GAVILAX

Product NDC: 43386-312
11-digit product format: 433860312
Labeler code: 43386
Product ID: 43386-312_ced29c35-5d51-4eb1-8119-1c988d29a592
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA091077
Marketing category: ANDA
Marketing start: 2009-10-09
Substance: POLYETHYLENE GLYCOL 3350
Active strength: 17 g/17g
Pharmacologic classes: Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091077-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-06
A091077-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2011-06-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091077-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2011-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091077-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2011-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091077-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-06	`f41ea6bd6efb…`

Additional Listing Data#

Finished product: Yes
Brand name base: GAVILAX
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POLYETHYLENE GLYCOL 3350	17 g/17g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G2M7P15E5P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
876193	Internal RxNorm lookup
876214	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19672e23-1606-497e-a112-939af33af195	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43386-312-07	GAVILAX	119 g in 1 BOTTLE	POWDER, FOR SOLUTION	119	8
43386-312-08	GAVILAX	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238	8
43386-312-14	GAVILAX	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510	8
43386-312-85	GAVILAX	850 g in 1 BOTTLE	POWDER, FOR SOLUTION	850	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-312-08	GM - Gram	43386-312	57798290-79a3-4b31-81dc-ba4a8f41a9db	1	2012-07-24
43386-312-14	GM - Gram	43386-312	8ab2f632-0a16-4655-9b64-514a838fe0e4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PREFERRED PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [GAVIS PHARMACEUTICALS, LLC]	2
Bisacodyl	ACTIVE INGREDIENT	10X0709Y6I	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Magnesium Citrate	ACTIVE INGREDIENT	RHO26O1T9V	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Metoclopramide Hydrochloride	ACTIVE INGREDIENT	W1792A2RVD	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Polyethylene Glycol 3350	ACTIVE INGREDIENT	G2M7P15E5P	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Bisacodyl	ACTIVE MOIETY	10X0709Y6I	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Magnesium Cation	ACTIVE MOIETY	T6V3LHY838	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Metoclopramide	ACTIVE MOIETY	L4YEB44I46	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Polyethylene Glycol 3350	ACTIVE MOIETY	G2M7P15E5P	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Acacia	INACTIVE INGREDIENT	5C5403N26O	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Ammonium Nonoxynol-4 Sulfate	INACTIVE INGREDIENT	9HIA70O4J0	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Calcium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	L11K75P92J	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Calcium Sulfate Anhydrous	INACTIVE INGREDIENT	E934B3V59H	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Carnauba Wax	INACTIVE INGREDIENT	R12CBM0EIZ	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Cholecalciferol	INACTIVE INGREDIENT	1C6V77QF41	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Lemon Oil	INACTIVE INGREDIENT	I9GRO824LL	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Light Mineral Oil	INACTIVE INGREDIENT	N6K5787QVP	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Potassium Bicarbonate	INACTIVE INGREDIENT	HM5Z15LEBN	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Shellac	INACTIVE INGREDIENT	46N107B71O	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	PCP 100 KIT (MAGESIUM CITRATE, BISACODYL, PETROLATUM, POLYETHYLENE GLYCOL 3350, METOCLOPRAMIDE) KIT [ASCLEMED USA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-312	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [LUPIN PHARMACEUTICALS,INC.]	7	Current NDC, Legacy NDC, 4 package rows	20240131_19672e23-1606-497e-a112-939af33af195.zip

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAVILAX	POLYETHYLENE GLYCOL 3350	Atlantic Biologicals Corp.	4c207478-6f0f-c3cf-e063-6394a90aa4f2	2026-06-04	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077
GAVILAX	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals, Inc.	21654def-5ae0-422d-961b-1fe2456af00a	2026-05-04	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077
GAVILAX	POLYETHYLENE GLYCOL 3350	Lupin Pharmaceuticals,Inc.	19672e23-1606-497e-a112-939af33af195	2025-12-08	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077 ndc (product): 43386-312
GAVILAX	POLYETHYLENE GLYCOL 3350	ATLANTIC BIOLOGICALS CORP.	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	2025-07-22	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077
GAVILAX	POLYETHYLENE GLYCOL 3350	A-S Medication Solutions	581baa4b-7331-47a3-81c6-680286f03aca	2025-01-09	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077
GAVILAX	POLYETHYLENE GLYCOL 3350	Proficient Rx LP	199d6173-3fad-49e4-88fe-bde7223ed4c3	2022-06-01	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077
Polyethylene Glycol	POLYETHYLENE GLYCOL	BluePoint Laboratories	c4cae70c-68da-0bbc-e053-2a95a90a395a	2021-09-20	Warnings	Exact identifier application applno (ANDA): 091077 application number: ANDA091077

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876214	Gavilax 17 GM Powder for Oral Solution	SY	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	c9688f06-b6db-4afb-b8ff-ef5fb8bf9946	14
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	581baa4b-7331-47a3-81c6-680286f03aca	9
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	581baa4b-7331-47a3-81c6-680286f03aca	9
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	581baa4b-7331-47a3-81c6-680286f03aca	9
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	581baa4b-7331-47a3-81c6-680286f03aca	9
876214	Gavilax 17 GM Powder for Oral Solution	SY	581baa4b-7331-47a3-81c6-680286f03aca	9
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	581baa4b-7331-47a3-81c6-680286f03aca	9
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	19672e23-1606-497e-a112-939af33af195	8
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	19672e23-1606-497e-a112-939af33af195	8
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	19672e23-1606-497e-a112-939af33af195	8
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	19672e23-1606-497e-a112-939af33af195	8
876214	Gavilax 17 GM Powder for Oral Solution	SY	19672e23-1606-497e-a112-939af33af195	8
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	19672e23-1606-497e-a112-939af33af195	8
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	21654def-5ae0-422d-961b-1fe2456af00a	7
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	21654def-5ae0-422d-961b-1fe2456af00a	7
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	21654def-5ae0-422d-961b-1fe2456af00a	7
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	21654def-5ae0-422d-961b-1fe2456af00a	7
876214	Gavilax 17 GM Powder for Oral Solution	SY	21654def-5ae0-422d-961b-1fe2456af00a	7
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	21654def-5ae0-422d-961b-1fe2456af00a	7
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876214	Gavilax 17 GM Powder for Oral Solution	SY	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	199d6173-3fad-49e4-88fe-bde7223ed4c3	6
876214	GaviLAX 17 GM Powder for Oral Solution	PSN	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1
876214	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]	SBD	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1
876214	Gavilax 17 GM Powder for Oral Solution	SY	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	4c207478-6f0f-c3cf-e063-6394a90aa4f2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-312-07	43386031207	119 g in 1 BOTTLE (43386-312-07)	119 g	2009-10-09	0000-00-00	No	No	Current
43386-312-08	43386031208	238 g in 1 BOTTLE (43386-312-08)	238 g	2009-10-09	0000-00-00	Yes	No	Current
43386-312-14	43386031214	510 g in 1 BOTTLE (43386-312-14)	510 g	2009-10-09	0000-00-00	Yes	No	Current
43386-312-85	43386031285	850 g in 1 BOTTLE (43386-312-85)	850 g	2009-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gavilax (Polyethylene Glycol 3350)	Atlantic Biologicals Corp.	2026-06-04	HUMAN OTC DRUG LABEL	3
Drug Facts	Preferred Pharmaceuticals, Inc.	2026-05-04	HUMAN OTC DRUG LABEL	7
Drug Facts	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2025-12-08	HUMAN OTC DRUG LABEL	8
Gavilax Powder Solution Drug Facts	ATLANTIC BIOLOGICALS CORP.	2025-07-22	HUMAN OTC DRUG LABEL	14
GAVILAX	A-S Medication Solutions	2025-01-09	HUMAN OTC DRUG LABEL	9
GAVILAX	DirectRX	2023-09-11	HUMAN PRESCRIPTION DRUG LABEL	6
Drug Facts	Proficient Rx LP	2022-06-01	HUMAN OTC DRUG LABEL	6
Drug Facts	Preferred Pharmaceuticals, Inc.	2019-09-30	HUMAN OTC DRUG LABEL	4
PCP 100 Kit - Asclemed USA, Inc.	Asclemed USA, Inc.	2017-06-14	HUMAN PRESCRIPTION DRUG LABEL	4