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COLLAGENASE SANTYL 250 [arb'U]/g Ointment — NDC 50484-0010-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COLLAGENASE SANTYL 250 [arb'U]/g Ointment — NDC 50484-010-30 (Billing 50484-0010-30)

by SMITH & NEPHEW, INC · 1 TUBE in 1 CARTON / 30 g in 1 TUBE

This is a package of COLLAGENASE SANTYL 250 [arb'U]/g Ointment from SMITH & NEPHEW, INC, marketed since Oct 2006 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 50484-0010-30
🏷️ FDA NDC (as labeled) 50484-010-30 billing pads the product segment with a zero
This package
Contains30 g in 1 tube Pack sizes2 compare ↓
Also priced by: Part D plans $10.68/unit — full pricing hub ↓
Main listing for product 50484-010 · Also comes in: 90 g 50484-010-90
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 50484-010-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50484 labeler · 010 product · 30 package
Package marketed since
Oct 18, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0350484010300
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50484-010-30
Product NDC 50484-010
11-digit billing NDC 50484001030
NCPDP billing unit GM — per gram (weight)
RxCUI 309509
UNII 9X7O8V25IT
UPC 0350484010300
Application # BLA101995
SPL Set ID 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd
Established class (EPC) Collagen-specific Enzyme
Chemical class Collagenases
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-10-18
Route TOPICAL
Dosage form OINTMENT
Substance COLLAGENASE CLOSTRIDIUM HISTOLYTICUM
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90700010004205
GPI class Santyl
GCN Seq No 005258
GCN 21190
HICL code 002159
Ingredient (HICL) Collagenase Clostridium Hist.
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L0
Therapeutic class — intermediate (HIC2) Act On Subcutaneous/Connective Tissue
HIC3 code L0B
Therapeutic class — specific (HIC3) Topical/Mucous Membr./Subcut. Enzymes
AHFS code 44:00.00.00
AHFS class Enzymes
FDB label name SANTYL OINTMENT
FDB brand name Santyl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005258
  • GCN: 21190
  • GPI-14 (Medi-Span): 90700010004205
  • HICL (First Databank): 002159
  • AHFS class code: 44:00.00.00
  • RxCUI (RxNorm): 309509
Why two NDCs? The FDA registers this code as 50484-010-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50484-0010-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Collagen-specific Enzyme class.

Pharmacologic class Collagen-specific Enzyme
Drug family (ATC) Proteolytic enzymes
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name SANTYL OINTMENT Ingredient Collagenase Clostridium Hist.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $10.68 $320.36 / 30 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50484-0010-30 You're viewing this Main listing 1 TUBE in 1 CARTON / 30 g in 1 TUBE 2006-10-18 — Active
50484-0010-90 50484-010-90 1 TUBE in 1 CARTON / 90 g in 1 TUBE 2014-03-10 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of COLLAGENASE SANTYL 250 [arb'U]/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Collagenase Santyl 250 [arb'U]/gthis 50484-0010-30 SMITH 1 tube — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
1965
First FDA approval
Jun 1965
📍
2026
Currently FDA-listed
61 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerSMITH & NEPHEW, INC
FDA applicationBLA101995 (BLA)
Labeler code50484
First marketedOct 2006
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

INDICATIONS AND USAGE 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

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Collagenase Santyl ◊ Ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). When clinically indicated, crosshatching thick eschar with a #10 blade allows Collagenase Santyl ◊ Ointment more surface contact with necrotic debris. It is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily.

Use Collagenase Santyl ◊ Ointment in the following manner: 1 - Prior to application the wound should be cleansed of debris and digested material by gently rubbing with a gauze pad saturated with normal saline solution, or with the desired cleansing agent compatible with Collagenase Santyl ◊ Ointment (See PRECAUTIONS ), followed by a normal saline solution rinse. 2 - Whenever infection is present, it is desirable to use an appropriate topical antibiotic powder. The antibiotic should be applied to the wound prior to the application of Collagenase Santyl ◊ Ointment.

Should the infection not respond, therapy with Collagenase Santyl ◊ Ointment should be discontinued until remission of the infection. 3 - Collagenase Santyl ◊ Ointment may be applied directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured. 4 - Use of Collagenase Santyl ◊ Ointment should be terminated when debridement of necrotic tissue is complete and granulation tissue is well established.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Collagenase Santyl ◊ Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

🤒 Adverse Reactions 47 words ▾

ADVERSE REACTIONS No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. However, one case of systemic manifestations of hypersensitivity to collagenase in a patient treated for more than one year with a combination of collagenase and cortisone has been reported.

🆘 Overdosage 33 words ▾

OVERDOSAGE No systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. If deemed necessary the enzyme may be inactivated by washing the area with povidone iodine.

🧬 Clinical Pharmacology 128 words ▾

CLINICAL PHARMACOLOGY Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly effective in the removal of detritus. 1 Collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas. 2, 3, 4, 5, 6 Collagen in healthy tissue or in newly formed granulation tissue is not attacked.

2, 3, 4, 5, 6, 7, 8 There is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier.

📦 How Supplied / Storage and Handling ~2 min read ▾

HOW SUPPLIED Collagenase Santyl ◊ Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP. Do not store above 25°C (77°F). Sterility guaranteed until tube is opened.

Collagenase Santyl ◊ Ointment is available in the following sizes: 30 g tube NDC 50484-010-30 90 g tube NDC 50484-010-90 REFERENCES 1 – Mandl, I., Adv Enzymol. 23:163, 1961. 2 – Boxer, A.M., Gottesman, N., Bernstein, H., & Mandl, I., Geriatrics.

24:75, 1969. 3 – Mazurek, I., Med. Welt.

22:150, 1971. 4 – Zimmermann, WE., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p.

185. 5 – Vetra, H., & Whittaker, D., Geriatrics. 30:53, 1975.

6 – Rao, D.B., Sane, P.G., & Georgiev, E.L., J. Am. Geriatrics Soc.

23:22, 1975. 7 – Vrabec, R., Moserova, J., Konickova, Z., Behounkova, E., & Blaha, J., J. Hyg.

Epidemiol. Microbiol. Immunol.

18:496, 1974. 8 – Lippmann, H.I., Arch. Phys.

Med. Rehabil. 54:588, 1973.

9 – German, F. M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165.

10 – Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 177. 11 – Lee, L.K., & Ambrus, J.L., Geriatrics.

30:91, 1975. 12 – Locke, R.K., & Heifitz, N.M., J. Am.

Pod. Assoc. 65:242, 1975.

13 – Varma, A.O., Bugatch, E., & German, F.M., Surg. Gynecol. Obstet.

136:281, 1973. 14 – Barrett, D., Jr., & Klibanski, A., Am. J.

Nurs. 73:849, 1973. 15 – Bardfeld, L.A., J.

Pod. Ed. 1:41, 1970.

16 – Blum, G., Schweiz, Rundschau Med Praxis. 62:820, 1973. Abstr. in Dermatology Digest, Feb.

1974, p. 36. 17 – Zaruba, F., Lettl, A., Brozkova, L., Skrdlantova, H., & Krs, V., J.

Hyg. Epidemiol. Microbiol.

Immunol. 18:499, 1974. 18 – Altman, M.I., Goldstein, L., & Horwitz, S., J.

Am. Pod. Assoc.

68:11, 1978. 19 – Rehn, V.J., Med. Klin.

58:799, 1963. 20 – Krauss, H., Koslowski, L., & Zimmermann, W. E., Langenbecks Arch.

Klin. Chir. 303:23, 1963.

21 – Gruenagel, H.H., Med. Klin. 58:442, 1963.

Manufactured by: SMITH & NEPHEW, INC Fort Worth, Texas 76109 US Gov’t License #2004 Marketed by: Smith & Nephew ◊ 1-800-441-8227 Smith & Nephew, Inc., Fort Worth, Texas 76109 © 2016 Smith & Nephew, Inc. SANTYL is a registered trademark of Smith & Nephew, Inc. 140749-0316

📋 Description 45 words ▾

DESCRIPTION Collagenase Santyl ◊ Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum . It possesses the unique ability to digest collagen in necrotic tissue.

⚠️ Precautions 185 words ▾

PRECAUTIONS The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics.

When it is suspected such materials have been used, the site should be carefully cleansed by repeated washings with normal saline before Collagenase Santyl ◊ Ointment is applied. Soaks containing metal ions or acidic solutions should be avoided because of the metal ion and low pH. Cleansing materials such as Dakin’s solution and normal saline are compatible with Collagenase Santyl ◊ Ointment.

Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when Collagenase Santyl ◊ Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound.

Safety and effectiveness in pediatric patients have not been established.

📄 Package Label / Principal Display Panel 10 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2228603f-figure-01

TUBE LABEL.PRINCIPAL DISPLAY PANEL 2228603f-figure-02

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for COLLAGENASE SANTYL — the ingredient across all brands.

Top reported reactions

Death341
Wound Complication159
Application Site Pain109
Pain62
Impaired Healing60
Wound55
Acute Kidney Injury52

Reporter sex

1,617 reports
Male · 45%
Female · 53%
Unknown · 2%

Serious outcomes

Life-threatening23
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 227 77
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by SMITH & NEPHEW, INC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (50484-0010-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
SMITH & NEPHEW, INC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50474-0992-80 · UCB, 50488-0901-01 · Alexso, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.