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 12 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEWalmart44155cf8-6fd9-d16f-e063-6394a90ac7312025-12-20WarningsExact identifier
unii: PDC6A3C0OX
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Signature Care Eye Drops Redness and Dry Eye ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEBetter Living Brands LLC901f3bbe-e1bb-4e44-879c-711e59813a7f2025-12-19WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LemonGLYCERINTwinMed LLCfc88eec0-c66c-5d6d-e053-6294a90a13d22025-12-18WarningsExact identifier
unii: PDC6A3C0OX
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
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: PDC6A3C0OX
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWALGREENS50814751-8bee-4768-bf6c-e9da3400090b2025-12-15WarningsExact identifier
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
topcare anti diarrhealLOPERAMIDE HYDROCHLORIDETopco Associates LLCda347b47-d8a5-4cf9-9579-79e6fe57fed52025-12-13WarningsExact identifier
unii: 77TI35393C
ElixirLidoFast Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEELIXIR HEALTHCARE USA, LLC.45de9dfa-6c89-1eae-e063-6294a90a4dac2025-12-13WarningsExact identifier
unii: PDC6A3C0OX
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
application number: NDA021855
rxcui: 978006
unii: 77TI35393C
Kroger HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLKroger Company45b2dd86-7fb0-07bf-e063-6394a90a18842025-12-11WarningsExact identifier
unii: PDC6A3C0OX
anti-diarrhealLOPERAMIDE HYDROCHLORIDEMEIJER DISTRIBUTION INC440fb3ce-4106-4169-b187-cfbfdd2f42c12025-12-11WarningsExact identifier
application number: NDA021855
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
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
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
rxcui: 978006
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

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