Prescription and over-the-counter medicine
Sorbitol
Sorbitol is a prescription and over-the-counter medicine with an FDA approval on record since 1978. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the sorbitol FDA label on DailyMed (effective December 31, 2019, Baxter Healthcare Corporation); the NDA 16741 record on Drugs@FDA; every sorbitol label on DailyMed.
Highlights of the record
FDA label of December 31, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usage3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder.
Forms and strengths
- 30 g/1000ml
Irrigant.
On the market
- Earliest approval on file
- February 16, 1978 Sorbitol 3.3% In Plastic Container, B Braun; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 598 through July 30, 2026
What is sorbitol used for?
From the label: indications and usage3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.
Source: FDA drug label (Sorbitol), Baxter Healthcare Corporation, effective December 31, 2019 (SPL set aea0b5a1-444b-4330-a3ce-26485dbbfe75), via openFDA; the full label on DailyMed
Is there a generic for sorbitol?
No generic sorbitol is approved (Drugs@FDA, October 8, 2026).
- 1978 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sorbitol?
The FDA Adverse Event Reporting System holds 598 reports that list sorbitol 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 326 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?
- Sorbitol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other