Sodium Sulfacetamide 9% - Sulfur 4%

Product NDC
71399-0482
11-digit product format
713990482
Labeler code
71399
Product ID
71399-0482_869f17c5-f005-4d57-b97e-f98584ee34b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Akron Pharma Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
90; 40 mg/mL; mg/mL
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%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM90 mg/mL
SULFUR40 mg/mL

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
1001714Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
173fd4d6-1efb-46e3-bf8e-565a265b6d6eAvailable 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
71399-0482-6Sodium Sulfacetamide 9% - Sulfur 4%473 mL in 1 BOTTLE, PLASTICSUSPENSION4734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0482-6ML - Milliliter71399-0482cff9345a-56aa-4f49-a46c-d805cfd1a87512021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0482SODIUM SULFACETAMIDE 9% - SULFUR 4% (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [AKRON PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20240926_173fd4d6-1efb-46e3-bf8e-565a265b6d6e.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 9% - Sulfur 4%SULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.173fd4d6-1efb-46e3-bf8e-565a265b6d6e2024-09-24Warnings, Adverse reactionsExact identifier
ndc (product): 71399-0482

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001714sulfacetamide sodium 9 % / sulfur 4 % Medicated Liquid SoapPSN173fd4d6-1efb-46e3-bf8e-565a265b6d6e4
1001714sulfacetamide sodium 90 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCD173fd4d6-1efb-46e3-bf8e-565a265b6d6e4
1001714sulfacetamide sodium 9 % / sulfur 4 % Medicated Liquid SoapSY173fd4d6-1efb-46e3-bf8e-565a265b6d6e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0482-671399048206473 mL in 1 BOTTLE, PLASTIC (71399-0482-6) 473 ml2024-09-130000-00-00NoNoCurrent