FDA.reportPublic FDA data

Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser

Product NDC
50405-850
11-digit product format
504050850
Labeler code
50405
Product ID
50405-850_33c53704-fdee-4209-ac08-24ab0e8ebfd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide and Sulfur
Dosage form
LIQUID
Route
TOPICAL
Labeler
SOHM, Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-04-30
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
70FD1KFU70Internal 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
dc4f3e25-a39d-4965-80e8-4fe2361a67d0Available on FDA.report

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
50405-850-01Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser170 g in 1 BOTTLELIQUID1701
50405-850-02Sodium Sulfacetamide 10 % and Sulfur 5 % Cleanser340 g in 1 BOTTLELIQUID3401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50405-850SODIUM SULFACETAMIDE 10 % AND SULFUR 5 % CLEANSER (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [SOHM, INC]1Current NDC, 2 package rows20230504_dc4f3e25-a39d-4965-80e8-4fe2361a67d0.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
Sodium Sulfacetamide 10 % and Sulfur 5 % CleanserSODIUM SULFACETAMIDE AND SULFURSOHM, Incdc4f3e25-a39d-4965-80e8-4fe2361a67d02023-04-30Warnings, Adverse reactionsExact identifier
ndc (product): 50405-850

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYdc4f3e25-a39d-4965-80e8-4fe2361a67d01
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYdc4f3e25-a39d-4965-80e8-4fe2361a67d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50405-850-0150405085001170 g in 1 BOTTLE (50405-850-01) 170 g2023-04-30NoNoCurrent
50405-850-0250405085002340 g in 1 BOTTLE (50405-850-02) 340 g2023-04-30NoNoCurrent