Quick answers
- What is Tetradecyl hydrogen sulfate (ester) used for?
- The FDA-approved label (Sotradecol, Mylan Institutional LLC, August 17, 2021) says: “Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tetradecyl hydrogen sulfate (ester) have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tetradecyl hydrogen sulfate (ester)?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tetradecyl hydrogen sulfate (ester) been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tetradecyl hydrogen sulfate (ester)?
- 2 companies list prescription products of Tetradecyl hydrogen sulfate (ester) in the FDA NDC Directory, including Mylan Institutional LLC and HF Acquisition Co LLC, DBA HealthFirst.
What Tetradecyl hydrogen sulfate (ester) is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Sotradecol (sodium tetradecyl sulfate injection) is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves. The benefit-to-risk ratio should be considered in selected patients who are great surgical risks.
— FDA label: Sotradecol, Mylan Institutional LLC, effective August 17, 2021. Read the full label on DailyMed →
The FDA has 3 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 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Sotradecol |
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 LLC2 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA040541Mylan Institutional · November 12, 2004
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) | 204490, 204491, 543732, 543739 |
|---|---|
| SPL set ID of the quoted label | f1756c28-dcd2-4b49-be62-07ca20682018 |
| FDA labels (SPL) | 3 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | TETRADECYL HYDROGEN SULFATE (ESTER) |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Sotradecol, Mylan Institutional LLC, effective August 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 →