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 8 of 20 · 393 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
anti diarrhealLOPERAMIDE HYDROCHLORIDEPublix Super Markets Inc44773392-eac8-48b3-ae46-b27f5fe55d8d2025-12-28WarningsExact identifier
unii: 77TI35393C
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.d92819f1-d02d-4959-a019-17d44df6ed2f2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
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
rxcui: 978006
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
rxcui: 978006
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC45a1e6b0-1e2b-958a-e063-6394a90a261d2025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
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
application number: ANDA218122
rxcui: 978006
unii: 77TI35393C
Private Label DistributorLOPERAMIDE HCL 2 MGUnifirst First Aid Corporation069e7979-a223-4819-b6cf-ea2731bf156b2025-12-01WarningsExact identifier
unii: 77TI35393C
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
Loperamide Hydrochloride 2mgLOPERAMIDE HYDROCHLORIDE TABLETS USP, 2MGMARKSANS PHARMA LIMITED644fb37a-1d97-4333-a5c7-5a485ab338f72025-11-19WarningsExact identifier
unii: 77TI35393C
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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