FDA.reportPublic FDA data

Sodium Sulfacetamide 10% and Sulfur 2% Cleanser

Product NDC
71399-0485
11-digit product format
713990485
Labeler code
71399
Product ID
71399-0485_c916e6d5-1e44-4619-b054-926ca7584056
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Akron Pharma Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 20 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 2% Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1000895

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-0485-82023-03-26C16284748780-1f386c64a-1159-0266-e053-dadaa90a7c1aSodium Sulfacetamide 10% - Sulfur 2% Cleanser
71399-0485-82023-01-30C16284748780-1f386c64a-1159-0266-e053-dadaa90a7c1aSodium Sulfacetamide 10% - Sulfur 2% Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0485-8Sodium Sulfacetamide 10% and Sulfur 2% Cleanser227 g in 1 BOTTLE, PLASTICLIQUID2273

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0485-8GM - Gram71399-048579ae87b9-57b2-4362-a5f7-827ced11192d12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0485SODIUM SULFACETAMIDE 10% AND SULFUR 2% CLEANSER (SULFACETAMIDE SODIUM, SULFUR) LIQUID [AKRON PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20240926_2e58df3f-b59d-4333-b9f6-86598e848e9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapPSN2e58df3f-b59d-4333-b9f6-86598e848e9f3
1000895sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Medicated Liquid SoapSCD2e58df3f-b59d-4333-b9f6-86598e848e9f3
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapSY2e58df3f-b59d-4333-b9f6-86598e848e9f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0485-871399048508227 g in 1 BOTTLE, PLASTIC (71399-0485-8) 227 g2024-09-130000-00-00NoNoCurrent