FDA.reportPublic FDA data

NDC 62011-0390-01 - Anti-Diarrheal

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
62011-0390
Requested NDC
62011-0390-01
Package NDCs from labels
62011-0390-1, 62011-0390-01
Manufacturer
Strategic Sourcing Services LLC | Bionpharma Inc. | Patheon Softgels Inc.
Effective date
2022-05-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsStrategic Sourcing Services LLC | Bionpharma Inc. | Patheon Softgels Inc.2022-05-24HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0390-1Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED23
62011-0390-1Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0390ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20220525_1537febf-2816-438b-979a-8c8f16f06de5.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 26 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
loperamide hydrochlorideLOPERAMIDE HCLRite Aid Corporation56334ed4-8cb0-4f5c-9051-6836f0e213372024-06-28WarningsExact identifier
unii: 77TI35393C
ABREVA Rapid Pain ReliefGLYCERIN, LIDOCAINEHaleon US Holdings LLC65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d2024-06-20WarningsExact identifier
unii: PDC6A3C0OX
anti diarrhealLOPERAMIDE HYDROCHLORIDEMeijer Distribution Inc06a0530b-b06a-466b-b366-82a2a9f7c05c2024-06-19WarningsExact identifier
unii: 77TI35393C
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.ad42a7e3-84ea-390d-e053-2a95a90a3a322024-06-14WarningsExact identifier
unii: 059QF0KO0R
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
unii: PDC6A3C0OX
Eyes Alive Eye WashWATERRIVIERA PHARMA INC081079f4-1c06-4054-b771-00fedaa666f62024-06-05WarningsExact identifier
unii: 059QF0KO0R
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDECARDINAL HEALTHbd58d6e9-628c-4c6b-b44c-da95e0417ba72024-05-31WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
Sterile WaterWATERBecton Dickinson and Company6e43c5a3-dad2-49ed-b500-964cb4563cc92024-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAmazon.com Services LLC10edd7bc-fc35-abe3-e063-6394a90aeb3f2024-05-15WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.df4e7076-fd25-aeb8-e053-2995a90a2aa02024-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
unii: PDC6A3C0OX
PEMF OptimizerAQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUMDeseret Biologicals, Inc.97d57469-4c5b-4d3f-9398-3a1a6617a6492024-04-23WarningsExact identifier
unii: 059QF0KO0R
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESDA Laboratories, Inc.d954ff63-f096-45e8-a0b6-f22e323b113f2024-04-18WarningsExact identifier
unii: 77TI35393C
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PREPARATION H Maximum StrengthGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLHaleon US Holdings LLC7cc03d2e-e708-589a-d9bb-58ebbda989c02024-04-05WarningsExact identifier
unii: PDC6A3C0OX
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepack691c5dd6-b85d-482b-a8c1-8c4b48b48dc92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAmerisource Bergen6c15f077-9f90-4262-9c17-a1ac70e45f572024-03-29WarningsExact identifier
unii: 77TI35393C
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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