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Prescription medicine

Sorbitol

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Sorbitol used for?
The FDA-approved label (Sorbitol, Baxter Healthcare Corporation, December 31, 2019) says: “3% 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Sorbitol have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Sorbitol?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Sorbitol been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Sorbitol?
1 company lists prescription products of Sorbitol in the FDA NDC Directory, including Baxter Healthcare Corporation.

What Sorbitol is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

3% 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.

— FDA label: Sorbitol, Baxter Healthcare Corporation, effective December 31, 2019. Read the full label on DailyMed →

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.

Forms and how it is given

Dosage formsIrrigant
RouteIrrigation
Prescription products1 in the FDA NDC Directory

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA017863
SORBITOL 3% IN PLASTIC CONTAINER
Baxter HlthcareMay 30, 1980 38, latest March 23, 2004
2004: Labeling · 2003: Labeling · 2002: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

RxCUI (RxNorm)313090
SPL set ID of the quoted labelaea0b5a1-444b-4330-a3ce-26485dbbfe75
FDA labels (SPL)1
FDA applicationsNDA017863
Active ingredients (FDA)SORBITOL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Sorbitol, Baxter Healthcare Corporation, effective December 31, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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