FDA.reportPublic FDA data

NDC 67296-2172-01 - 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
67296-2172
Requested NDC
67296-2172-01
Package NDCs from labels
67296-2172-1, 67296-2172-01
Manufacturer
Redpharm Drug
Effective date
2025-12-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LOPERAMIDE HYDROCHLORIDE - Redpharm DrugRedpharm Drug2025-12-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-2172-1LOPERAMIDE HYDROCHLORIDE15 in 1 BOTTLECAPSULE153

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 10 of 20 · 393 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Direct Anti-DiarrhealFIRST AID DIRECT ANTI-DIARRHEALCintas Corp942b5af1-835e-41dd-bf65-e5b68352aa462025-09-29WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC76a976d5-8bee-4158-a94d-7fbfc5544fd42025-09-23WarningsExact identifier
unii: 77TI35393C
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC01da76d0-1979-4c45-9d39-c72ae4e4ffe22025-09-23WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3f031dfb-be55-5a44-e063-6394a90aeec52025-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Dry eye reliefPOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADERf8da3af5-9172-4023-be82-0fd5bd8916162025-09-12WarningsExact identifier
unii: 6DC9Q167V3
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEMajor Pharmaceuticals1be585e2-ef49-4210-8a2d-22a326e4cc1b2025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA218122
rxcui: 978006
unii: 77TI35393C
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 1K09F3G675
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 1K09F3G675
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
unii: 1K09F3G675
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEA-S Medication Solutions97c37571-9116-40d6-ba07-f4a5a8d9b6892025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Anti-Diarrheal/Anti-Gas CapletsLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGYYBA CORP46f5c653-eec2-4729-8aaa-79f2e188eac32025-07-24WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMylan Institutional Inc.ad71d4ab-d293-47a2-8f3f-2c9f42d76e402025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
CareOne Diarrhea ControlLOPERAMIDE HYDROCHLORIDEAmerican Sales Company95ba9c92-77f5-4344-a4f3-78eda9ebc8232025-07-21WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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