Prescription medicine
Mechlorethamine Brand names: Valchlor; first approved as Mustargen
Mechlorethamine (Valchlor) is a prescription medicine with an FDA approval on record since 1949. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the mechlorethamine FDA label on DailyMed (effective November 20, 2024, Helsinn Therapeutics (U.S.), Inc.); the NDA 6695 record on Drugs@FDA; every mechlorethamine label on DailyMed.
Highlights of the record
FDA label of November 20, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
Forms and strengths
- 0.012 g/60g
Gel.
On the market
- Earliest approval on file
- March 15, 1949 Mustargen, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- Last listed patent
- July 8, 2029 Valchlor gel; not a generic launch date
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
- 2,244 through July 30, 2026
What is mechlorethamine used for?
From the label: indications and usageVALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy ( 1 ).
Conditions named in the indications of mechlorethamine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (VALCHLOR), Helsinn Therapeutics (U.S.), Inc., effective November 20, 2024 (SPL set 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57), via openFDA; the full label on DailyMed
What does the patient leaflet for mechlorethamine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VALCHLOR?Keep VALCHLOR away from your eyes, mouth, and nose. If VALCHLOR gets in your eyes it can cause eye pain, burning, swelling, redness, sensitivity to light, and blurred vision. It may also cause blindness and permanent injury to your eyes. If VALCHLOR gets in your eyes, rinse your eyes right away for at least 15 minutes with a large amount of water, normal saline, or an eye wash solution. If VALCHLOR gets in your mouth or nose it can cause pain, redness, and ulcers. Rinse the affected area right away for at least 15 minutes with a large amount of water. Get medical help right away if VALCHLOR gets in your eyes, mouth, or nose. Talk with your healthcare provider before using VALCHLOR about how to get medical help.
From the patient leaflet: What should I avoid while using VALCHLOR?VALCHLOR is flammable. Avoid fire, flame, and smoking until VALCHLOR has dried.
From the patient leaflet: How should I store VALCHLOR?Store VALCHLOR in the refrigerator between 36°F to 46°F (2°C to 8°C). Keep VALCHLOR away from food in the refrigerator. With clean hands, place VALCHLOR back in the box it came in and return it to the refrigerator right after each use. Talk with your pharmacist before you use VALCHLOR that has been out of the refrigerator for more than one hour a day. Safely throw away VALCHLOR that is not used after 90 days. Unused VALCHLOR, empty tubes, and used disposable nitrile gloves should be safely thrown away in household trash. Keep VALCHLOR and all medicines out of the reach of children.
Source: FDA drug label (VALCHLOR), Helsinn Therapeutics (U.S.), Inc., effective November 20, 2024 (SPL set 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57), via openFDA; the full label on DailyMed
Is there a generic for mechlorethamine (Valchlor)?
No generic mechlorethamine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Valchlor gel, the last expiring on July 8, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1949 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mechlorethamine label say about other medicines?
The mechlorethamine label names no other medicine on this site. The labels of 1 other medicine name mechlorethamine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (VALCHLOR), Helsinn Therapeutics (U.S.), Inc., effective November 20, 2024 (SPL set 6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57), via openFDA; the full label on DailyMed
What do FAERS reports show for mechlorethamine?
The FDA Adverse Event Reporting System holds 2,244 reports that list mechlorethamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 154 are coded as a death and 248 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?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Mechlorethamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other