EasyLAX

Product NDC: 63941-489
Requested package NDC: 63941-489-14
11-digit product format: 639410489
Labeler code: 63941
Product ID: 63941-489_4615c684-e866-c269-e063-6294a90aa451
Type: HUMAN OTC DRUG
Nonproprietary name: polyethylene glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: VALU MERCHANDISERS COMPANY
Application: ANDA090812
Marketing category: ANDA
Marketing start: 2018-01-01
Marketing end: 2027-03-31
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
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090812-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2009-10-07

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 · 41 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	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090812-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2009-10-07	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: EasyLAX

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
876193	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
6597811b-6471-5afd-e053-2991aa0a07c2	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63941-489-14	2021-12-14	C162847	48780-1	c7ccaba7-2133-fd44-e053-dadaa90aa01b	BC PEG
63941-489-14	2021-07-23	C162847	48780-1	c7ccaba7-2133-fd44-e053-dadaa90aa01b	BC PEG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63941-489-14	EasyLAX	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
63941-489	EASYLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [VALU MERCHANDISERS COMPANY]	5	Current NDC, Legacy NDC, 1 package rows	20241208_6597811b-6471-5afd-e053-2991aa0a07c2.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EasyLAX	POLYETHYLENE GLYCOL 3350	VALU MERCHANDISERS COMPANY	6597811b-6471-5afd-e053-2991aa0a07c2	2025-12-16	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812 ndc (package): 63941-489-14 ndc (product): 63941-489 ndc11 (package): 63941048914
CLEARLAX	POLYETHYLENE GLYCOL 3350	STRATEGIC SOURCING SERVICES LLC	041157b8-476c-e7d2-e063-6394a90ac3a0	2025-06-11	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812
Polyethylene Glycol 3350, NF Powder for Solution, Laxative	POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE	Pharmaceutica North America, Inc.	d048111f-8144-4d51-a0c2-a967b2bce455	2025-03-04	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	Bryant Ranch Prepack	66276671-0ccd-4c32-a697-31e679fce0e3	2024-02-06	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812
Polyethylene Glycol 3350, NF Powder for Solution, Laxative	POLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVE	LGM PHARMA SOLUTIONS, LLC	d78bead5-ff19-4d45-9003-ec131f1f5a13	2024-01-17	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	Geri-Care Pharmaceutical Corp	f4c7eb80-d8d5-406d-90d0-9d17914d71f2	2022-11-24	Warnings	Exact identifier application applno (ANDA): 090812 application number: ANDA090812

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
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	6597811b-6471-5afd-e053-2991aa0a07c2	6
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	6597811b-6471-5afd-e053-2991aa0a07c2	6
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	6597811b-6471-5afd-e053-2991aa0a07c2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63941-489-14	63941048914	238 g in 1 BOTTLE (63941-489-14)	238 g	2018-01-01	2027-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BC PEG	VALU MERCHANDISERS COMPANY \| Geri-Care Pharmaceutical Corp	2025-12-16	HUMAN OTC DRUG LABEL	6