OvacePlus 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: OvacePlus Plus
Generic name: SULFACETAMIDE SODIUM
Manufacturer: Mission Pharmacal Company
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 06876575-edf2-4844-8f20-3eb6e74ccc8e
SPL ID: 3c3321a2-fd6d-24eb-e063-6394a90ab4dd
Version: 9
Effective date: 2025-08-12
Source export date: 2026-10-30
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/2026-10-30/023bc8d8aae5addb7530087bbbdb169b3ccbf36764f15b8ca67db07e1e5aea8b/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:07:57

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		OvacePlus Plus	openfda.brand_name
generic name		SULFACETAMIDE SODIUM	openfda.generic_name
manufacturer name		Mission Pharmacal Company	openfda.manufacturer_name
ndc	package	0178-0495-02	openfda.package_ndc
ndc	package	0178-0495-04	openfda.package_ndc
ndc	product	0178-0495	openfda.product_ndc
ndc11	package	00178049504	derived:openfda.package_ndc
ndc11	package	00178049502	derived:openfda.package_ndc
rxcui		1006683	openfda.rxcui
rxcui		1006684	openfda.rxcui
spl id		3c3321a2-fd6d-24eb-e063-6394a90ab4dd	id
spl set id		06876575-edf2-4844-8f20-3eb6e74ccc8e	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.