Active substance
Polyethylene glycol 3350
- US FDA 21
- Health Canada 12
- US price lines 18
- Safety 8
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MIRALAX | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | BAYER HEALTHCARE LLC | Over-the-counter | 6 Oct 2006 |
| POLYETHYLENE GLYCOL 3350 | 17GM/PACKET; 17GM/SCOOPFUL | for solution · oral | MYLAN | Over-the-counter | 6 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/PACKET; 17GM/SCOOPFUL | for solution · oral | PPI-DAC | Over-the-counter | 6 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | NOVEL LABS INC | Over-the-counter | 6 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | POINTVIEW HLDINGS | Over-the-counter | 7 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | SHREE HARI INTL | Over-the-counter | 28 Dec 2012 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | ANI PHARMS | Over-the-counter | 15 Dec 2015 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | STRIDES PHARMA | Over-the-counter | 24 Aug 2016 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | NUVO PHARMS INC | Over-the-counter | 28 Oct 2016 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | AUROBINDO PHARMA LTD | Over-the-counter | 9 Apr 2018 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | ANNORA PHARMA | Over-the-counter | 14 Apr 2021 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL; 17GM/PACKET | for solution · oral | LNK INTL INC | Over-the-counter | 29 Jul 2026 |
| MIRALAX | 17GM/SCOOPFUL | for solution · oral | BRAINTREE | Discontinued | 18 Feb 1999 |
| GLYCOLAX | 17GM/SCOOPFUL | for solution · oral | LANNETT CO INC | Discontinued | 2 Jul 2004 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | TEVA PHARMS | Discontinued | 4 May 2006 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | PADDOCK LLC | Discontinued | 24 May 2006 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | BRECKENRIDGE PHARM | Discontinued | 26 May 2006 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | NEXGEN PHARMA INC | Discontinued | 27 Sep 2006 |
| GLYCOLAX | 17GM/PACKET; 17GM/SCOOPFUL | for solution · oral | LANNETT CO INC | Discontinued | 6 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | PADDOCK LLC | Discontinued | 15 Oct 2009 |
| POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | for solution · oral | STRIDES PHARMA INTL | Discontinued | 31 Jan 2013 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| CLEARLAX | 02324989 | 100 % | POWDER FOR SOLUTION · ORAL | PERRIGO INTERNATIONAL |
| COLAXOR | 02450070 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | MANTRA PHARMA INC |
| COMFILAX | 02460297 | 100 % | POWDER FOR SOLUTION · ORAL | CELLCHEM PHARMACEUTICALS INC. |
| EMOLAX | 02374137 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | JAMP PHARMA CORPORATION |
| HYDRALAX | 02473119 | 17 G / DOSE | POWDER FOR SOLUTION · ORAL | LSL MEDPLUS INC |
| LAX-A-DAY | 02317680 | 100 % | POWDER FOR SOLUTION · ORAL | PENDOPHARM DIVISION OF PHARMASCIENCE INC |
| LAX-A-DAY PHARMA | 02453193 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | PHARMASCIENCE INC |
| LAXATIVE | 02548933 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | PHARMASCIENCE INC |
| PEG 3350 | 02358034 | 100 % | POWDER FOR SOLUTION · ORAL | MEDISCA PHARMACEUTIQUE INC |
| PEG 3350 | 02520796 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | ANGITA PHARMA INC. |
| RELAXA | 02346672 | 100 % | POWDER FOR SOLUTION · ORAL | MEDEXUS PHARMACEUTICALS INC. |
| RESTORALAX | 02318164 | 100 % / W/W | POWDER FOR SOLUTION · ORAL | BAYER INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CLEARLAX POWDER | $0.02859 | per GM | 23 Sep 2026 |
| US NADAC | CLEARLAX POWDER | $0.02412 | per GM | 23 Sep 2026 |
| US NADAC | CLEARLAX POWDER | $0.02037 | per GM | 23 Sep 2026 |
| US NADAC | CLEARLAX POWDER PACKET | $1.22444 | per EA | 23 Sep 2026 |
| US NADAC | FT CLEARLAX POWDER | $0.02859 | per GM | 23 Sep 2026 |
| US NADAC | FT CLEARLAX POWDER | $0.02412 | per GM | 23 Sep 2026 |
| US NADAC | FT CLEARLAX POWDER | $0.02037 | per GM | 23 Sep 2026 |
| US NADAC | FT CLEARLAX POWDER | $0.01422 | per GM | 23 Sep 2026 |
| US NADAC | FT LAXATIVE EC 5 MG TABLET | $0.04406 | per EA | 23 Sep 2026 |
| US NADAC | GNP CLEARLAX POWDER | $0.02412 | per GM | 23 Sep 2026 |
| US NADAC | GS CLEARLAX POWDER | $0.02859 | per GM | 23 Sep 2026 |
| US NADAC | GS CLEARLAX POWDER | $0.02412 | per GM | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 8 Sep 2023 PLENVU — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 6 Apr 2022 MOVIPREP — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 GOLYTELY — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 COLYTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 COLYTE WITH FLAVOR PACKS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 COLYTE-FLAVORED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 NULYTELY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 NULYTELY-FLAVORED — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.