FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
87026-203
11-digit product format
870260203
Labeler code
87026
Product ID
87026-203_4ba947e2-c5dc-e7f7-e063-6294a90aea33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide 8% Sulfur 4%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Aspen Medical LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-02-01
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
80; 40 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 8% SULFUR 4%Aspen Medical LLC4ba94e96-b107-77fe-e063-6394a90aa9802026-02-21Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFACETAMIDE, SULFUR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM80 mg/g
SULFUR40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1010234

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
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
87026-203-16SODIUM SULFACETAMIDE, SULFUR473 g in 1 BOTTLELIQUID4731

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSN4ba94e96-b107-77fe-e063-6394a90aa9801
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCD4ba94e96-b107-77fe-e063-6394a90aa9801
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSY4ba94e96-b107-77fe-e063-6394a90aa9801
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSY4ba94e96-b107-77fe-e063-6394a90aa9801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87026-203-1687026020316473 g in 1 BOTTLE (87026-203-16) 473 g2026-02-01NoNoCurrent