Quick answers
- What is Dimethyl sulfoxide used for?
- The FDA-approved label (Rimso-50, Mylan Institutional LLC, March 17, 2021) says: “RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dimethyl sulfoxide have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dimethyl sulfoxide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dimethyl sulfoxide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dimethyl sulfoxide?
- 2 companies list prescription products of Dimethyl sulfoxide in the FDA NDC Directory, including Mylan Institutional LLC and Renova Pharmaceuticals LLC.
What Dimethyl sulfoxide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.
— FDA label: Rimso-50, Mylan Institutional LLC, effective March 17, 2021. Read the full label on DailyMed →
The FDA has 2 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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Irrigant |
|---|---|
| Route | Intravesical |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Rimso-50 |
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.
- Mylan Institutional LLC1 product
- Renova Pharmaceuticals 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 |
|---|---|---|---|
| NDA017788 RIMSO-50 | Mylan Institutional | April 4, 1978 | 11, latest August 27, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Generic approvals (1)
- ANDA220173Pharmobedient · July 7, 2026
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
| RxCUI (RxNorm) | 208361, 562359 |
|---|---|
| SPL set ID of the quoted label | 58b25d79-78f2-4953-b0c6-61658dc4ef0d |
| FDA labels (SPL) | 2 |
| FDA applications | NDA017788, 1 ANDA |
| Active ingredients (FDA) | DIMETHYL SULFOXIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Rimso-50, Mylan Institutional LLC, effective March 17, 2021; 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 →