Polyethylene Gycol 3350

Product NDC: 69168-473
11-digit product format: 691680473
Labeler code: 69168
Product ID: 69168-473_3f5e8be5-96ac-462d-94b1-d8caaac1bf3a
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Gycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Allegiant Health
Application: ANDA214990
Marketing category: ANDA
Marketing start: 2025-03-17
Substance: POLYETHYLENE GLYCOL 3350
Active strength: 17 g/g
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
A214990-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2021-04-14
A214990-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2021-04-14

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.

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	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214990-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214990-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214990-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2021-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214990-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2021-04-14	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Polyethylene Gycol 3350
Listing expiration: 2026-12-31

Active Ingredients#

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

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
13851c9a-a226-481b-9db5-bc7053997df7	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
69168-473-55	Polyethylene Gycol 3350	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510	1
69168-473-56	Polyethylene Gycol 3350	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238	1
69168-473-61	Polyethylene Gycol 3350	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238	1
69168-473-62	Polyethylene Gycol 3350	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
69168-473	POLYETHYLENE GYCOL 3350 POWDER, FOR SOLUTION [ALLEGIANT HEALTH]	1	Current NDC, 4 package rows	20250321_13851c9a-a226-481b-9db5-bc7053997df7.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
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	YYBA Corp	48488531-5d04-4af6-e063-6294a90afe4b	2026-01-13	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Preferred Pharmaceuticals Inc.	cccbe459-813d-4668-8cd2-76be82906a32	2025-09-09	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Camber Consumer Care Inc	b321a7f5-f80b-4a51-9fd9-2c21fc1cae9b	2025-04-23	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990
Polyethylene Gycol 3350	POLYETHYLENE GYCOL 3350	Allegiant Health	13851c9a-a226-481b-9db5-bc7053997df7	2025-03-17	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990 ndc (product): 69168-473
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	CHAIN DRUG MARKETING ASSOCIATION, INC.	901a1918-87bb-47c2-a465-8c468c3a1ee5	2024-03-26	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	BluePoint Laboratories	02e36812-53c2-003b-e063-6394a90aed12	2024-01-31	Warnings	Exact identifier application applno (ANDA): 214990 application number: ANDA214990

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	13851c9a-a226-481b-9db5-bc7053997df7	1
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	13851c9a-a226-481b-9db5-bc7053997df7	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	13851c9a-a226-481b-9db5-bc7053997df7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69168-473-55	69168047355	510 g in 1 BOTTLE (69168-473-55)	510 g	2025-03-17	No	No	Current
69168-473-56	69168047356	238 g in 1 BOTTLE (69168-473-56)	238 g	2025-03-17	No	No	Current
69168-473-61	69168047361	238 g in 1 BOTTLE (69168-473-61)	238 g	2025-03-17	No	No	Current
69168-473-62	69168047362	510 g in 1 BOTTLE (69168-473-62)	510 g	2025-03-17	No	No	Current