb0f0-88f2-1c95-e063-6294a90a722f2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepacka2594967-e737-4a23-a710-290ca0e6a2722026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
berkley and jensen anti diarrhealLOPERAMIDE HYDROCHLORIDEBJWCdc29a8e9-f916-49d2-b9a6-d2b4537d7b582026-05-08WarningsExact identifier
unii: 77TI35393C
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLCd388f536-704a-4d6e-ab27-c1a96e9394132026-05-05WarningsExact identifier
unii: 77TI35393C
MEDIQUE DiamodeLOPERAMIDE HYDROCHLORIDESportpharm LLCac674e5a-94df-4a35-9854-4e66cc17e5092026-04-24WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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