GAVILAX

Product NDC: 63187-368
11-digit product format: 631870368
Labeler code: 63187
Product ID: 63187-368_f28b44fb-7018-43ee-9d1b-c8d6bdcb7894
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Proficient Rx LP
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
199d6173-3fad-49e4-88fe-bde7223ed4c3	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	Strength	SPL version
63187-368-23	GAVILAX	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-368	GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [PROFICIENT RX LP]	6	Current NDC, Legacy NDC, 1 package rows	20220602_199d6173-3fad-49e4-88fe-bde7223ed4c3.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
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 ndc (product): 63187-368
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-368-23	63187036823	238 g in 1 BOTTLE (63187-368-23)	238 g	2016-09-01	0000-00-00	No	No	Current