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 51 of 205 · 4,081 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
throat and voiceCERATOSTIGMA WILLMOTTIANUM, FLOS, FERRUM PHOS, HOTTONIA PALUSTRIS, FLOS, KALI MUR, KALI PHOS, MAG PHOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT SULPH, SILICEASiddha Flower Essences LLC375ef37c-d5de-4762-a569-7304d98825202025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
unii: 660YQ98I10
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
grief and lossCALC PHOS, CALC SULPH, CASTANEA SATIVA FLOS, IGNATIA AMARA, JUGLANS REGIA FLOS, KALI PHOS, NAT MUR, NAT SULPH, ORNITHOLAGUM UMBELLATUM FLOS, PHOS ACIDSiddha Flower Essences LLC1bb78196-303e-4c19-8bd9-d2add41ec52b2025-12-31WarningsExact identifier
unii: 451W47IQ8X
sightAESCULUS HIPPOCASTANUM, BUD, BROMUS RAMOSUS, FLOS, CALC FLUORICA, CALC PHOS, CALC SULPH, CLEMATIS VITALBA, FLOS, FERRUM PHOS, MAG PHOS, NAT MUR, SILICEASiddha Flower Essences LLCe6a5a50f-873e-4aa0-ad66-ccfa70c75cde2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
mind and memoryAESCULUS HIPPOCASTANUM FLOS, CALC PHOS, CALC SULPH, CLEMATIS VITALBA FLOS, KALI PHOS, MAG PHOS, NAT MUR, SCLERANTHUS ANNUUS FLOW, SILICEASiddha Flower Essences LLC0d35b9a2-2123-4c14-b0b8-f45f3820ee032025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
hearingAESCULUS HIPPOCASTANUM, FLOS, CALC SULP, CALLUNA VULGARIS, FLOS, CLEMATIS VITALBA, FLOS, FER PHOS, KALI MUR, KALI SULPHSiddha Flower Essences LLCa239fd77-2687-45ad-a7c7-e9ffa15a635a2025-12-31WarningsExact identifier
unii: 660YQ98I10
energy and motivationCALC SULPH, GENTIANA AMARELLA FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPEA FLOS, PHOS ACID, ULEX EUROPAEUS FLOSSiddha Flower Essences LLCaa69dd35-9866-40d7-9820-b01fc15be58a2025-12-31WarningsExact identifier
unii: 451W47IQ8X
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 660YQ98I10
youthful skinAESCULUS HIPPOCASTANUM, BUD, AGRIMONIA EUPATORIA, FLOS, CALC FLUORICA, CALC SULPH, FERRUM PHOS, KALI SULPH, MALUS PUMILA, FLOS, NAT MUR, SILICEASiddha Flower Essences LLC6f72f1b9-d627-4110-9546-13320e62c4652025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 451W47IQ8X
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
unii: 15FIX9V2JP
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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