FDA.reportPublic FDA data

Sodium Sulfacetamide 10 Sulfur 2 Cleanser

Product NDC
82568-0155
11-digit product format
825680155
Labeler code
82568
Product ID
82568-0155_4fae7ae4-278c-39a7-e063-6294a90ad09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Sulfur
Dosage form
SOLUTION
Route
TOPICAL
Labeler
AARNA USA INC.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-30
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82568-0155DDiscontinued by firm2026-08-03
excluded packagepackage82568-015582568-0155-8DDiscontinued by firm2026-08-03

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
82568-0155-8Sodium Sulfacetamide 10 Sulfur 2 Cleanser227 g in 1 BOTTLESOLUTION2272

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0155-8GM - Gram82568-015599460b1b-8c67-4db2-804c-ac8a6864b46312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapPSN4e42de4d-7f6a-a70d-e063-6294a90aa9982
1000895sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Medicated Liquid SoapSCD4e42de4d-7f6a-a70d-e063-6294a90aa9982
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapSY4e42de4d-7f6a-a70d-e063-6294a90aa9982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0155-882568015508227 g in 1 BOTTLE (82568-0155-8) 227 g2026-03-30NoNoHistorical