Polyethylene Glycol

Product NDC: 63940-762
11-digit product format: 639400762
Labeler code: 63940
Product ID: 63940-762_6b9592f2-983d-462f-90a2-c288bc8f6657
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Harmon Stores, Inc
Application: ANDA203928
Marketing category: ANDA
Marketing start: 2016-08-24
Marketing end: 0000-00-00
Substance: POLYETHYLENE GLYCOL 3350
Active strength: 17 g/17g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63940-762		I	Inactivated by FDA	2026-10-28
excluded package	package	63940-762	63940-762-03	I	Inactivated by FDA	2026-10-28
excluded package	package	63940-762	63940-762-04	I	Inactivated by FDA	2026-10-28
excluded package	package	63940-762	63940-762-05	I	Inactivated by FDA	2026-10-28

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63940-762-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63940-762-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63940-762-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63940-762-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63940-762-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63940-762-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63940-762-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63940-762-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63940-762-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63940-762-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63940-762-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63940-762-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63940-762-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63940-762-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63940-762-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63940-762-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63940-762-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63940-762-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63940-762-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63940-762-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63940-762-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63940-762-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63940-762-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63940-762-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63940-762-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63940-762-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63940-762-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63940-762-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63940-762-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63940-762-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63940-762-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63940-762-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63940-762-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63940-762-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63940-762-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63940-762-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63940-762-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63940-762-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63940-762-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63940-762-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63940-762-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63940-762-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63940-762-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63940-762-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63940-762-05	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A203928-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2016-08-24
A203928-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2016-08-24

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203928-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203928-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2016-08-24	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

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
63940-762-03	2020-01-31	C162847	48780-1	9d75b9d0-da17-f424-e053-dadaa90a57ce	Polyethylene Glycol 3350 powder for solution
63940-762-04	2020-01-31	C162847	48780-1	9d75b9d0-da17-f424-e053-dadaa90a57ce	Polyethylene Glycol 3350 powder for solution
63940-762-05	2020-01-31	C162847	48780-1	9d75b9d0-da17-f424-e053-dadaa90a57ce	Polyethylene Glycol 3350 powder for solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63940-762-03	Polyethylene Glycol	119 g in 1 BOTTLE	POWDER, FOR SOLUTION	119	1
63940-762-04	Polyethylene Glycol	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238	1
63940-762-05	Polyethylene Glycol	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63940-762	POLYETHYLENE GLYCOL POWDER, FOR SOLUTION [HARMON STORES, INC]	1	Legacy NDC, 3 package rows	20170522_3fd415b7-3d17-47ff-86b1-9eeac5f20271.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	4d524ace-9de5-4f62-9263-7cd88a36b67c	2026-08-28	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Mix-In Laxative Packets	POLYETHYLENE GLYCOL 3350	Wal-Mart Stores Inc	0347c934-1e85-4f8d-8d35-bb07f16810ad	2026-08-27	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	The Fresh Test, LLC	cb8e182f-c23f-4f8d-9c09-24e19b2e914e	2026-08-05	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	INSTALAX POLYETHYLENE GLYCOL 3350	Sun Pharmaceutical Industries, Inc.	40bd1be7-de67-8dff-e063-6294a90aca95	2026-07-24	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	4e8b6a32-11ec-4419-9ec8-aaa182389972	2026-06-19	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	PIONEER LIFE SCIENCES, LLC	478f104a-0e50-479c-8722-a3f1eab68691	2026-06-11	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene glycol 3350	POLYETHYLENE GLYCOL 3350	Major Pharmaceuticals	ddc9d2b1-87d8-44fa-bac6-0a7261f33564	2026-05-12	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
ez2go Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Valley Medical Products, LLC	d64517d6-b0cc-4ba2-b260-e52faa8d4e78	2026-02-20	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	American Health Packaging	81374641-e54c-4b41-a3ad-49b19a097666	2026-02-18	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	GLENMARK THERAPEUTICS INC., USA	5aba6bb1-d25d-4901-8e9c-4cd4a3a06471	2026-01-27	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350 Powder for Solution	POLYETHYLENE GLYCOL, UNSPECIFIED	VALLEY MEDICAL PRODUCTS, LLC	ae595e97-6d29-44f8-a647-fcd54fcda5b1	2025-10-27	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Kesin Pharma Corporation	3729a1d2-4c98-dfdf-e063-6394a90a5a87	2025-06-12	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Gericare Pharmaceuticals	5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd	2022-10-28	Warnings	Exact identifier application applno (ANDA): 203928 application number: ANDA203928

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	3fd415b7-3d17-47ff-86b1-9eeac5f20271	1
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	3fd415b7-3d17-47ff-86b1-9eeac5f20271	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	3fd415b7-3d17-47ff-86b1-9eeac5f20271	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
63940-762-03	63940076203	119 g in 1 BOTTLE	119 g	Historical
63940-762-04	63940076204	238 g in 1 BOTTLE	238 g	Historical
63940-762-05	63940076205	510 g in 1 BOTTLE	510 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polyethylene Glycol 3350 powder for solution	Harmon Stores, Inc \| Strides Shasun Limited	2017-05-04	HUMAN OTC DRUG LABEL	1