SODIUM SULFACETAMIDE

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
Generic name: SODIUM SULFACETAMIDE
Manufacturer: Akron Pharma Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: ba08bf7c-5fdc-447a-b8de-3f319cee7e4e
SPL ID: fd982d15-1435-4bbf-a29f-71e8bdd4eb2f
Version: 5
Effective date: 2024-09-24
Source export date: 2026-11-06
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/824fe785252d7061429a95ddb6de517ee399ef628d34e8fdcc3591ded286ae33/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:23:57

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
brand name		SODIUM SULFACETAMIDE	openfda.brand_name
generic name		SODIUM SULFACETAMIDE	openfda.generic_name
manufacturer name		Akron Pharma Inc	openfda.manufacturer_name
ndc	package	71399-0480-8	openfda.package_ndc
ndc	package	71399-0480-6	openfda.package_ndc
ndc	package	71399-0480-2	openfda.package_ndc
ndc	product	71399-0480	openfda.product_ndc
ndc11	package	71399048006	derived:openfda.package_ndc
ndc11	package	71399048002	derived:openfda.package_ndc
ndc11	package	71399048008	derived:openfda.package_ndc
rxcui		1006107	openfda.rxcui
spl id		fd982d15-1435-4bbf-a29f-71e8bdd4eb2f	id
spl set id		ba08bf7c-5fdc-447a-b8de-3f319cee7e4e	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#

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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.