OVACE

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: OVACE
Generic name: SULFACETAMIDE SODIUM
Manufacturer: Mission Pharmacal Company
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: a77aed6c-355f-44ed-ae95-78b4d1549c2b
SPL ID: 47e771ab-b852-724f-e063-6394a90ac63c
Version: 10
Effective date: 2026-01-08
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:55:23

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		OVACE	openfda.brand_name
generic name		SULFACETAMIDE SODIUM	openfda.generic_name
manufacturer name		Mission Pharmacal Company	openfda.manufacturer_name
ndc	package	0178-0499-12	openfda.package_ndc
ndc	package	0178-0499-16	openfda.package_ndc
ndc	package	0178-0499-06	openfda.package_ndc
ndc	product	0178-0499	openfda.product_ndc
ndc11	package	00178049912	derived:openfda.package_ndc
ndc11	package	00178049916	derived:openfda.package_ndc
ndc11	package	00178049906	derived:openfda.package_ndc
rxcui		1006110	openfda.rxcui
rxcui		1006107	openfda.rxcui
spl id		47e771ab-b852-724f-e063-6394a90ac63c	id
spl set id		a77aed6c-355f-44ed-ae95-78b4d1549c2b	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.