CLEARLAX

Product NDC: 70677-1068
11-digit product format: 706771068
Labeler code: 70677
Product ID: 70677-1068_374e2998-0c02-c804-e063-6394a90a67c4
Type: HUMAN OTC DRUG
Nonproprietary name: polyethylene glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: STRATEGIC SOURCING SERVICES LLC
Application: ANDA090812
Marketing category: ANDA
Marketing start: 2023-08-01
Marketing end: 2026-12-31
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70677-1068	70677-1068-2	D	Discontinued by firm		2026-08-10

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: CLEARLAX

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
880407	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
041157b8-476c-e7d2-e063-6394a90ac3a0	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
70677-1068-1	CLEARLAX	238 g in 1 BOTTLE	POWDER, FOR SOLUTION	238		2
70677-1068-2	CLEARLAX	510 g in 1 BOTTLE	POWDER, FOR SOLUTION	510		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70677-1068-1	GM - Gram	70677-1068	78cd0d06-ad43-4f3f-9a92-94daff08f8fc	1	2023-09-05
70677-1068-2	GM - Gram	70677-1068	e7ce7be6-9876-43c9-a51e-dd1af895ac1a	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70677-1068	CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [STRATEGIC SOURCING SERVICES LLC]	1	Current NDC, 2 package rows	20230830_041157b8-476c-e7d2-e063-6394a90ac3a0.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
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 ndc (product): 70677-1068
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
880407	ClearLax 17 GM Powder for Oral Solution	PSN	041157b8-476c-e7d2-e063-6394a90ac3a0	2
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	041157b8-476c-e7d2-e063-6394a90ac3a0	2
880407	polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]	SBD	041157b8-476c-e7d2-e063-6394a90ac3a0	2
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	041157b8-476c-e7d2-e063-6394a90ac3a0	2
880407	ClearLax 17 GM Powder for Oral Solution	SY	041157b8-476c-e7d2-e063-6394a90ac3a0	2
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	041157b8-476c-e7d2-e063-6394a90ac3a0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70677-1068-1	70677106801	238 g in 1 BOTTLE (70677-1068-1)	238 g	2023-08-01	2026-12-31	No	No	Historical
70677-1068-2	70677106802	510 g in 1 BOTTLE (70677-1068-2)	510 g	2023-08-01	2026-06-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FOS peg 489	STRATEGIC SOURCING SERVICES LLC \| Geri-Care Pharmaceutical Corp	2025-06-11	HUMAN OTC DRUG LABEL	2