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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43386-070-17	GaviLyte-H and Bisacodyl	2 L in 1 BOTTLE	POWDER, FOR SOLUTION	2 L	5.6 g in 2L	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-070	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [LUPIN PHARMACEUTICALS, INC.]	3	Unmatched	20250130_78fe1c29-e22a-4615-a2f9-a61cd4eb38a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GAVILYTE-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. 27	INACTIVE INGREDIENT	2LRS185U6K	GAVILYTE-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. 2	INACTIVE INGREDIENT	L06K8R7DQK	GAVILYTE-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. 6	INACTIVE INGREDIENT	H77VEI93A8	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
LEMON	INACTIVE INGREDIENT	24RS0A988O	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
METHACRYLIC ACID	INACTIVE INGREDIENT	1CS02G8656	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
ORANGE	INACTIVE INGREDIENT	5EVU04N5QU	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GAVILYTE-H AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL DELAYED-RELEASE TABLET) KIT [GAVIS PHARMACEUTICALS, LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	GAVILYTE-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 168 of 199 · 3,964 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Welby ClearLax	POLYETHYLENE GLYCOL 3350	Aldi, Inc	d64caba5-614f-4edc-bb47-ce4fed38ce45	2023-11-10	Warnings	Exact identifier unii: G2M7P15E5P
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	fb677ad0-2791-44ec-9720-951471ec009a	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Shaklee Youth Age Defense Mineral Moisturizer SPF 30	TITANIUM DIOXIDE	Shaklee Corporation	f4888fdc-09f9-43de-8c81-5a0f5e767d4e	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Spit and Polish Sun Smart Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Naturally Uncommon, LLC	af879a05-1483-5c11-e053-2995a90af45d	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Active	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Physical Sunscreen SPF50 80 min WR 159-100	TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0cca7b65-e24a-429c-b157-5f4e343424ab	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a20dc51a-1f6c-4a6d-97f6-2f048e0689a0	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a6c8b20f-6377-443b-a89b-8b5d40c65ad8	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b6591b2e-9e55-4f25-958c-f36f1ef85749	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	6e2ae7cb-c390-4996-95e8-ae8fadefa8bd	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a143c8cb-185c-4fd8-a901-3c0d9ffb8290	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	3d6e438d-9ea4-4253-9153-748d3c974265	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	173aeaab-a286-48ed-9033-10b13f547bbd	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	d877575a-25f3-49bd-b403-ecf6a1eb483a	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	24e1e576-9edd-45aa-a883-2a2d18a1cb5e	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a8fffe38-5f90-4078-b553-30036659a2ee	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	bfa2b2be-958c-439f-b363-2623df2b8501	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15f73322-0b27-4412-b368-84bc768f55e8	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b70b8ffc-091a-4969-86a7-6c3e1b9b9d74	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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