Quick answers
- What is Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride used for?
- The FDA-approved label (PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, Wilshire Pharmaceuticals, Inc., April 14, 2026) says: “PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 19, 2019 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride?
- 5 companies list prescription products of Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride in the FDA NDC Directory, including Strides Pharma Science Limited, Wilshire Pharmaceuticals, Inc. and Aurobindo Pharma Limited.
What Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. …
— FDA label: PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, Wilshire Pharmaceuticals, Inc., effective April 14, 2026. Read the full label on DailyMed →
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder, for solution |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | PEG 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Trilyte, Peg-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Gavilyte-N |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| polyethylene glycol 3350 420 g/4 L · potassium chloride 1.48 g/4 L · sodium bicarbonate 5.72 g/4 L · sodium chloride 11.2 g/4 L powder, for solution | Generic | $0.0043 per mL |
| polyethylene glycol 3350 420 g/438.4 g · potassium chloride 1.48 g/438.4 g · sodium bicarbonate 5.72 g/438.4 g · sodium chloride 11.2 g/438.4 g powder, for solution | Generic | $0.0043 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Strides Pharma Science Limited3 products
- Wilshire Pharmaceuticals, Inc.1 product
- Aurobindo Pharma Limited1 product
- Affordable Pharmaceuticals, LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
FDA approval history
- 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 | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019797 NULYTELY, NULYTELY-FLAVORED | Azurity | April 22, 1991 | 17, latest May 14, 2021 2021: Labeling · 2013: Labeling · 2010: Labeling |
Generic approvals (3)
- ANDA076491Aurobindo Pharma USA · February 5, 2004
- ANDA090019Novel Labs Inc · May 27, 2009
- ANDA204559Strides Pharma · April 13, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 19, 2019 · Class II · Terminated · D-1113-2019
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltim — LUPIN SOMERSET
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 801054, 904158, 979099 |
|---|---|
| SPL set ID of the quoted label | 4e442a72-b13b-4869-8a1d-59356095b091 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA019797, 3 ANDA |
| Active ingredients (FDA) | POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride, Wilshire Pharmaceuticals, Inc., effective April 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →