Quick answers
- What is Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride used for?
- The FDA-approved label (GoLYTELY, Azurity Pharmaceuticals, Inc., April 15, 2026) says: “GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults.” 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 sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, 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 sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 27, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride?
- 8 companies list prescription products of Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., A-S Medication Solutions and Strides Pharma Science Limited.
What Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. GoLYTELY is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults.
— FDA label: GoLYTELY, Azurity Pharmaceuticals, Inc., effective April 15, 2026. Read the full label on DailyMed →
The FDA has 8 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 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Powder, for solution |
|---|---|
| Route | Oral |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Peg-3350 and Electrolytes, Golytely, PEG 3350 and Electrolytes, Gavilyte G Tm, Polyethylene Glycol 3350 and Electrolyteswith Orange Flavor, Gavilyte - C Tm |
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 236 g/274.31 g · potassium chloride 2.97 g/274.31 g · sodium bicarbonate 6.74 g/274.31 g · sodium chloride 5.86 g/274.31 g · sodium sulfate anhydrous 22.74 g/274.31 g powder, for solution | Generic | $0.0047 per mL |
| polyethylene glycol 3350 236 g/4 L · potassium chloride 2.97 g/4 L · sodium bicarbonate 6.74 g/4 L · sodium chloride 5.86 g/4 L · sodium sulfate anhydrous 22.74 g/4 L powder, for solution | Generic | $0.0047 per mL |
| polyethylene glycol 3350 236 g/4 L · potassium chloride 2.97 g/4 L · sodium bicarbonate 6.74 g/4 L · sodium chloride 5.86 g/4 L · sodium sulfate anhydrous 22.74 g/4 L powder, for solution | Brand: GoLYTELY | $0.0060 per mL |
| polyethylene glycol 3350 240 g/278.26 g · potassium chloride 2.98 g/278.26 g · sodium bicarbonate 6.72 g/278.26 g · sodium chloride 5.84 g/278.26 g · sodium sulfate anhydrous 22.72 g/278.26 g powder, for solution | Generic | $0.0040 per mL |
NADAC list of November 4, 2026; these prices took effect between September 2, 2026 and 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.
- Lupin Pharmaceuticals, Inc.2 products
- A-S Medication Solutions2 products
- Strides Pharma Science Limited2 products
- Novel Laboratories, Inc.1 product
- Braintree Laboratories, Inc.1 product
- Wilshire Pharmaceuticals, Inc.1 product
- Azurity Pharmaceuticals, Inc.1 product
- Affordable Pharmaceuticals, LLC1 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 |
|---|---|---|---|
| NDA019011 GOLYTELY | Azurity | July 13, 1984 | 20, latest May 14, 2021 2021: Labeling · 2020: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (3)
- ANDA090186Novel Labs Inc · June 1, 2009
- ANDA090231Novel Labs Inc · June 1, 2009
- ANDA204558Strides Pharma · December 21, 2018
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.
-
April 27, 2022 · Class II · Terminated · D-0875-2022
Failed Stability Specification
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19 — Lupin Pharmaceuticals Inc.
-
July 29, 2021 · Class II · Terminated · D-0726-2021
Failed Stability Specification; Out of specification for Osmolarity
GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 ND — Novel Laboratories, Inc. d.b.a LUPIN
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — GoLYTELY, Azurity Pharmaceuticals, Inc., effective April 15, 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 →