Quick answers
- What is Collagenase santyl used for?
- The FDA-approved label (Collagenase Santyl, Smith & Nephew, Inc, May 17, 2019) says: “Collagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Collagenase santyl have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Collagenase santyl?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Collagenase santyl been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Collagenase santyl?
- 1 company lists prescription products of Collagenase santyl in the FDA NDC Directory, including Smith & Nephew, Inc.
What Collagenase santyl is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Collagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21
— FDA label: Collagenase Santyl, Smith & Nephew, Inc, effective May 17, 2019. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Ointment |
|---|---|
| Route | Topical |
| Prescription products | 1 in the FDA NDC Directory |
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.
- Smith & Nephew, Inc1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA101995 SANTYL | Smith and Nephew | June 4, 1965 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0567-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30 — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 309509 |
|---|---|
| SPL set ID of the quoted label | 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd |
| FDA labels (SPL) | 1 |
| FDA applications | BLA101995 |
| Active ingredients (FDA) | COLLAGENASE CLOSTRIDIUM HISTOLYTICUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Collagenase Santyl, Smith & Nephew, Inc, effective May 17, 2019; 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 →