Prescription medicine
Mannitol and sorbitol Brand names: Sorbitol-Mannitol
Mannitol and sorbitol (Sorbitol-Mannitol) is a prescription medicine with an FDA approval on record since 1976. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the mannitol and sorbitol FDA label on DailyMed (effective October 30, 2025, ICU Medical Inc.); the NDA 17636 record on Drugs@FDA; every mannitol and sorbitol label on DailyMed.
Highlights of the record
FDA label of October 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
Forms and strengths
- 2.7 g/100ml / 0.54 g/100ml
Irrigant.
On the market
- Earliest approval on file
- June 21, 1976 Sorbitol-Mannitol In Plastic Container, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first August 20, 1971; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
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
- 1 through July 30, 2026
What is mannitol and sorbitol used for?
From the label: indications and usageSorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures.
FDA pharmacologic class: Osmotic Diuretic.
Source: FDA drug label (Sorbitol-Mannitol), NDA018316 (Otsuka Icu Medcl), as published by ICU Medical Inc., effective October 30, 2025 (SPL set 5b44e248-4b7b-4777-954a-921c7b309944), via openFDA; the full label on DailyMed
Is there a generic for mannitol and sorbitol (Sorbitol-Mannitol)?
The FDA approved the first generic mannitol and sorbitol on August 20, 1971. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1976 earliest approval on file
- 1971 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for mannitol and sorbitol?
The FDA Adverse Event Reporting System holds 1 report that list mannitol and sorbitol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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 diuretics
- the pharmacologic class, with prices and generics
- Mannitol and sorbitol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other