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 93 of 205 · 4,081 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Jacksons Cell Salts KALI MUR 6X 5	KALI MURIATICUM	Zettl Health Inc.	41ed34d0-94c3-ce79-e063-6294a90a08cb	2025-10-24	Warnings	Exact identifier unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE	ICU Medical Inc.	aba60c84-94d9-46d0-bdbb-25e0c4e8cc41	2025-10-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE	THG Beauty USA LLC	397b4338-fec8-5228-e063-6394a90ad97d	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE	THG Beauty USA LLC	38c80373-1d5a-c7f4-e063-6294a90aa9c2	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35	ZINC OXIDE, TITANIUM DIOXIDE	THG Beauty USA LLC	254b4692-a459-6119-e063-6394a90a0a60	2025-10-23	Warnings	Exact identifier unii: 15FIX9V2JP
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and Teeth	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	MIRANDA CASTRO'S SHOP, LLC	267fb775-a03c-f100-e063-6394a90aa826	2025-10-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
miranda castros HEALING FOR INSECT BITES AND STINGS	CALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENS	MIRANDA CASTRO'S SHOP, LLC	1f99d32e-2394-411a-e063-6294a90ac454	2025-10-23	Warnings	Exact identifier unii: 451W47IQ8X
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic Combination	CALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEA	MIRANDA CASTRO'S SHOP, LLC	266e907b-4cdb-fb4f-e063-6394a90aa434	2025-10-23	Warnings	Exact identifier unii: ETJ7Z6XBU4
Bisacodyl	BISACODYL	GERI-CARE PHARMACEUTICAL CORP	a747a57a-028e-70ea-e053-2a95a90ac184	2025-10-23	Warnings	Exact identifier unii: 10X0709Y6I
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	2f5c975f-0d35-4f68-a27c-28af9a898733	2025-10-23	Warnings	Exact identifier unii: G2M7P15E5P
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	ICU Medical Inc.	b96eb740-749a-4d3a-ae63-b8e3947cad30	2025-10-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 660YQ98I10
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c34c1486-fa6c-485f-80b3-98e397b3dddb	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	74c078ec-a371-4406-8d5e-a0baada3a1a6	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2765f345-eab2-4878-b1f1-f8e243083476	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	d1181543-07ab-4a51-8b55-afc1a98293f6	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c7be3a7e-f031-4ec0-b9dc-41c025cd0066	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	41c0c262-21c3-b8e6-e063-6394a90a7c9c	2025-10-22	Warnings	Exact identifier unii: 15FIX9V2JP
Sonni SunDay Invisible Defense	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41ad9658-7906-d04c-e063-6394a90a4723	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
Sonni SunDay Body Balm	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41adca2e-cf69-ccd9-e063-6294a90a0dc0	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	940e0b2d-0b10-4534-ba36-e9980cead492	2025-10-21	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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