Sodium Sulfacetamide, Sulfur

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: Sodium Sulfacetamide, Sulfur
Generic name: SULFACETAMIDE SODIUM
Manufacturer: BioComp Pharma, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ed616ece-09b5-41d5-ae58-8e016da2c6b3
SPL ID: 462a018f-3144-d7e4-e063-6394a90ae008
Version: 5
Effective date: 2025-12-17
Source export date: 2026-10-30
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/a3e33fe073aa0aa94eb690c6684c74434c63cebfbf7c5530205a2c3e957ecb8b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:41:15

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Sodium Sulfacetamide, Sulfur	openfda.brand_name
generic name		SULFACETAMIDE SODIUM	openfda.generic_name
manufacturer name		BioComp Pharma, Inc.	openfda.manufacturer_name
ndc	package	44523-542-02	openfda.package_ndc
ndc	product	44523-542	openfda.product_ndc
ndc11	package	44523054202	derived:openfda.package_ndc
rxcui		1005834	openfda.rxcui
spl id		462a018f-3144-d7e4-e063-6394a90ae008	id
spl set id		ed616ece-09b5-41d5-ae58-8e016da2c6b3	set_id
unii		4NRT660KJQ	openfda.unii
unii		70FD1KFU70	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.

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: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).

Reported adverse events (FAERS/openFDA)#

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