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 27 of 34 · 675 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
unii: PDC6A3C0OX
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc5322892-cb14-4a25-9b42-e62e491bc1012024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Consortium, LLCb070896b-1e22-41d4-a66d-8d3be16992172024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEZee Medical Inc07e1f89c-5bf6-4539-848a-4435e7deb0d22024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEOhm Laboratories Inc.c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c62024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDiscount Drug Mart6bc9771d-09f8-47ce-bbbd-8dd9aae976932024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEMarc Glassman, Inc.01efdce1-25ce-45ff-aeb6-f6fba00e59aa2024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEValu Merchandisers Company33335063-49a9-4e08-9d77-4cd80e94f0212024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEFred's Inc.a3bf91ae-22f3-4402-b73c-de026f2d04752024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Marketing Association Inc.237b845b-0f02-410d-9750-c95123e6142d2024-01-11WarningsExact identifier
unii: 77TI35393C
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: PDC6A3C0OX
F02 ANGR-FLXADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLEApex Energetics Inc.bc7c2bf3-8b0d-766f-e053-2a95a90ad34c2024-01-08WarningsExact identifier
unii: 059QF0KO0R
F09 LTGOADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALISApex Energetics Inc.bd1e652f-b3a4-c5bd-e053-2995a90ae03f2024-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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