NDC 43386-010 - 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: 43386-010
Package NDCs from labels: 43386-010-61
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
43386-010-61	GaviLyte-H and Bisacodyl	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1	5 mg	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-010	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 188 of 197 · 3,933 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	5a22b123-9077-4b8a-ac4c-1bdd475c6ac3	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Calico	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	4647828c-661d-4ebe-b27e-13d8b89647b8	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	c82f36da-16ce-45f4-9786-2026a359060a	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Wheat	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	3d86dca5-9e33-4284-a4c1-f5eed64b0620	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Willow	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	0489a046-2173-4137-abff-c6a7cdb5e8fd	2021-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
Post - Vaccination	INFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUM	Newton Laboratories, Inc.	c67b3a39-ef78-5e81-e053-2a95a90a4786	2021-07-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Warm Beige	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	58465981-e84c-4eaf-b7d5-fad1666f63fc	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Bamboo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	b2259b27-e1a5-482c-8916-356c1ee9774a	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Deeply Bronze	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	199dde64-1dd3-4eb6-baef-261c97162f79	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Creme	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	753c34f2-3cb8-4df7-9aeb-ea926fb0279a	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Dune	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	745dd675-86ee-4acc-8333-4870e0a57c75	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
signature care clearlax	POLYETHYLENE GLYCOL 3350	Safeway	91d2e780-2aae-411c-b7b3-820302f0f63e	2021-05-13	Warnings	Exact identifier unii: G2M7P15E5P
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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