Good Neighbor Pharmacy ClearLax — Powder, for Solution

Overview

Brand name

Good Neighbor Pharmacy ClearLax

Generic name

Polyethylene Glycol 3350

Dosage form

Powder, for Solution

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Amerisource Bergen

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

5

Data completeness

76% 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

7

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

090685

Application type

ANDA · Abbreviated New Drug Application

Approval date

October 6, 2009

Sponsor

PPI-DAC

Products on application

2

Submissions recorded

8

Products approved under application 090685.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
090685-001	POLYETHYLENE GLYCOL 3350	FOR SOLUTION		POLYETHYLENE GLYCOL 3350	Over-the-counter	—
090685-002	POLYETHYLENE GLYCOL 3350	FOR SOLUTION		POLYETHYLENE GLYCOL 3350	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 090685.
Type	No.	Action	Status	Date	Review
Supplement	19	Manufacturing (CMC)	Approved	August 18, 2026	Unknown
Supplement	14	Manufacturing (CMC)	Approved	June 16, 2022	Unknown
Supplement	13	Labeling	Approved	October 13, 2021	Standard
Supplement	11	Labeling	Approved	October 13, 2021	Standard
Supplement	9	Manufacturing (CMC)	Approved	October 11, 2019	Unknown
Supplement	3	Labeling	Approved	January 12, 2016	Standard
Supplement	2	Labeling	Approved	February 6, 2013	—
Original application	1		Approved	October 6, 2009	—

Review documents

0 · Original application · October 14, 2009

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250417). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250417 HUMAN OTC DRUG · 20230215

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 • 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: • use once a day • fill to top of white section in cap which is marked to indicate the correct dose (17 g) • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink • do not combine with starch-based thickeners used for difficulty swallowing • ensure that the powder is fully dissolved before drinking • do not drink if there are any clumps • do not use no 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 or 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 your nausea, bloating, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 your nausea, bloating, 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) Polyethylene Glycol 3350, 17 g (cap filled to line)

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.

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
46122-014-31	46122-014	Amerisource Bergen	119 g in 1 BOTTLE (46122-014-31)	October 19, 2009
46122-014-33	46122-014	Amerisource Bergen	238 g in 1 BOTTLE (46122-014-33)	October 20, 2009
46122-014-52	46122-014	Amerisource Bergen	10 PACKET in 1 CARTON (46122-014-52) / 17 g in 1 PACKET	September 6, 2016
46122-014-71	46122-014	Amerisource Bergen	510 g in 1 BOTTLE (46122-014-71)	October 27, 2009
46122-805-29	46122-805	Amerisource Bergen	238 g in 1 BOTTLE (46122-805-29)	March 21, 2025
46122-014	46122-014	Amerisource Bergen	—	October 19, 2009
46122-805	46122-805	Amerisource Bergen	—	March 21, 2025

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

Generated September 25, 2026 · 10 sections on this page.