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 169 of 199 · 3,964 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 3W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	15fe0429-720c-4975-953d-285aa7ee12ce	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 4W	OCTISALATE, TITANIUM DIOXIDE	Guerlain	1a733548-75a4-41ec-8d8d-3e6e9aad52e0	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 8N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	f43c867a-161f-47b7-b3d8-7f7e6c672804	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 0C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	0d75be99-7607-4964-bb6e-3c731644ab4e	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
Potassium Chloride	POTASSIUM CHLORIDE	Lupin Pharmaceuticals, Inc.	1f33bcfe-c28a-4800-9241-685d974a5d91	2023-11-08	Warnings, Adverse reactions	Exact identifier unii: 660YQ98I10
CV TOX	COCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODE	BioActive Nutritional, Inc.	8ef2fb5c-1b24-46a1-8d21-a78ce0a34a87	2023-11-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	82d210bc-b7ca-4d74-be58-85f175a75058	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	NEWCO LLC	fa3c73a3-0dfb-4673-822a-45d946dee260	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEY	TITANIUM DIOXIDE, ZINC OXIDE	SANTO REMEDIO LLC	867a88df-9a18-447f-8301-2ec91566302e	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Men	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	bf766aab-a52d-41e8-a06a-f2e536d2219b	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
PROJECT REEF SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	6bcd470c-6994-4d28-8370-4cc9d68e1e78	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30	TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE	O'Skin Studio NY	d84cca38-b673-484e-aa25-df58d904d4d3	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Aruba Aloe Balm NV	80461b6d-b1b7-4220-894d-8bd425909474	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Image Prevention Refiner Primer SPF50	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0e490f11-666c-420c-8c12-b45cd238ce47	2023-11-06	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 01 Light	TITANIUM DIOXIDE	Farmasi US LLC	97c1da03-b79c-46a3-a9f0-7aeb94ed66da	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan	TITANIUM DIOXIDE	Farmasi US LLC	deee5784-c68b-4cd7-acbf-f64391a01bfc	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium	TITANIUM DIOXIDE	Farmasi US LLC	cef1a926-b7d4-47d6-957d-e3092e60970c	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 06 Deep	TITANIUM DIOXIDE	Farmasi US LLC	2f13a160-740f-4b09-8858-e438a9ba303e	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi BB Beauty Balm Cream SPF 15- 05 Tan	TITANIUM DIOXIDE	Farmasi US LLC	3f494921-844e-4010-ab0c-144c8dce8aca	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP
Farmasi CC Color Control Cream SPF 25	TITANIUM DIOXIDE	Farmasi US LLC	f4fcfc78-9591-4a20-b9fb-88e1dc9b221d	2023-11-05	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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