Ovace Plus

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 Plus
Generic name: SULFACETAMIDE SODIUM
Manufacturer: Mission Pharmacal Company
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 073a44cd-f679-48bd-b90d-cf06f32ff07d
SPL ID: 3c471b79-c192-f4cd-e063-6394a90a631f
Version: 10
Effective date: 2025-08-13
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:10:20

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 Plus	openfda.brand_name
generic name		SULFACETAMIDE SODIUM	openfda.generic_name
manufacturer name		Mission Pharmacal Company	openfda.manufacturer_name
ndc	package	0178-0620-02	openfda.package_ndc
ndc	package	0178-0620-94	openfda.package_ndc
ndc	package	0178-0620-04	openfda.package_ndc
ndc	product	0178-0620	openfda.product_ndc
ndc11	package	00178062002	derived:openfda.package_ndc
ndc11	package	00178062004	derived:openfda.package_ndc
ndc11	package	00178062094	derived:openfda.package_ndc
rxcui		1542380	openfda.rxcui
rxcui		1542377	openfda.rxcui
spl id		3c471b79-c192-f4cd-e063-6394a90a631f	id
spl set id		073a44cd-f679-48bd-b90d-cf06f32ff07d	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.