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: Acella Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 77671f48-b574-490f-a1c2-b321af8dac52
SPL ID: 5682c997-0a0b-82cd-e063-6394a90a51fa
Version: 5
Effective date: 2026-07-13
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:56:43

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		SODIUM SULFACETAMIDE	openfda.brand_name
generic name		SODIUM SULFACETAMIDE	openfda.generic_name
manufacturer name		Acella Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	42192-129-16	openfda.package_ndc
ndc	product	42192-129	openfda.product_ndc
ndc11	package	42192012916	derived:openfda.package_ndc
rxcui		1006107	openfda.rxcui
spl id		5682c997-0a0b-82cd-e063-6394a90a51fa	id
spl set id		77671f48-b574-490f-a1c2-b321af8dac52	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 hypersensitivie 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.