SULFACETAMIDE SODIUM, SULFUR

Product NDC
44523-560
11-digit product format
445230560
Labeler code
44523
Product ID
44523-560_45b4c03d-8b8d-8b9e-e063-6294a90a1699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
EMULSION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 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
SULFACETAMIDE SODIUM, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 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
999613Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ea3cd84-de0f-4981-a420-1d01d1ecd620Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44523-560-06SULFACETAMIDE SODIUM, SULFUR170 g in 1 BOTTLE, PLASTICEMULSION1707
44523-560-08SULFACETAMIDE SODIUM, SULFUR227 g in 1 BOTTLE, PLASTICEMULSION2277
44523-560-12SULFACETAMIDE SODIUM, SULFUR340 g in 1 BOTTLE, PLASTICEMULSION3407

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-560-06GM - Gram44523-560ceb17c39-cf6e-40fb-ad06-903e1b66c91c12023-12-05
44523-560-08GM - Gram44523-56093e713f5-82f3-4784-a0a7-0871ee0697ee12013-12-02
44523-560-12GM - Gram44523-560115818d8-c16b-4985-b3ad-ae3e95c6b2be12023-12-05

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-560SULFACETAMIDE SODIUM, SULFUR EMULSION [BIOCOMP PHARMA, INC.]6Current NDC, Legacy NDC, 3 package rows20231108_0ea3cd84-de0f-4981-a420-1d01d1ecd620.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
SULFACETAMIDE SODIUM, SULFURSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.0ea3cd84-de0f-4981-a420-1d01d1ecd6202025-12-11Warnings, Adverse reactionsExact identifier
ndc (product): 44523-560

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY0ea3cd84-de0f-4981-a420-1d01d1ecd6207
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY0ea3cd84-de0f-4981-a420-1d01d1ecd6207

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-560-0644523056006170 g in 1 BOTTLE, PLASTIC (44523-560-06) 170 g2011-09-15NoNoCurrent
44523-560-0844523056008227 g in 1 BOTTLE, PLASTIC (44523-560-08) 227 g2011-09-150000-00-00NoNoCurrent
44523-560-1244523056012340 g in 1 BOTTLE, PLASTIC (44523-560-12) 340 g2011-09-15NoNoCurrent