FDA.reportPublic FDA data

NDC 68071-3618-01 - LOPERAMIDE HYDROCHLORIDE

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
68071-3618
Requested NDC
68071-3618-01
Package NDCs from labels
68071-3618-1, 68071-3618-2, 68071-3618-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loperamide Hydrochloride Capsules, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-08-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3618-1LOPERAMIDE HYDROCHLORIDE12 in 1 BOTTLECAPSULE122
68071-3618-2LOPERAMIDE HYDROCHLORIDE20 in 1 BOTTLECAPSULE202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3618LOPERAMIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20240820_1adb7a28-9dc6-3f8b-e063-6394a90a9335.zip

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 1 of 21 · 404 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEYYBA CORP5a728c6d-26ec-3316-e063-6394a90ade082026-09-09WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 77TI35393C
anti diarrhealLOPERAMIDE HYDROCHLORIDECVS Pharmacyd8a55fb6-bb57-42d6-8e20-67fc91f380972026-09-04WarningsExact identifier
unii: 77TI35393C
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurohealth LLCf9a53a23-a8ea-4521-8f0b-1bc2a658ff682026-08-28WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
anti diarrheal and anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONECVS Pharmacy065699b5-217e-432f-a253-cea2d3f622332026-08-26WarningsExact identifier
unii: 77TI35393C
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
IMODIUM Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE AND DIMETHICONEKenvue Brands LLCecb91e47-2b0c-47c8-9256-4623d8bc825e2026-08-25WarningsExact identifier
unii: 77TI35393C
Loperamide HClLOPERAMIDE HCLDirect_Rx59e1c4cf-17cc-13c9-e063-6294a90af61c2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA218122
rxcui: 978006
unii: 77TI35393C
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
anti diarrhealLOPERAMIDE HCLCVS Pharmacy68467222-c8b4-4029-a180-59a57d0090d32026-08-19WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLDOLGENCORP, LLC78814c22-5be2-45ee-b0be-977844746fcc2026-08-18WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HCLRedpharm Drug594b9c93-488a-0df0-e063-6394a90a2e992026-08-18WarningsExact identifier
unii: 77TI35393C
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEStrides Pharma, Inc.4178b3cc-e1ca-4912-8b1f-eac0110a39402026-08-13WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEYYBA CORP568064c9-139d-7233-e063-6294a90a10d42026-08-10WarningsExact identifier
unii: 77TI35393C
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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