COMFORTLAX

Product NDC: 55319-056
11-digit product format: 553190056
Labeler code: 55319
Product ID: 55319-056_92049a0c-1ad7-4741-b82f-93995f3b96a3
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Family Dollar Stores, LLC
Application: ANDA209017
Marketing category: ANDA
Marketing start: 2024-09-04
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209017-001	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL			2018-04-09
A209017-002	POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL			2024-04-23

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 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209017-002	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL	2024-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209017-001	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL	2018-04-09	`3bdfa0b2c4d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: COMFORTLAX
Listing expiration: 2027-12-31

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
2695451	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
02a44a41-0039-f6ec-e063-6394a90ae6f1	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
55319-056-24	COMFORTLAX	119 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	119	4
55319-056-27	COMFORTLAX	510 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	510	4
55319-056-33	COMFORTLAX	238 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	238	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-056	COMFORTLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [FAMILY DOLLAR STORES, LLC]	3	Current NDC, 3 package rows	20250327_02a44a41-0039-f6ec-e063-6394a90ae6f1.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
365 WHOLE FOODS MARKET Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Whole Foods Market, Inc.	b19f42a9-18ac-4d23-87b5-3c43e47c4054	2026-06-05	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
POLYETHYLENE GLYCOL 3350	POLYETHYLENE GLYCOL 3350	CARDINAL HEALTH 110, LLC. DBA LEADER	04cc4f2e-1725-4710-8cfb-73a6bdf52e4f	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurobindo Pharma Limited	b51f2223-8266-4d6c-bf32-58e53e73b54d	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017
COMFORTLAX	POLYETHYLENE GLYCOL 3350	Family Dollar Stores, LLC	02a44a41-0039-f6ec-e063-6394a90ae6f1	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017 ndc (product): 55319-056
Polyethylene Glycol 3350	POLYETHYLENE GLYCOL 3350	Aurohealth LLC	d3c77f3f-57aa-4e2d-88aa-731cbb22af70	2026-04-23	Warnings	Exact identifier application applno (ANDA): 209017 application number: ANDA209017

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
2695451	COMFORTLAX 17 GM Powder for Oral Solution	PSN	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
2695451	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Comfortlax]	SBD	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
2695451	Comfortlax 17 GM Powder for Oral Solution	SY	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
2695451	Comfortlax 17000 MG Powder for Oral Solution	SY	02a44a41-0039-f6ec-e063-6394a90ae6f1	4
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	02a44a41-0039-f6ec-e063-6394a90ae6f1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55319-056-24	55319005624	119 g in 1 BOTTLE, PLASTIC (55319-056-24)	119 g	2024-09-04	No	No	Current
55319-056-27	55319005627	510 g in 1 BOTTLE, PLASTIC (55319-056-27)	510 g	2024-09-04	No	No	Current
55319-056-33	55319005633	238 g in 1 BOTTLE, PLASTIC (55319-056-33)	238 g	2024-09-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Polyethylene Glycol 3350 Powder for Oral Solution	Family Dollar Stores, LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED \| Aurobindo Pharma Limited	2026-04-23	Human OTC Drug Label	4