MiraLAX

Product NDC: 11523-7234
Requested package NDC: 11523-7234-1
11-digit product format: 115237234
Labeler code: 11523
Product ID: 11523-7234_51040c1b-71bf-bb83-e063-6294a90aca4e
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Bayer HealthCare LLC.
Application: NDA022015
Marketing category: NDA
Marketing start: 2007-02-01
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

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	11523-7234	11523-7234-1	I	Inactivated by FDA		2026-08-07

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
N022015-001	MIRALAX	POLYETHYLENE GLYCOL 3350	17GM/SCOOPFUL	FOR SOLUTION / ORAL		RLD, RS	2006-10-06
N022015-002	MIRALAX	POLYETHYLENE GLYCOL 3350	17GM/PACKET	FOR SOLUTION / ORAL		RLD, RS	2006-10-06

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`f41ea6bd6efb…`

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, Related label table
NDC	Related label
11523-7234-1	MiraLAX ®
11523-7234-2	MiraLAX ®
11523-7234-3	MiraLAX ®
11523-7234-4	MiraLAX ®
11523-7234-5	MiraLAX ®
11523-7234-6	MiraLAX ®
11523-7234-9	MiraLAX ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11523-7234-1	MiraLAX	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	24
11523-7234-2	MiraLAX	119 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	119	24
11523-7234-3	MiraLAX	238 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	238	24
11523-7234-4	MiraLAX	510 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	510	24
11523-7234-5	MiraLAX	12 in 1 CARTON	POWDER, FOR SOLUTION	12	24
11523-7234-5	MiraLAX	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	24
11523-7234-6	MiraLAX	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	24
11523-7234-9	MiraLAX	510 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	510	24
11523-7234-9	MiraLAX	2 in 1 CELLO PACK	POWDER, FOR SOLUTION	2	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11523-7234-1	EA - Each	11523-7234	55e271fb-6c6f-421d-b6e4-954923124264	1	2016-09-02
11523-7234-2	GM - Gram	11523-7234	a9425dbc-97ad-4f69-a459-59186636a12e	1	2012-07-24
11523-7234-3	GM - Gram	11523-7234	d96b225f-ad80-4062-98ba-8bc9bc60e7a7	1	2012-07-24
11523-7234-4	GM - Gram	11523-7234	5c8972d7-9975-4673-9f12-300366b38457	1	2012-07-24
11523-7234-5	EA - Each	11523-7234	8360e484-598b-49ed-a4a4-084273195d55	1	2012-07-24
11523-7234-9	GM - Gram	11523-7234	6758025b-2d46-43e2-9d60-c4ff4e5a025d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Polyethylene Glycol 3350	ACTIVE INGREDIENT	G2M7P15E5P	MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]	9
Polyethylene Glycol 3350	ACTIVE MOIETY	G2M7P15E5P	MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MSD CONSUMER CARE, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11523-7234	MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]	22	Current NDC, Legacy NDC, 9 package rows	20241208_d69ce3d4-7ca4-4fe3-b49e-6655e48d6963.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MiraLAX	POLYETHYLENE GLYCOL 3350	Bayer HealthCare LLC.	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	2026-05-04	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015 ndc (package): 11523-7234-1 ndc (product): 11523-7234 ndc11 (package): 11523723401
MiraLAX	POLYETHYLENE GLYCOL 3350	Cardinal Health 107, LLC	1771d3bf-954d-49ea-b260-3d356e5dcfa5	2025-11-07	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015
MiraLAX	POLYETHYLENE GLYCOL 3350	ASCLEMED USA INC.	e652042f-3707-4bf6-831d-d806638b7d85	2025-10-14	Warnings	Exact identifier application applno (NDA): 022015 application number: NDA022015

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
876195	MiraLAX 17 GM Powder for Oral Solution	PSN	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24
876195	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]	SBD	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24
876195	Miralax 17 GM Powder for Oral Solution	SY	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	d69ce3d4-7ca4-4fe3-b49e-6655e48d6963	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11523-7234-1	11523723401	17 g in 1 PACKET (11523-7234-1)	17 g	2007-02-01	0000-00-00	No	No	Current