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 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
1115894Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29c84706-b96b-45e8-b84a-b130a2d1e9b5Available 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
71399-0484-6Sodium 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

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 4.5% WashSULFACETAMIDE SODIUM, SULFURAkron Pharma Inc.29c84706-b96b-45e8-b84a-b130a2d1e9b52024-09-24Warnings, Adverse reactionsExact identifier
ndc (product): 71399-0484

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