COLLAGENASE SANTYL

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: COLLAGENASE SANTYL
Generic name: COLLAGENASE SANTYL
Manufacturer: SMITH & NEPHEW, INC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd
SPL ID: 155959d1-0367-4fb6-8877-29099d08801c
Version: 3
Effective date: 2019-05-17
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:30:53

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	BLA	101995	derived:openfda.application_number
application number		BLA101995	openfda.application_number
brand name		COLLAGENASE SANTYL	openfda.brand_name
generic name		COLLAGENASE SANTYL	openfda.generic_name
manufacturer name		SMITH & NEPHEW, INC	openfda.manufacturer_name
ndc	package	50484-010-30	openfda.package_ndc
ndc	package	50484-010-90	openfda.package_ndc
ndc	product	50484-010	openfda.product_ndc
ndc11	package	50484001090	derived:openfda.package_ndc
ndc11	package	50484001030	derived:openfda.package_ndc
rxcui		309509	openfda.rxcui
spl id		155959d1-0367-4fb6-8877-29099d08801c	id
spl set id		6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd	set_id
unii		9X7O8V25IT	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.