SULFACETAMIDE SODIUM

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: SULFACETAMIDE SODIUM
Generic name: SULFACETAMIDE SODIUM
Manufacturer: BioComp Pharma, Inc.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: f79c8287-a832-4f39-ad4d-3a12d64618ab
SPL ID: 462c8be8-3914-a45d-e063-6394a90ac4c2
Version: 6
Effective date: 2025-12-17
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:08:47

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		SULFACETAMIDE SODIUM	openfda.brand_name
generic name		SULFACETAMIDE SODIUM	openfda.generic_name
manufacturer name		BioComp Pharma, Inc.	openfda.manufacturer_name
ndc	package	44523-568-12	openfda.package_ndc
ndc	product	44523-568	openfda.product_ndc
ndc11	package	44523056812	derived:openfda.package_ndc
rxcui		1006107	openfda.rxcui
spl id		462c8be8-3914-a45d-e063-6394a90ac4c2	id
spl set id		f79c8287-a832-4f39-ad4d-3a12d64618ab	set_id
unii		4NRT660KJQ	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.