Over-the-counter medicine
Polyethylene glycol 3500
Polyethylene glycol 3500 is an over-the-counter medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Over the counter
Check it at the source: the polyethylene glycol 3500 FDA label on DailyMed (effective April 8, 2026, Mylan Institutional Inc.); every polyethylene glycol 3500 label on DailyMed.
Highlights of the record
FDA label of April 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagerelieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days
Forms and strengths
- 17 g/17g
Powder for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,335 through July 30, 2026
What is polyethylene glycol 3500 used for?
From the label: indications and usagerelieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days
Conditions named in the indications of polyethylene glycol 3500's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Polyethylene Glycol (3350)), Mylan Institutional Inc., effective April 8, 2026 (SPL set 219bcbc4-b84a-4209-9f34-ef2b0ef0d273), via openFDA; the full label on DailyMed
Is there a generic for polyethylene glycol 3500?
No generic polyethylene glycol 3500 is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists polyethylene glycol 3500 from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for polyethylene glycol 3500?
The FDA Adverse Event Reporting System holds 12,335 reports that list polyethylene glycol 3500 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,195 are coded as a death and 4,025 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as polyethylene glycol 3500?
15 other medicines are given the same way (oral) and in the same FDA class as polyethylene glycol 3500 or labeled mainly for the same use (constipation), the same class first. Constipation lists all 20 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Docusate | Constipation | none listed | $0.0276 per unit 100 mg softgel | No current entry |
| Sennosides | Constipation | none listed | $0.0258 per tablet 8.6 mg tablet | No current entry |
| Polyethylene glycol 3350 | Constipation | 73 labelers | $0.0286 per gram 3350 powd | No current entry |
| Bisacodyl | Constipation | none listed | $0.0441 per tablet 5 mg tablet | No current entry |
| Magnesium hydroxide | Constipation | none listed | $0.0095 per mL Milk of magnesia suspension | No current entry |
| Magnesium citrate | Constipation | none listed | $0.0066 per mL Magnesium citrate solution | No current entry |
| Lubiprostone | Constipation | 10 labelers | $0.651 per capsule 24 mcg capsule | No current entry |
| Prucalopride | Constipation | 18 labelers | $0.639 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as polyethylene glycol 3500
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to polyethylene glycol 3500
- 15 medicines for the same use
- Polyethylene glycol 3500 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other