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: Laser Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: bdc2211e-6d20-1500-e053-2a95a90ab145
SPL ID: 33de40bd-2015-90b6-e063-6294a90a2617
Version: 4
Effective date: 2025-04-23
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 07:24:40

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 · 12 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		Laser Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	16477-410-12	openfda.package_ndc
ndc	package	16477-410-06	openfda.package_ndc
ndc	product	16477-410	openfda.product_ndc
ndc11	package	16477041012	derived:openfda.package_ndc
ndc11	package	16477041006	derived:openfda.package_ndc
rxcui		1006107	openfda.rxcui
spl id		33de40bd-2015-90b6-e063-6294a90a2617	id
spl set id		bdc2211e-6d20-1500-e053-2a95a90ab145	set_id
unii		4NRT660KJQ	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 THIS AND ALL MEDICATION 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

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.