Plexion
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
- Brand name
- Plexion
- Generic name
- SULFACETAMIDE SODIUM, SULFUR
- Manufacturer
- Eckson Labs, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- d91769aa-ca46-567f-e053-2a95a90a664b
- SPL ID
- d91769aa-ca47-567f-e053-2a95a90a664b
- Version
- 1
- Effective date
- 2022-02-28
- Source export date
- 2026-10-27
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 19:48:53
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | Plexion | openfda.brand_name | |
| generic name | SULFACETAMIDE SODIUM, SULFUR | openfda.generic_name | |
| manufacturer name | Eckson Labs, LLC | openfda.manufacturer_name | |
| ndc | package | 44118-700-10 | openfda.package_ndc |
| ndc | product | 44118-700 | openfda.product_ndc |
| ndc11 | package | 44118070010 | derived:openfda.package_ndc |
| rxcui | 1494169 | openfda.rxcui | |
| rxcui | 1494825 | openfda.rxcui | |
| spl id | d91769aa-ca47-567f-e053-2a95a90a664b | id | |
| spl set id | d91769aa-ca46-567f-e053-2a95a90a664b | set_id | |
| unii | 4NRT660KJQ | openfda.unii | |
| unii | 70FD1KFU70 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.