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 88 of 205 · 4,081 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
MiraLAXPOLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC1771d3bf-954d-49ea-b260-3d356e5dcfa52025-11-07WarningsExact identifier
unii: G2M7P15E5P
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.8367a2ae-dfd9-4515-838c-529920291ca02025-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack2feda15e-f325-41fe-a442-41a8cc62b8552025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEA-S Medication Solutionsd486f982-a7d3-463d-a68d-89365ddaf5bb2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions4a2173ba-556b-4ad7-be81-4da79b7394902025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsde335131-bb8a-44e5-89fa-1478edbcdc0e2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack6fc9eef0-3dfc-4344-85c7-9f11d9b99b652025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsedb6c987-e2c3-421f-8a8d-849c9e17ace82025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack1b64b0c9-31a2-4ee7-8818-66de906ebeda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea20a5eb-641e-48cd-bcfa-74c04c45dfda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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