Quick answers
- What is MiraLAX?
- MiraLAX is a brand name of Polyethylene glycol 3350, an over-the-counter medicine. The FDA NDC Directory lists 5 MiraLAX products in 1 strength and form.
- Who makes MiraLAX?
- Bayer Healthcare LLC holds the FDA application for MiraLAX (NDA022015, approved October 6, 2006). 2 other companies (repackagers or distributors) also list MiraLAX products.
- Is there a generic or store brand of MiraLAX?
- Yes. The FDA NDC Directory lists 94 other products with the same active ingredients, strength and form as a MiraLAX product, 94 of them generic or store brands. Ask your pharmacist whether one is right for you.
- Has MiraLAX been recalled?
- FDA enforcement reports list 1 recall of MiraLAX products; the newest started June 29, 2022. A recall usually concerns specific lots, not every product.
What MiraLAX is
Each MiraLAX product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Polyethylene glycol 3350 · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| polyethylene glycol 3350 17 g/17 g powder, for solution (oral) | MiraLAX, MiraLAX Orange Flavor | 94 products, 62 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Polyethylene glycol 3350 →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022015 | Bayer Healthcare LLC | October 6, 2006 | 4 |
| ANDA090685 | Ppi-Dac | October 6, 2009 | 1 |
Companies that list MiraLAX
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of MiraLAX products.
- Bayer HealthCare LLC.3 products
- Asclemed USA Inc.1 product
- Cardinal Health 107, LLC1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 29, 2022 · Class II · Terminated · D-1319-2022
CGMP Deviations: products were stored outside the drug label specifications.
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4. — Mckesson Medical-Surgical Inc. Corporate Office
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.