FDA.reportPublic FDA data

SULFACETAMIDE SODIUM, SULFUR

Product NDC
81542-202
11-digit product format
815420202
Labeler code
81542
Product ID
81542-202_36c18a52-2828-aaa0-e063-6294a90a6ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Bantry Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-02-08
Substance
SULFUR; SULFACETAMIDE SODIUM
Active strength
50; 100 mg/mL; mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
SULFACETAMIDE SODIUM, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR50 mg/mL
SULFACETAMIDE SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup
4NRT660KJQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
999613Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f433db67-d8a6-320e-e053-2995a90aab52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81542-202-12SULFACETAMIDE SODIUM, SULFUR355 mL in 1 BOTTLESOLUTION3553

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81542-202-12ML - Milliliter81542-202d3733010-529b-43f6-8a2f-48ce8a9a265412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81542-202SULFACETAMIDE SODIUM, SULFUR SOLUTION [BANTRY PHARMA, LLC]2Current NDC, 1 package rows20230907_f433db67-d8a6-320e-e053-2995a90aab52.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURBantry Pharma, LLCf433db67-d8a6-320e-e053-2995a90aab522025-06-04Warnings, Adverse reactionsExact identifier
ndc (product): 81542-202

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNf433db67-d8a6-320e-e053-2995a90aab523
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDf433db67-d8a6-320e-e053-2995a90aab523
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYf433db67-d8a6-320e-e053-2995a90aab523
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYf433db67-d8a6-320e-e053-2995a90aab523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81542-202-1281542020212355 mL in 1 BOTTLE (81542-202-12) 355 ml2023-02-08NoNoCurrent