MiraLAX — Powder, for Solution

Overview

Brand name

MiraLAX

Generic name

Polyethylene Glycol 3350

Dosage form

Powder, for Solution

Route

Oral

Marketing category

NDA · NDA

Labeler

Bayer HealthCare LLC.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

4

Packages

14

Data completeness

77% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Polyethylene Glycol 3350	17 g/17g	876193	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Powder, for Solution

Route of administration

Oral

Presentations

18

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Osmotic Activity [MoA]	MoA	All 105 members
Osmotic Laxative [EPC]	EPC	All 103 members
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]	PE	All 53 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

022015

Application type

NDA · New Drug Application

Approval date

October 6, 2006

Sponsor

BAYER HEALTHCARE LLC

Products on application

2

Submissions recorded

28

Products approved under application 022015.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
022015-001	MIRALAX	FOR SOLUTION		POLYETHYLENE GLYCOL 3350	Over-the-counter	—	RLD RS
022015-002	MIRALAX	FOR SOLUTION		POLYETHYLENE GLYCOL 3350	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 022015.
Type	No.	Action	Status	Date	Review
Supplement	50	Labeling	Approved	February 3, 2025	Standard
Supplement	48	Labeling	Approved	September 18, 2023	Standard
Supplement	47	Labeling	Approved	July 27, 2023	Standard
Supplement	46	Labeling	Approved	June 20, 2023	Standard
Supplement	45	Labeling	Approved	March 23, 2023	Standard
Supplement	43	Labeling	Approved	July 5, 2022	Standard
Supplement	40	Labeling	Approved	April 27, 2021	Standard
Supplement	35	Labeling	Approved	June 3, 2019	Standard
Supplement	34	Labeling	Approved	October 12, 2018	Standard
Supplement	33	Labeling	Approved	August 17, 2018	Standard
Supplement	30	Labeling	Approved	May 4, 2018	Standard
Supplement	29	Labeling	Approved	April 24, 2018	Standard
Supplement	27	Labeling	Approved	October 4, 2017	Standard
Supplement	26	Labeling	Approved	October 21, 2016	Standard
Supplement	25	Labeling	Approved	September 30, 2016	Standard
Supplement	24	Labeling	Approved	November 12, 2015	Standard
Supplement	23	Labeling	Approved	October 29, 2015	Standard
Supplement	18	Manufacturing (CMC)	Approved	September 24, 2015	Standard
Supplement	22	Manufacturing (CMC)	Approved	July 14, 2015	Standard
Supplement	20	Manufacturing (CMC)	Approved	August 3, 2014	Standard
Supplement	19	Manufacturing (CMC)	Approved	March 5, 2014	Standard
Supplement	17	Manufacturing (CMC)	Approved	October 22, 2013	Standard
Supplement	16	Manufacturing (CMC)	Approved	January 4, 2013	Standard
Supplement	12	Labeling	Approved	March 15, 2012	Standard
Supplement	6	Labeling	Approved	May 5, 2010	Standard
Supplement	3	Manufacturing (CMC)	Approved	December 2, 2008	N/A
Supplement	2	Manufacturing (CMC)	Approved	November 20, 2008	N/A
Original application	1	Type 8 - Partial Rx to OTC Switch	Approved	October 6, 2006	Standard

Review documents

0 · Supplement · September 30, 2025
0 · Supplement · February 7, 2025
0 · Supplement · October 31, 2023
0 · Supplement · September 19, 2023
0 · Supplement · July 31, 2023
0 · Supplement · July 28, 2023
0 · Supplement · June 21, 2023
0 · Supplement · June 21, 2023
0 · Supplement · March 24, 2023
0 · Supplement · March 24, 2023
0 · Supplement · July 6, 2022
0 · Supplement · July 5, 2022
0 · Supplement · May 14, 2021
0 · Supplement · April 28, 2021
0 · Supplement · June 5, 2019
0 · Supplement · June 5, 2019
0 · Supplement · October 17, 2018
0 · Supplement · October 15, 2018
0 · Supplement · August 27, 2018
0 · Supplement · August 20, 2018
0 · Supplement · May 8, 2018
0 · Supplement · May 8, 2018
0 · Supplement · May 3, 2018
0 · Supplement · April 27, 2018
0 · Supplement · October 18, 2017
0 · Supplement · October 6, 2017
0 · Supplement · October 27, 2016
0 · Supplement · October 25, 2016
0 · Supplement · October 11, 2016
0 · Supplement · October 5, 2016

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251107). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251107 HUMAN OTC DRUG · 20251014

Indications and Usage

openFDA Drug Labeling

Use • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Purpose

openFDA Drug Labeling

Purpose Osmotic Laxative

Dosage and Administration

openFDA Drug Labeling

Directions (Bottle Only) • do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) • adults and children 17 years of age and older: o use once a day o fill to top of white section in cap which is marked to indicate the correct dose (17 g) o stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink o do not combine with starch-based thickeners used for difficulty swallowing o ensure that the powder is fully dissolved before drinking o do not drink if there are any clumps o do not use no more than 7 days • children 16 years of age or under: ask a doctor

Directions (Packet Only) • do not take more than directed unless advised by your doctor • adults and children 17 years of age and older: o use once a day o stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink o do not combine with starch-based thickeners used for difficulty swallowing o ensure that the powder is fully dissolved before drinking o do not drink if there are any clumps o do not use more than 7 days • children 16 years of age or under: ask a doctor

Warnings

openFDA Drug Labeling

Warnings Allergy alert Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if • you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do Not Use

openFDA Drug Labeling

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each dose) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line)

Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g

Adverse event reports

Source: openFDA FAERS

100,281

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: POLYETHYLENE GLYCOL 3350. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class II	August 17, 2022	Mckesson Medical-Surgical Inc. Corporate Office	CGMP Deviations: products were stored outside the drug label specifications.	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
76420-489-10	76420-489	ASCLEMED USA INC.	10 PACKET in 1 CARTON (76420-489-10) / 17 g in 1 PACKET	October 14, 2025
76420-489-20	76420-489	ASCLEMED USA INC.	20 POUCH in 1 CARTON (76420-489-20) / 17 g in 1 POUCH	October 14, 2025
76420-489-24	76420-489	ASCLEMED USA INC.	24 PACKET in 1 CARTON (76420-489-24) / 17 g in 1 PACKET	October 14, 2025
76420-489-77	76420-489	ASCLEMED USA INC.	765 g in 1 BOTTLE, PLASTIC (76420-489-77)	October 14, 2025
76420-489-85	76420-489	ASCLEMED USA INC.	850 g in 1 BOTTLE, PLASTIC (76420-489-85)	October 14, 2025
11523-4357-2	11523-4357	Bayer HealthCare LLC.	2 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKET	February 1, 2007
11523-4357-3	11523-4357	Bayer HealthCare LLC.	2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) / 578 g in 1 BOTTLE, PLASTIC	February 1, 2007
11523-4357-5	11523-4357	Bayer HealthCare LLC.	24 PACKET in 1 CARTON (11523-4357-5) / 17 g in 1 PACKET	May 1, 2018
11523-7268-3	11523-7268	Bayer HealthCare LLC.	10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET	February 1, 2007
11523-7268-4	11523-7268	Bayer HealthCare LLC.	765 g in 1 BOTTLE, PLASTIC (11523-7268-4)	February 1, 2007
11523-7268-5	11523-7268	Bayer HealthCare LLC.	850 g in 1 BOTTLE, PLASTIC (11523-7268-5)	May 30, 2025
11523-7268-8	11523-7268	Bayer HealthCare LLC.	24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET	February 1, 2007
11523-7268-9	11523-7268	Bayer HealthCare LLC.	20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH	February 1, 2007
55154-5035-6	55154-5035	Cardinal Health 107, LLC	6 PACKET in 1 BAG (55154-5035-6) / 17 g in 1 PACKET	February 23, 2009
76420-489	76420-489	ASCLEMED USA INC.	—	February 1, 2007
11523-4357	11523-4357	Bayer HealthCare LLC.	—	February 1, 2007
11523-7268	11523-7268	Bayer HealthCare LLC.	—	February 1, 2007
55154-5035	55154-5035	Cardinal Health 107, LLC	—	February 23, 2009

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts
Enforcement	FDA	Recall records

Generated September 25, 2026 · 12 sections on this page.