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Polyethylene Glycol 3350

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Polyethylene Glycol 3350
Generic name
Polyethylene Glycol 3350
Dosage form
Powder, for Solution
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Cardinal Health 107, LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
30
Packages
81
Data completeness
83% 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/1 876193 View
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
111

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@FDANDC Directory
Application number
203928
Application type
ANDA · Abbreviated New Drug Application
Approval date
August 24, 2016
Sponsor
STRIDES PHARMA
Products on application
2
Submissions recorded
4
Products approved under application 203928.
Product Trade name Form Strength Ingredient Status TE Flags
203928-001 POLYETHYLENE GLYCOL 3350 FOR SOLUTION POLYETHYLENE GLYCOL 3350 Over-the-counter —
203928-002 POLYETHYLENE GLYCOL 3350 FOR SOLUTION POLYETHYLENE GLYCOL 3350 Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 203928.
Type No. Action Status Date Review
Supplement 19 Manufacturing (CMC) Approved September 11, 2026 Unknown
Supplement 11 Labeling Approved February 8, 2023 Standard
Supplement 5 Labeling Approved February 8, 2023 Standard
Original application 1 Approved August 24, 2016 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260910). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260910 HUMAN OTC DRUG · 20260828 HUMAN OTC DRUG · 20260127 HUMAN OTC DRUG · 20250930

Recent Major Changes

openFDA Drug Labeling

Carton-100pkt

Indications and Usage

openFDA Drug Labeling

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

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

Dosage and Administration

openFDA Drug Labeling

Directions (Can 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 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 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 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 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) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line) (Packet Only) Polyethylene Glycol 3350, 17 g

In case of overdose, get medical help or contact a Poison Control Center right away.

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Polyethylene Glycol 3350 17g of white powder when filled to the indicated line (white section in cap). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep Tightly Closed Dispense in a tight, light-resistant container as defined in the USP. NDC: 72162-2172-2: 238 g Powder for Solution NDC: 72162-2172-4: 510 g Powder for Solution Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

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 June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. Terminated
Class II June 2, 2021 Cardinal Health Inc. CGMP Deviations: Intermittent exposure to temperature excursion during storage. 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
50090-2430-0 50090-2430 A-S Medication Solutions 238 g in 1 BOTTLE (50090-2430-0) July 5, 2016
62559-157-10 62559-157 ANI Pharmaceuticals, Inc. 100 PACKET in 1 CARTON (62559-157-10) / 17 g in 1 PACKET (62559-157-17) March 24, 2020
62559-157-30 62559-157 ANI Pharmaceuticals, Inc. 30 PACKET in 1 CARTON (62559-157-30) / 17 g in 1 PACKET (62559-157-17) March 24, 2020
60687-431-27 60687-431 American Health Packaging 30 POUCH in 1 CARTON (60687-431-27) / 17 g in 1 POUCH (60687-431-99) November 21, 2023
60687-431-92 60687-431 American Health Packaging 100 POUCH in 1 CARTON (60687-431-92) / 17 g in 1 POUCH (60687-431-99) February 26, 2020
60687-431-98 60687-431 American Health Packaging 14 POUCH in 1 CARTON (60687-431-98) / 17 g in 1 POUCH (60687-431-99) May 29, 2019
59651-876-25 59651-876 Aurobindo Pharma Limited 25000 g in 1 BAG (59651-876-25) April 23, 2024
84386-125-08 84386-125 Aurobindo Pharma Limited 119 g in 1 BOTTLE, PLASTIC (84386-125-08) January 7, 2026
84386-125-14 84386-125 Aurobindo Pharma Limited 14 PACKET in 1 CARTON (84386-125-14) / 17 g in 1 PACKET January 7, 2026
84386-125-24 84386-125 Aurobindo Pharma Limited 238 g in 1 BOTTLE, PLASTIC (84386-125-24) January 7, 2026
84386-125-54 84386-125 Aurobindo Pharma Limited 510 g in 1 BOTTLE, PLASTIC (84386-125-54) January 7, 2026
58602-805-01 58602-805 Aurohealth LLC 119 g in 1 BOTTLE, PLASTIC (58602-805-01) April 9, 2018
58602-805-02 58602-805 Aurohealth LLC 238 g in 1 BOTTLE, PLASTIC (58602-805-02) April 9, 2018
58602-805-03 58602-805 Aurohealth LLC 510 g in 1 BOTTLE, PLASTIC (58602-805-03) April 9, 2018
58602-805-04 58602-805 Aurohealth LLC 850 g in 1 BOTTLE, PLASTIC (58602-805-04) April 9, 2018
58602-805-25 58602-805 Aurohealth LLC 765 g in 1 BOTTLE, PLASTIC (58602-805-25) April 23, 2024
58602-805-27 58602-805 Aurohealth LLC 14 PACKET in 1 CARTON (58602-805-27) / 17 g in 1 PACKET April 23, 2024
68001-607-55 68001-607 BluePoint Laboratories 238 g in 1 BOTTLE (68001-607-55) October 1, 2023
68001-607-69 68001-607 BluePoint Laboratories 510 g in 1 BOTTLE (68001-607-69) October 1, 2023
72162-2172-2 72162-2172 Bryant Ranch Prepack 238 g in 1 BOTTLE (72162-2172-2) January 23, 2024
72162-2172-4 72162-2172 Bryant Ranch Prepack 510 g in 1 BOTTLE (72162-2172-4) January 23, 2024
72162-2180-2 72162-2180 Bryant Ranch Prepack 238 g in 1 BOTTLE (72162-2180-2) February 2, 2024
72162-2180-4 72162-2180 Bryant Ranch Prepack 510 g in 1 BOTTLE (72162-2180-4) February 2, 2024
70000-0699-2 70000-0699 CARDINAL HEALTH 110, LLC. DBA LEADER 10 PACKET in 1 CARTON (70000-0699-2) / 17 g in 1 PACKET (70000-0699-1) November 8, 2024
83324-002-08 83324-002 CHAIN DRUG MARKETING ASSOCIATION, INC. 238 g in 1 BOTTLE (83324-002-08) March 1, 2024
83324-002-16 83324-002 CHAIN DRUG MARKETING ASSOCIATION, INC. 510 g in 1 BOTTLE (83324-002-16) March 1, 2024
69230-324-32 69230-324 Camber Consumer Care Inc 7 PACKET in 1 CARTON (69230-324-32) / 17 g in 1 PACKET April 14, 2021
69230-324-33 69230-324 Camber Consumer Care Inc 10 PACKET in 1 CARTON (69230-324-33) / 17 g in 1 PACKET April 14, 2021
69230-324-34 69230-324 Camber Consumer Care Inc 119 g in 1 BOTTLE (69230-324-34) April 14, 2021
69230-324-35 69230-324 Camber Consumer Care Inc 238 g in 1 BOTTLE (69230-324-35) April 14, 2021
69230-324-36 69230-324 Camber Consumer Care Inc 510 g in 1 BOTTLE (69230-324-36) April 14, 2021
69230-324-37 69230-324 Camber Consumer Care Inc 14 PACKET in 1 CARTON (69230-324-37) / 17 g in 1 PACKET April 14, 2021
69230-324-38 69230-324 Camber Consumer Care Inc 100 PACKET in 1 CARTON (69230-324-38) / 17 g in 1 PACKET April 21, 2025
69230-324-39 69230-324 Camber Consumer Care Inc 765 g in 1 BOTTLE (69230-324-39) January 3, 2025
69230-324-40 69230-324 Camber Consumer Care Inc 40 PACKET in 1 CARTON (69230-324-40) / 17 g in 1 PACKET April 21, 2025
55154-2328-5 55154-2328 Cardinal Health 107, LLC 7 PACKET in 1 BAG (55154-2328-5) / 17 g in 1 PACKET June 30, 2019
55154-8090-5 55154-8090 Cardinal Health 107, LLC 5 POUCH in 1 BAG (55154-8090-5) / 17 g in 1 POUCH June 30, 2019
55154-8091-5 55154-8091 Cardinal Health 107, LLC 5 POUCH in 1 BAG (55154-8091-5) / 17 g in 1 POUCH June 30, 2019
55154-8184-5 55154-8184 Cardinal Health 107, LLC 7 POUCH in 1 BAG (55154-8184-5) / 17 g in 1 POUCH April 15, 2019
72657-196-16 72657-196 GLENMARK THERAPEUTICS INC., USA 765 g in 1 CAN (72657-196-16) September 19, 2024
57896-489-14 57896-489 Geri-Care Pharmaceutical Corp 238 g in 1 BOTTLE (57896-489-14) July 1, 2016
57896-489-30 57896-489 Geri-Care Pharmaceutical Corp 510 g in 1 BOTTLE (57896-489-30) July 1, 2016
57896-490-03 57896-490 Gericare Pharmaceuticals 30 PACKET in 1 CARTON (57896-490-03) / 17 g in 1 PACKET (57896-490-01) October 27, 2022
57896-490-07 57896-490 Gericare Pharmaceuticals 119 g in 1 CAN (57896-490-07) October 27, 2022
57896-490-14 57896-490 Gericare Pharmaceuticals 238 g in 1 CAN (57896-490-14) October 27, 2022
57896-490-30 57896-490 Gericare Pharmaceuticals 510 g in 1 CAN (57896-490-30) October 27, 2022
57896-490-45 57896-490 Gericare Pharmaceuticals 765 g in 1 CAN (57896-490-45) October 27, 2022
81033-762-01 81033-762 Kesin Pharma Corporation 100 PACKET in 1 CARTON (81033-762-01) / 17 g in 1 PACKET (81033-762-17) June 9, 2025
81033-762-14 81033-762 Kesin Pharma Corporation 14 PACKET in 1 CARTON (81033-762-14) / 17 g in 1 PACKET (81033-762-17) June 9, 2025
81033-762-30 81033-762 Kesin Pharma Corporation 30 PACKET in 1 CARTON (81033-762-30) / 17 g in 1 PACKET (81033-762-17) June 9, 2025
50844-772-01 50844-772 L.N.K. International, Inc. 30 PACKET in 1 CARTON (50844-772-01) / 17 g in 1 PACKET September 10, 2026
50844-772-03 50844-772 L.N.K. International, Inc. 10 PACKET in 1 CARTON (50844-772-03) / 17 g in 1 PACKET September 10, 2026
50844-772-09 50844-772 L.N.K. International, Inc. 20 PACKET in 1 CARTON (50844-772-09) / 17 g in 1 PACKET September 10, 2026
50844-772-12 50844-772 L.N.K. International, Inc. 100 PACKET in 1 CARTON (50844-772-12) / 17 g in 1 PACKET September 10, 2026
50844-772-43 50844-772 L.N.K. International, Inc. 17 g in 1 PACKET (50844-772-43) September 10, 2026
50844-772-48 50844-772 L.N.K. International, Inc. 14 PACKET in 1 CARTON (50844-772-48) / 17 g in 1 PACKET September 10, 2026
50844-772-49 50844-772 L.N.K. International, Inc. 238 g in 1 BOTTLE, PLASTIC (50844-772-49) September 10, 2026
50844-772-90 50844-772 L.N.K. International, Inc. 510 g in 1 BOTTLE, PLASTIC (50844-772-90) September 10, 2026
50844-772-92 50844-772 L.N.K. International, Inc. 119 g in 1 BOTTLE, PLASTIC (50844-772-92) September 10, 2026
50844-772-93 50844-772 L.N.K. International, Inc. 578 g in 1 BOTTLE, PLASTIC (50844-772-93) September 10, 2026
0904-6931-26 0904-6931 Major Pharmaceuticals 14 PACKET in 1 CARTON (0904-6931-26) / 17 g in 1 PACKET June 30, 2019
0904-6931-76 0904-6931 Major Pharmaceuticals 30 PACKET in 1 CARTON (0904-6931-76) / 17 g in 1 PACKET June 30, 2019
0904-6931-81 0904-6931 Major Pharmaceuticals 100 PACKET in 1 CARTON (0904-6931-81) / 17 g in 1 PACKET June 30, 2019
0904-6931-86 0904-6931 Major Pharmaceuticals 17 g in 1 PACKET (0904-6931-86) June 30, 2019
72603-302-02 72603-302 NorthStar Rx LLC 14 PACKET in 1 CARTON (72603-302-02) / 17 g in 1 PACKET (72603-302-01) April 1, 2025
72603-302-03 72603-302 NorthStar Rx LLC 30 PACKET in 1 CARTON (72603-302-03) / 17 g in 1 PACKET (72603-302-01) April 1, 2025
72603-302-04 72603-302 NorthStar Rx LLC 100 PACKET in 1 CARTON (72603-302-04) / 17 g in 1 PACKET (72603-302-01) April 1, 2025
72090-036-01 72090-036 PIONEER LIFE SCIENCES, LLC 30 PACKET in 1 CARTON (72090-036-01) / 17 g in 1 PACKET March 5, 2025
72090-036-02 72090-036 PIONEER LIFE SCIENCES, LLC 100 PACKET in 1 CARTON (72090-036-02) / 17 g in 1 PACKET March 5, 2025
72090-036-03 72090-036 PIONEER LIFE SCIENCES, LLC 10 PACKET in 1 CARTON (72090-036-03) / 17 g in 1 PACKET April 8, 2026
45802-868-01 45802-868 Padagis Israel Pharmaceuticals Ltd 119 g in 1 BOTTLE (45802-868-01) November 6, 2009
45802-868-02 45802-868 Padagis Israel Pharmaceuticals Ltd 238 g in 1 BOTTLE (45802-868-02) November 4, 2009
45802-868-03 45802-868 Padagis Israel Pharmaceuticals Ltd 510 g in 1 BOTTLE (45802-868-03) November 5, 2009
45802-868-66 45802-868 Padagis Israel Pharmaceuticals Ltd 14 PACKET in 1 CARTON (45802-868-66) / 17 g in 1 PACKET July 16, 2018
68788-8601-2 68788-8601 Preferred Pharmaceuticals Inc. 238 g in 1 BOTTLE (68788-8601-2) March 8, 2024
63739-760-04 63739-760 SKY Packaging 100 PACKET in 1 CARTON (63739-760-04) / 17 g in 1 PACKET (63739-760-01) August 1, 2024
51672-2104-3 51672-2104 Sun Pharmaceutical Industries, Inc. 765 g in 1 CAN (51672-2104-3) October 9, 2025
51672-2104-5 51672-2104 Sun Pharmaceutical Industries, Inc. 238 g in 1 CAN (51672-2104-5) July 29, 2026
51672-2104-9 51672-2104 Sun Pharmaceutical Industries, Inc. 510 g in 1 CAN (51672-2104-9) July 29, 2026
87362-119-01 87362-119 The Fresh Test, LLC 119 g in 1 CAN (87362-119-01) July 20, 2026
73581-913-40 73581-913 YYBA Corp 40 PACKET in 1 CARTON (73581-913-40) / 17 POWDER, FOR SOLUTION in 1 PACKET January 1, 2026
50090-2430 50090-2430 A-S Medication Solutions — October 13, 2009
62559-157 62559-157 ANI Pharmaceuticals, Inc. — March 24, 2020
60687-431 60687-431 American Health Packaging — May 29, 2019
59651-876 59651-876 Aurobindo Pharma Limited — April 23, 2024
84386-125 84386-125 Aurobindo Pharma Limited — January 7, 2026
58602-805 58602-805 Aurohealth LLC — April 9, 2018
68001-607 68001-607 BluePoint Laboratories — October 1, 2023
72162-2172 72162-2172 Bryant Ranch Prepack — October 13, 2009
72162-2180 72162-2180 Bryant Ranch Prepack — May 1, 2014
70000-0699 70000-0699 CARDINAL HEALTH 110, LLC. DBA LEADER — November 8, 2024
83324-002 83324-002 CHAIN DRUG MARKETING ASSOCIATION, INC. — March 1, 2024
69230-324 69230-324 Camber Consumer Care Inc — April 14, 2021
55154-2328 55154-2328 Cardinal Health 107, LLC — June 30, 2019
55154-8090 55154-8090 Cardinal Health 107, LLC — June 30, 2019
55154-8091 55154-8091 Cardinal Health 107, LLC — June 30, 2019
55154-8184 55154-8184 Cardinal Health 107, LLC — April 15, 2019
72657-196 72657-196 GLENMARK THERAPEUTICS INC., USA — September 19, 2024
57896-489 57896-489 Geri-Care Pharmaceutical Corp — May 1, 2014
57896-490 57896-490 Gericare Pharmaceuticals — October 27, 2022
81033-762 81033-762 Kesin Pharma Corporation — June 9, 2025
50844-772 50844-772 L.N.K. International, Inc. — September 10, 2026
0904-6931 0904-6931 Major Pharmaceuticals — June 30, 2019
72603-302 72603-302 NorthStar Rx LLC — April 1, 2025
72090-036 72090-036 PIONEER LIFE SCIENCES, LLC — March 5, 2025
45802-868 45802-868 Padagis Israel Pharmaceuticals Ltd — October 13, 2009
68788-8601 68788-8601 Preferred Pharmaceuticals Inc. — March 8, 2024
63739-760 63739-760 SKY Packaging — August 1, 2024
51672-2104 51672-2104 Sun Pharmaceutical Industries, Inc. — October 9, 2025
87362-119 87362-119 The Fresh Test, LLC — July 20, 2026
73581-913 73581-913 YYBA Corp — January 1, 2026

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 · 11 sections on this page.