FDA.reportPublic FDA data

SODIUM SULFACETAMIDE AND SULFUR

Product NDC
44523-600
11-digit product format
445230600
Labeler code
44523
Product ID
44523-600_2c6307dd-ff18-0654-e063-6294a90afc15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-01-23
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 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 AND SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1494174

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
44523-600-02SODIUM SULFACETAMIDE AND SULFUR57 g in 1 BOTTLE, PLASTICLOTION571
44523-600-02SODIUM SULFACETAMIDE AND SULFUR1 in 1 CARTONLOTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-600-02GM - Gram44523-6003ee74ae3-3527-47ed-81d2-f875934816ca12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-600SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LOTION [BIOCOMP PHARMA, INC.]1Current NDC, 2 package rows20250125_2c631307-b8a3-2978-e063-6394a90a79c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionPSN2c631307-b8a3-2978-e063-6394a90a79c31
1494174sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Topical LotionSCD2c631307-b8a3-2978-e063-6394a90a79c31
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionSY2c631307-b8a3-2978-e063-6394a90a79c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
44523-600-02445230600021 BOTTLE, PLASTIC in 1 CARTON (44523-600-02) / 57 g in 1 BOTTLE, PLASTIC2025-01-23NoNoCurrent