Active ingredient
Polyethylene Glycol 3350
105 finished FDA listings contain Polyethylene Glycol 3350 as their only active ingredient; 19 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- POLYETHYLENE GLYCOL 3350
- Dosage forms
- Powder, Powder, For Solution, Powder, For Suspension
- Routes
- Oral, Topical
- Manufacturers / labelers
- 77
- Strengths listed
- 17 g/1 · 17 g/17g · 17 g/d · 17 g/g
- Brand names in FDA listings
- 365 Whole Foods Market Polyethylene Glycol 3350, Basic Care Clearlax, Berkley And Jensen Clearlax, Care One Clearlax, Careone Clearlax, Clear Lax, Clearlax, Comfortlax, Dg Health Clearlax, Discount Drug Mart, Dulcolax, Easylax, Equaline Clearlax, Equate Clear Lax, Equate Clearlax, Exchange Select Clearlax, Ez2go Polyethylene Glycol 3350, Foster And Thrive Clearlax, Gavilax, Gentle Lax, Gentlelax, Good Neighbor Pharmacy Clearlax, Good Sense Clear Lax, Good Sense Clearlax, Injoy Constipation Relief, Kirkland Signature Laxaclear Original Prescription Strength, Kroger, Laxative, Leader Clearlax, Members Mark Clearlax, Miralax, Miralax Orange Flavor, Mix-In Laxative Packets, Peg3350, Polyethylene Glycol 3350, Polyethylene Glycol 3350 Nf, Polyethylene Glycol 3350 Powder For Solution, Purelax, Rugby Peg 3350, Signature Care Clearlax, Smooth Lax, Smoothlax, Topcare Clearlax, Up And Up Powderlax, Walgreens, Welby Clearlax, Winco
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 221147
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 022015 | BAYER HEALTHCARE LLC | 2006-10-06 | 4 |
| ANDA 090685 | PPI-DAC | 2009-10-06 | 52 |
| ANDA 091077 | NOVEL LABS INC | 2009-10-06 | 7 |
| ANDA 090812 | POINTVIEW HLDINGS | 2009-10-07 | 6 |
| ANDA 202071 | SHREE HARI INTL | 2012-12-28 | 4 |
| ANDA 202850 | ANI PHARMS | 2015-12-15 | 3 |
| ANDA 203928 | STRIDES PHARMA | 2016-08-24 | 15 |
| ANDA 206105 | NUVO PHARMS INC | 2016-10-28 | 1 |
| ANDA 209017 | AUROBINDO PHARMA LTD | 2018-04-09 | 5 |
| ANDA 214990 | ANNORA PHARMA | 2021-04-14 | 6 |
| ANDA 217505 | LNK INTL INC | 2026-07-29 | 2 |
Official labeling on DailyMed
- LEADER CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] · version 7 · 2026-09-24
- POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [L.N.K. INTERNATIONAL, INC.] · version 10 · 2026-09-11
- CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC] · version 4 · 2026-09-11
- MIX-IN LAXATIVE PACKETS (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [WAL-MART STORES INC] · version 10 · 2026-09-10
- POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [CARDINAL HEALTH 107, LLC] · version 6 · 2026-09-07
- BASIC CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC] · version 7 · 2026-09-07
- PURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY] · version 3 · 2026-09-07
- PURELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CVS PHARMACY] · version 16 · 2026-09-04
- KROGER (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [KROGER COMPANY] · version 5 · 2026-09-03
- GENTLE LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [KROGER COMPANY] · version 13 · 2026-09-02
- CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC] · version 2 · 2026-09-02
- PEG3350 (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS] · version 3 · 2026-08-31
Showing the 12 most recent of 99 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.