NDC 43386-070 - GaviLyte-H and Bisacodyl

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
43386-070
Package NDCs from labels
43386-070-17
Manufacturer
Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.
Effective date
2025-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bisacodyl - Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.Lupin Pharmaceuticals, Inc. | Novel Laboratories, Inc.2025-01-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-070-17GaviLyte-H and Bisacodyl2 L in 1 BOTTLEPOWDER, FOR SOLUTION2 L5.6 g in 2L3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-070GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.]3Unmatched20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6IGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QOGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
BISACODYLACTIVE MOIETY10X0709Y6IGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM CATIONACTIVE MOIETY295O53K152GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CHERRYINACTIVE INGREDIENTBUC5I9595WGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
LEMONINACTIVE INGREDIENT24RS0A988OGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]1

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 13 of 205 · 4,081 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare BisacodylBISACODYLStratus Pharmaceuticals795f5fb2-c13c-4dcc-a8b5-4d86a8ec1b2d2026-06-09WarningsExact identifier
unii: 10X0709Y6I
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
unii: 660YQ98I10
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d39613-20bc-5877-e063-6394a90a0ee92026-06-09WarningsExact identifier
unii: 660YQ98I10
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d48847-c0bf-1334-e063-6294a90acf7e2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53d52b7e-1e84-d4d3-e063-6294a90a9efc2026-06-09WarningsExact identifier
unii: 451W47IQ8X
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Gentle LaxativeBISACODYLCardinal Health 110, LLC. DBA Leadera82d21a9-1c40-447d-a880-4804e889459a2026-06-09WarningsExact identifier
rxcui: 308753
unii: 10X0709Y6I
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Kali MurKALI MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53ba82f3-be9f-51d7-e063-6394a90a877d2026-06-08WarningsExact identifier
unii: 660YQ98I10
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
unii: 15FIX9V2JP
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
unii: 15FIX9V2JP
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
unii: G2M7P15E5P
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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