Prescription medicine
Polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride Brand names: Trilyte, Gavilyte-N; first approved as Nulytely
Polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride (Nulytely) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $0.0046 per mL (Peg 3350-electrolyte solution) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride FDA label on DailyMed (effective April 14, 2026, Wilshire Pharmaceuticals, Inc.); the NDA 19797 record on Drugs@FDA; every polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride label on DailyMed.
Highlights of the record
FDA label of April 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePEG-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.
Forms and strengths
- 420 g / 11.2 g / 5.72 g / 1.48 g
- 420 g / 5.72 g / 11.2 g / 1.48 g
- 420 g/438.4g / 11.2 g/438.4g / 5.72 g/438.4g / 1.48 g/438.4g
Powder for solution.
On the market
- Earliest approval on file
- April 22, 1991 Nulytely, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first February 5, 2004; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0046 per mL Peg 3350-electrolyte solution
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 0 Class I among all firms' recalls; latest March 19, 2019
- FAERS reports
- 392 through July 30, 2026
What is polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride used for?
From the label: indications and usagePEG-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. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater
FDA pharmacologic class: Osmotic Laxative and Potassium Salt.
Source: FDA drug label (PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride), NDA019797 (Azurity), as published by Wilshire Pharmaceuticals, Inc., effective April 14, 2026 (SPL set 4e442a72-b13b-4869-8a1d-59356095b091), via openFDA; the full label on DailyMed
Is there a generic for polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride (Nulytely)?
The FDA approved the first generic polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride on February 5, 2004. 6 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, sodium bicarbonate and sodium chloride from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 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, potassium chloride, sodium bicarbonate and sodium chloride (Nulytely)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0046 per mL (Peg 3350-electrolyte solution), down 12% from $0.0052 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-electrolyte solution (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gavilyte-n solution | Generic | $0.0046 per mL | n/a | -12% |
| Peg 3350-electrolyte solution | Generic | $0.0046 per mL | n/a | -12% |
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, sodium bicarbonate and sodium chloride been recalled?
The FDA's Enforcement Report lists 1 recall naming polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride since 2019: 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 |
|---|---|---|---|
| March 19, 2019 | Class II | LUPIN SOMERSET | Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride label say about other medicines?
The polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride 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 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution. |
Source: FDA drug label (PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride), NDA019797 (Azurity), as published by Wilshire Pharmaceuticals, Inc., effective April 14, 2026 (SPL set 4e442a72-b13b-4869-8a1d-59356095b091), via openFDA; the full label on DailyMed
What do FAERS reports show for polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride?
The FDA Adverse Event Reporting System holds 392 reports that list polyethylene glycol 3350, potassium chloride, sodium bicarbonate and sodium chloride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 123 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.
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, sodium bicarbonate and sodium chloride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other