Prescription medicine
Sodium tetradecyl First approved as Sotradecol
Sodium tetradecyl (Sotradecol) is a prescription medicine with an FDA approval on record since 1946. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the sodium tetradecyl FDA label on DailyMed (effective June 26, 2024, Hikma Pharmaceuticals USA Inc.); the NDA 5970 record on Drugs@FDA; every sodium tetradecyl label on DailyMed.
Highlights of the record
FDA label of June 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSodium tetradecyl sulfate injection is indicated in the treatment of small uncomplicated varicose veins of the lower extremities that show simple dilation with competent valves.
Forms and strengths
- 30 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- August 13, 1946 Sotradecol, Elkins Sinn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first November 12, 2004; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 5 more by firms not listed as its makers
- FAERS reports
- 53 through July 30, 2026
What is sodium tetradecyl used for?
From the label: indications and usageSodium 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.
Source: FDA drug label (Sodium Tetradecyl Sulfate), Hikma Pharmaceuticals USA Inc., effective June 26, 2024 (SPL set 997394e1-ec1f-4093-e053-2a95a90a0ea0), via openFDA; the full label on DailyMed
Is there a generic for sodium tetradecyl (Sotradecol)?
The FDA approved the first generic sodium tetradecyl on November 12, 2004. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium tetradecyl from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1946 earliest approval on file
- 2004 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sodium tetradecyl been recalled?
The FDA's Enforcement Report lists 5 recalls naming sodium tetradecyl since 2013: 0 Class I (the most serious), 5 Class II, 0 Class III; 1 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of sodium tetradecyl and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2015 | Class II | JD & SN Inc., dba Moses Lake Professional Pharmacy not a listed maker | Lack of Assurance of Sterility; all sterile human compounded drugs within expiry |
| May 18, 2015 | Class II | Advanced Physician Solutions, Inc. not a listed maker | Lack of Assurance of Sterility |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| April 10, 2013 | Class II | FVS Holdings, Inc. dba. Green Valley Drugs not a listed maker | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sodium tetradecyl label say about other medicines?
The sodium tetradecyl label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name sodium tetradecyl. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | drug interactions | The physician must use judgment and evaluate any patient taking antiovulatory drugs prior to initiating treatment with sodium tetradecyl sulfate injection. (See ADVERSE REACTIONS section.) Heparin should not be included in the same syringe as sodium tetradecyl sulfate injection, since the two are incompatible. |
Other labels that name sodium tetradecyl
Source: FDA drug label (Sodium Tetradecyl Sulfate), Hikma Pharmaceuticals USA Inc., effective June 26, 2024 (SPL set 997394e1-ec1f-4093-e053-2a95a90a0ea0), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium tetradecyl?
The FDA Adverse Event Reporting System holds 53 reports that list sodium tetradecyl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 12 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sodium tetradecyl side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other