MiraLAX

Product NDC: 76420-489
11-digit product format: 764200489
Labeler code: 76420
Product ID: 76420-489_411a7a72-348c-4e5b-e063-6294a90a6c7e
Type: HUMAN OTC DRUG
Nonproprietary name: Polyethylene Glycol 3350
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: ASCLEMED USA INC.
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022015-001	MIRALAX	17GM/SCOOPFUL	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022015-002	MIRALAX	17GM/PACKET	FOR SOLUTION / ORAL	RLD, RS	2006-10-06	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: MiraLAX
Listing expiration: 2026-12-31

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
876195	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
e652042f-3707-4bf6-831d-d806638b7d85	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
76420-489-10	MiraLAX	10 in 1 CARTON	POWDER, FOR SOLUTION	10	1
76420-489-10	MiraLAX	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	1
76420-489-20	MiraLAX	20 in 1 CARTON	POWDER, FOR SOLUTION	20	1
76420-489-20	MiraLAX	17 g in 1 POUCH	POWDER, FOR SOLUTION	17	1
76420-489-24	MiraLAX	24 in 1 CARTON	POWDER, FOR SOLUTION	24	1
76420-489-24	MiraLAX	17 g in 1 PACKET	POWDER, FOR SOLUTION	17	1
76420-489-77	MiraLAX	765 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	765	1
76420-489-85	MiraLAX	850 g in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	850	1

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
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 ndc (product): 76420-489

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	e652042f-3707-4bf6-831d-d806638b7d85	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	PSN	e652042f-3707-4bf6-831d-d806638b7d85	1
876195	polyethylene glycol 3350 17000 MG Powder for Oral Solution [Miralax]	SBD	e652042f-3707-4bf6-831d-d806638b7d85	1
876193	polyethylene glycol 3350 17000 MG Powder for Oral Solution	SCD	e652042f-3707-4bf6-831d-d806638b7d85	1
876195	Miralax 17 GM Powder for Oral Solution	SY	e652042f-3707-4bf6-831d-d806638b7d85	1
876193	polyethylene glycol 3350 17 GM Powder for Oral Solution	SY	e652042f-3707-4bf6-831d-d806638b7d85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-489-10	76420048910	10 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKET	10 packet	2025-10-14	No	No	Current
76420-489-20	76420048920	20 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCH	20 pouch	2025-10-14	No	No	Current
76420-489-24	76420048924	24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET	24 packet	2025-10-14	No	No	Current
76420-489-77	76420048977	765 g in 1 BOTTLE, PLASTIC (76420-489-77)	765 g	2025-10-14	No	No	Current
76420-489-85	76420048985	850 g in 1 BOTTLE, PLASTIC (76420-489-85)	850 g	2025-10-14	No	No	Current