FDA.reportPublic FDA data

Sodium Sulfacetamide 9% - Sulfur 4.5% Wash

Product NDC
71399-0484
11-digit product format
713990484
Labeler code
71399
Product ID
71399-0484_02efa27e-6f2e-4c57-84f5-e7750d5b4c08
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
90; 45 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 9% - Sulfur 4.5% Wash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM90 mg/g
SULFUR45 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1115894

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
71399-0484-6Sodium Sulfacetamide 9% - Sulfur 4.5% Wash454 g in 1 BOTTLE, PLASTICLIQUID4544

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0484-6GM - Gram71399-0484d1e5e032-df90-477e-92d5-620321e3468812021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0484SODIUM SULFACETAMIDE 9% - SULFUR 4.5% WASH (SULFACETAMIDE SODIUM, SULFUR) LIQUID [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20240926_29c84706-b96b-45e8-b84a-b130a2d1e9b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115894sulfacetamide sodium 9 % / sulfur 4.5 % Medicated Liquid SoapPSN29c84706-b96b-45e8-b84a-b130a2d1e9b54
1115894sulfacetamide sodium 90 MG/ML / sulfur 45 MG/ML Medicated Liquid SoapSCD29c84706-b96b-45e8-b84a-b130a2d1e9b54
1115894sulfacetamide sodium 9 % / sulfur 4.5 % Medicated Liquid SoapSY29c84706-b96b-45e8-b84a-b130a2d1e9b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0484-671399048406454 g in 1 BOTTLE, PLASTIC (71399-0484-6) 454 g2024-09-130000-00-00NoNoCurrent