FDA.reportPublic FDA data

NDC 48433-063-01 - 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
48433-063
Requested NDC
48433-063-01
Package NDCs from labels
48433-063-01, 48433-063-20
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Loperamide Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-07-09HUMAN PRESCRIPTION DRUG LABEL
Loperamide Hydrochloride - Safecor Health LLCSafecor Health LLC2026-03-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-063-01Loperamide Hydrochloride1 in 1 BLISTER PACKCAPSULE13
48433-063-20Loperamide Hydrochloride100 in 1 CARTONCAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-063-20EA - Each48433-0634b519fea-c4ba-4eeb-8e59-d0c91851460f12026-05-22

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 138 of 146 · 2,917 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hendel Periodontal and Tooth Pain ReliefSODIUM BORATE, TRIBASIC CALCIUM PHOSPHATE, MERCURIUS SOLUBILIS, AND SILICON DIOXIDEMediNatura Incf34e9f77-69fd-4c7f-9eea-2d721a4d27fb2022-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEDOLGENCORP, LLCd1fd9a92-9d96-4921-b789-c1f710ee23512022-06-03WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDERite Aid Corporation9cee17ca-bd11-3d40-e053-2995a90ac8fe2022-05-24WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEStrategic Sourcing Services LLC1537febf-2816-438b-979a-8c8f16f06de52022-05-24WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEHEB3ea49be2-1744-4d14-bc43-09d35fd4b3c72022-05-19WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 15FIX9V2JP
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4d69532c-c71a-4880-9f74-4b37d912cabd2022-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 978006
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEProficient Rx LP82e65393-25b7-4114-9c71-5840ee8bad842022-05-02WarningsExact identifier
unii: 77TI35393C
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe Mexico, S.A. de C.V.3e2e5f52-db54-4635-83a8-a67a683c093c2022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEAurohealth LLC93ebbb23-a9f0-4519-9793-c9056be39f232022-03-22WarningsExact identifier
unii: 77TI35393C
ALPHA SHSANGUINARIA CANADENSIS ROOT, GOLDENSEAL, SILICON DIOXIDE, POTASSIUM CHLORIDE, PULSATILLA VULGARISSchwabe North America, Inc.94de9ce3-6ee9-4322-bda2-0b4391f09d872022-03-22WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da807eb3-34a3-61b9-e053-2995a90a0e212022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da80a5ea-f603-719e-e053-2995a90a97102022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da81b21a-090a-dabf-e053-2995a90aa05e2022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareINFLUENZINUM, TELLURIUM METALLICUM, APIS MEL., ARSENICUM ALB., BELLADONNA, BRYONIA, CAPSICUM, CAUSTICUM, CINCHONA, CONIUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPH. CALC.,KALI SULPH., LYCOPODIUM, MERC. VIV., MEZEREUM, PHOSPHORUS, PLANTAGO, PULSATILLA, SILICEA, VERBASCUM, ECHINACEA, HYDRASTISNewton Laboratories, Inc.da821d05-b2f0-3582-e053-2a95a90afe592022-03-18WarningsExact identifier
unii: ETJ7Z6XBU4
Ear CareECHINACEA, HYDRASTIS CANADENSIS, APIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, BRYONIA, CAPSICUM ANNUUM, CAUSTICUM, CINCHONA OFFICINALIS, CONIUM MACULATUM, DULCAMARA, FERRUM PHOSPHORICUM, HEPAR SULPHURIS CALCAREUM, KALI SULPHURICUM, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, MEZEREUM, PHOSPHORUS, PLANTAGO MAJOR, PULSATILLA, SILICEA, VERBASCUM THAPSUS, TELLURIUM METALLICUM, INFLUENZINUMNewton Laboratories, Inc.da717cf0-54af-c4e2-e053-2995a90ac97c2022-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEAMERISOURCE BERGEN1a8f6a42-e74f-4725-b12e-b85c2d0151912022-03-16WarningsExact identifier
rxcui: 978006
unii: 77TI35393C
ACNE HPCARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINCNatural Creations, Inc.b2368ab6-e233-4473-99fa-86e1fbc2a8792022-02-14WarningsExact identifier
unii: ETJ7Z6XBU4
Anti DiarrhealLOPERAMIDE HCLWinCo Foods3ec4c6c7-c297-4ae4-b275-4c015e922bec2022-01-06WarningsExact identifier
unii: 77TI35393C
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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