Quick answers
- What is Mannitol used for?
- The FDA-approved label (Osmitrol, Baxter Healthcare Company, August 26, 2025) says: “OSMITROL is indicated for: • The reduction of intracranial pressure and treatment of cerebral edema; • The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mannitol have a boxed warning?
- No. None of the 8 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Mannitol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mannitol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mannitol?
- 8 companies list prescription products of Mannitol in the FDA NDC Directory, including Baxter Healthcare Company, ICU Medical Inc. and B. Braun Medical Inc..
What Mannitol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OSMITROL is indicated for: • The reduction of intracranial pressure and treatment of cerebral edema; • The reduction of elevated intraocular pressure. OSMITROL is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure.
— FDA label: Osmitrol, Baxter Healthcare Company, effective August 26, 2025. Read the full label on DailyMed →
The FDA has 8 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 9 in the FDA NDC Directory |
| Brand names | Osmitrol |
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.
- Baxter Healthcare Company2 products
- ICU Medical Inc.1 product
- B. Braun Medical Inc.1 product
- Henry Schein, Inc.1 product
- ProPharma Distribution1 product
- HF Acquisition Co LLC, DBA HealthFirst1 product
- Hospira, Inc.1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA013684 OSMITROL 10% IN WATER, OSMITROL 10% IN WATER IN PLASTIC CONTAINER, OSMITROL 15% IN WATER, OSMITROL 15% IN WATER IN PLASTIC CONTAINER, OSMITROL 20% IN WATER, OSMITROL 20% IN WATER IN PLASTIC CONTAINER | Baxter Hlthcare | June 8, 1964 | 77, latest August 5, 2019 2019: Labeling · 2018: Labeling · 2018: Efficacy |
| NDA016269 MANNITOL 10%, MANNITOL 15%, MANNITOL 20%, MANNITOL 25%, MANNITOL 5% | Hospira | December 22, 1967 | 34, latest March 17, 2020 2020: Efficacy · 2019: Labeling · 2015: Manufacturing (CMC) |
| NDA019603 MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL 5% IN PLASTIC CONTAINER | Otsuka Icu Medcl | January 8, 1987 | 18, latest April 29, 2020 2020: Efficacy · 2019: Labeling · 2000: Manufacturing (CMC) |
| NDA020006 MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL 5% IN PLASTIC CONTAINER | B Braun | July 26, 1993 | 7, latest September 24, 2019 2019: Efficacy · 2019: Labeling · 2005: Labeling |
Generic approvals (1)
- ANDA080677Fresenius Kabi USA · August 11, 1972
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Osmitrol, Baxter Healthcare Company, effective August 26, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →