Prescription medicine
Polyethylene glycol 3350, potassium chloride and 3 other ingredients Brand names: Golytely, Gavilyte
Polyethylene glycol 3350, potassium chloride and 3 other ingredients (Golytely) is a prescription medicine with an FDA approval on record since 1984. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.0046 per mL (Peg-3350 and electrolytes solution) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the polyethylene glycol 3350, potassium chloride and 3 other ingredients FDA label on DailyMed (effective April 15, 2026, Azurity Pharmaceuticals, Inc.); the NDA 19011 record on Drugs@FDA; every polyethylene glycol 3350, potassium chloride and 3 other ingredients label on DailyMed.
Highlights of the record
FDA label of April 15, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.
Forms and strengths
- 236 g / 22.74 g / 6.74 g / 5.86 g / 2.97 g
- 236 g/274.31g / 22.74 g/274.31g / 6.74 g/274.31g / 5.86 g/274.31g / 2.97 g/274.31g
- 240 g/278.26g / 5.84 g/278.26g / 2.98 g/278.26g / 6.72 g/278.26g / 22.72 g/278.26g
Powder for solution.
On the market
- Earliest approval on file
- July 13, 1984 Golytely, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first April 20, 1988; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 8 of which 3 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0046 per mL Peg-3350 and electrolytes solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2022 0 Class I among all firms' recalls; latest April 27, 2022
- FAERS reports
- 2,262 through July 30, 2026
What is polyethylene glycol 3350, potassium chloride and 3 other ingredients used for?
From the label: indications and usageGoLYTELY 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 pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (GoLYTELY), Azurity Pharmaceuticals, Inc., effective April 15, 2026 (SPL set 7609ecf7-0ce0-4fbb-9c27-30987f689575), via openFDA; the full label on DailyMed
What does the patient leaflet for polyethylene glycol 3350, potassium chloride and 3 other ingredients say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about GoLYTELY?GoLYTELY and other osmotic bowel preparations can cause serious side effects, including: Serious loss of body fluid (dehydration) and changes in blood salts (electrolytes) in your blood. These changes can cause: abnormal heartbeats (arrhythmias) that can cause death. seizures. This can happen even if you have never had a seizure. kidney problems. Your chance of having fluid loss and changes in body salts with GoLYTELY is higher if you: have heart problems. have kidney problems. take water pills or non-steroidal anti-inflammatory drugs (NSAIDS). Tell your healthcare provider right away if you have any of these symptoms of a loss of too much body fluid (dehydration) while taking GoLYTELY: vomiting that prevents you from keeping down the solution. dizziness. urinating less often than normal. headache. See Section “What are the possible side effects of GoLYTELY” for more information about side effects. What is GoLYTELY? GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. It is not known if GoLYTELY is safe and effective in children. Who should not take GoLYTELY? Do not take GoLYTELY if your healthcare provider has told you that you have: a blockage in your bowel (obstruction). an opening in the wall of your stomach or intestine (bowel perforation). a very dilated intestine (toxic megacolon). problems with food and fluid emptying from your stomach (gastric retention). a problem with food moving too slowly through your intestines (ileus). an allergy to any of the ingredients in GoLYTELY. […]
From the patient leaflet: How should I store GoLYTELY?Store GoLYTELY in a sealed container at room temperature, between 59ºF to 86°F (15ºC to 30°C). • Store mixed (reconstituted) solution of GoLYTELY at 36° to 46°F (2°C to 8°C). Do not freeze. • Use mixed (reconstituted) solution of GoLYTELY within 48 hours. • After 48 hours, throw away (discard) any mixed (reconstituted) solution of GoLYTELY that is not used. Keep GoLYTELY and all medicines out of the reach of children.
Source: FDA drug label (GoLYTELY), Azurity Pharmaceuticals, Inc., effective April 15, 2026 (SPL set 7609ecf7-0ce0-4fbb-9c27-30987f689575), via openFDA; the full label on DailyMed
Is there a generic for polyethylene glycol 3350, potassium chloride and 3 other ingredients (Golytely)?
The FDA approved the first generic polyethylene glycol 3350, potassium chloride and 3 other ingredients on April 20, 1988. 10 generic applications are approved; 3 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, potassium chloride and 3 other ingredients from 3 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1984 earliest approval on file
- 1988 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, potassium chloride and 3 other ingredients (Golytely)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0046 per mL (Peg-3350 and electrolytes solution), up 4% from $0.0045 on October 8, 2025. 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.
- Peg-3350 and electrolytes solution (generic)
- Golytely solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gavilyte-c solution | Generic | $0.0039 per mL | n/a | +7% |
| Gavilyte-g solution | Generic | $0.0046 per mL | n/a | +4% |
| Peg-3350 and electrolytes solution | Generic | $0.0046 per mL | n/a | +4% |
| Golytely solution | Brand | $0.006 per mL | n/a | no change |
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, potassium chloride and 3 other ingredients been recalled?
The FDA's Enforcement Report lists 1 recall naming polyethylene glycol 3350, potassium chloride and 3 other ingredients since 2022: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 27, 2022 | Class II | Lupin Pharmaceuticals Inc. | Failed Stability Specification |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the polyethylene glycol 3350, potassium chloride and 3 other ingredients label say about other medicines?
The polyethylene glycol 3350, potassium chloride and 3 other ingredients label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bisacodyl | drug interactions | Avoid use of stimulant laxatives (e.g., bisacodyl, sodium picosulfate) while taking GoLYTELY [see Warnings and Precautions ( 5.5 )]. |
Check polyethylene glycol 3350, potassium chloride and 3 other ingredients against other medicines
Source: FDA drug label (GoLYTELY), Azurity Pharmaceuticals, Inc., effective April 15, 2026 (SPL set 7609ecf7-0ce0-4fbb-9c27-30987f689575), via openFDA; the full label on DailyMed
What do FAERS reports show for polyethylene glycol 3350, potassium chloride and 3 other ingredients?
The FDA Adverse Event Reporting System holds 2,262 reports that list polyethylene glycol 3350, potassium chloride and 3 other ingredients among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 115 are coded as a death and 554 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 next?
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Polyethylene glycol 3350, potassium chloride and 3 other ingredients side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other