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 31 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.6fe91ddc-06b6-3a51-2b48-f6f11361ab732023-06-25WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.356d9432-d948-4b88-b297-9161b845f86b2023-06-25WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEViona Pharmaceuticals Inc330677ff-5426-40bd-af45-e3836cb778932023-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEZydus Lifesciences Limited5d13405c-8fd7-454f-9b49-3d8b9ef672b82023-06-19Exact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepackf092b8a5-80b0-40ba-af45-2ac9edaa77042023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICESf9e03d2b-2ec0-322b-e053-6394a90a15992023-04-21WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: PDC6A3C0OX
Handy Solutions Anti-DiarrhealLOPERAMIDE HYDROCHLORIDENavajo Manufacturing Company Inc.76e32e66-4af5-47a5-83ff-cbba206975d62023-03-15WarningsExact identifier
unii: 77TI35393C
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEallphamed Pharbil Arzneimittel GmbHa8c8d1d2-a8c7-462a-b620-729a9baa93c42023-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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