SODIUM SULFACETAMIDE AND 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 AND SULFUR
Generic name: SULFACETAMIDE SODIUM, SULFUR
Manufacturer: BioComp Pharma, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 1352eff6-8b9e-473d-9acf-c0086e1d0917
SPL ID: 47e8280b-fd31-6274-e063-6394a90ad3b9
Version: 6
Effective date: 2026-01-08
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:39:03

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 AND SULFUR	openfda.brand_name
generic name		SULFACETAMIDE SODIUM, SULFUR	openfda.generic_name
manufacturer name		BioComp Pharma, Inc.	openfda.manufacturer_name
ndc	package	44523-602-01	openfda.package_ndc
ndc	product	44523-602	openfda.product_ndc
ndc11	package	44523060201	derived:openfda.package_ndc
rxcui		1005856	openfda.rxcui
spl id		47e8280b-fd31-6274-e063-6394a90ad3b9	id
spl set id		1352eff6-8b9e-473d-9acf-c0086e1d0917	set_id
unii		4NRT660KJQ	openfda.unii
unii		70FD1KFU70	openfda.unii

Warnings cross-check#

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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#

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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.