Over-the-counter medicine
Polyethylene glycol 3350 Brand names: Miralax
Polyethylene glycol 3350 (Miralax) is an over-the-counter medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 69 generic labelers, and pharmacies paid $0.0286 per gram (Polyethylene glycol 3350 powd) in the October 7, 2026 NADAC survey.
- Generic listed
- Over the counter
Check it at the source: the polyethylene glycol 3350 FDA label on DailyMed (effective May 4, 2026, Bayer HealthCare LLC.); the NDA 20698 record on Drugs@FDA; every polyethylene glycol 3350 label on DailyMed.
Highlights of the record
FDA label of May 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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
- 17 g/17g
- 17 g/g
Powder for solution; powder for suspension; powder.
On the market
- Earliest approval on file
- February 18, 1999 Miralax, Braintree; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first July 2, 2004; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 70 of which 69 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0286 per gram Polyethylene glycol 3350 powd
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2018 0 Class I among all firms' recalls; latest June 29, 2022
- FAERS reports
- 105,254 through July 30, 2026
What is polyethylene glycol 3350 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 3350's FDA labels, with every medicine labeled for each:
From other polyethylene glycol 3350 labelsConstipation: Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days
FDA pharmacologic class: Osmotic Laxative.
Source: FDA drug label (MiraLAX), Bayer HealthCare LLC., effective May 4, 2026 (SPL set d69ce3d4-7ca4-4fe3-b49e-6655e48d6963), via openFDA; the full label on DailyMed
Is there a generic for polyethylene glycol 3350 (Miralax)?
The FDA approved the first generic polyethylene glycol 3350 on July 2, 2004. 19 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists polyethylene glycol 3350 from 69 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1999 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for polyethylene glycol 3350 (Miralax)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0286 per gram (Polyethylene glycol 3350 powd), down 1% from $0.029 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Polyethylene glycol 3350 powd (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clearlax powder | Generic | $0.0241 per gram | n/a | -3% |
| Clearlax powder packet | Generic | $1.22 per packet | n/a | +4% |
| Ft clearlax powder | Generic | $0.0222 per gram | n/a | -10% |
| Gavilax powder | Generic | $0.0222 per gram | n/a | -0.8% |
| Gnp clearlax powder | Generic | $0.0241 per gram | n/a | -3% |
| Gs clearlax powder | Generic | $0.0241 per gram | n/a | -3% |
| Healthylax powder packet | Generic | $1.22 per packet | n/a | +4% |
| Instalax powder | Generic | $0.0142 per gram | n/a | n/a |
| Polyethylene glycol 3350 powd | Generic | $0.0286 per gram | n/a | -1% |
| Qc laxative peg 3350 powder | Generic | $0.0222 per gram | n/a | -0.8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has polyethylene glycol 3350 been recalled?
The FDA's Enforcement Report lists 4 recalls naming polyethylene glycol 3350 since 2018: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 29, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations: products were stored outside the drug label specifications. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for polyethylene glycol 3350?
The FDA Adverse Event Reporting System holds 105,254 reports that list polyethylene glycol 3350 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,591 are coded as a death and 27,167 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 3350?
16 other medicines are given the same way (oral) and in the same FDA class as polyethylene glycol 3350 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 |
|---|---|---|---|---|
| Magnesium sulfate | Constipation | none listed | $0.0039 per gram Epsom salt | No current entry |
| Lactulose | Constipation | 22 labelers | $8.22 per packet 10 g packet | No current entry |
| Sodium phosphate dibasic and sodium phosphate monobasic | Constipation | 1 labeler | n/a | No current entry |
| 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 |
| 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 |
Every medicine labeled for the same conditions as polyethylene glycol 3350
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does polyethylene glycol 3350 compare with medicines for the same use?
5 side-by-side pages set polyethylene glycol 3350 beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to polyethylene glycol 3350
- 16 medicines for the same use
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Polyethylene glycol 3350 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other