FDA.reportPublic FDA data

Sodium Sulfacetamide 10% and Sulfur 5% Cleanser

Product NDC
82429-107
11-digit product format
824290107
Labeler code
82429
Product ID
82429-107_ea57060c-515c-653b-e053-2995a90a63c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Sulfur
Dosage form
RINSE
Route
TOPICAL
Labeler
Gabar Health Sciences Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-10-10
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
10 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82429-107DDiscontinued by firm2026-10-05
excluded packagepackage82429-10782429-107-06DDiscontinued by firm2026-10-05
excluded packagepackage82429-10782429-107-08DDiscontinued by firm2026-10-05
excluded packagepackage82429-10782429-107-12DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82429-107-06GM - Gram82429-107c6695667-94b9-404a-979e-0e25d094eff812023-05-05
82429-107-08GM - Gram82429-10753132e87-8603-4e08-a6f7-ffc82d3e135e12022-11-07
82429-107-12GM - Gram82429-10796f59f8a-59e9-48b9-b6eb-9dfe941cad1b12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82429-107SODIUM SULFACETAMIDE 10% AND SULFUR 5% CLEANSER (SULFACETAMIDE SODIUM AND SULFUR) RINSE [GABAR HEALTH SCIENCES CORP.]4Legacy NDC20231022_b954cee5-d1e6-405e-9946-e7b40aeee389.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82429-107-08824290107081 BOTTLE in 1 CARTON (82429-107-08) > 227 g in 1 BOTTLE1 bottle2022-07-010000-00-00NoNoCurrent