FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
52187-536
11-digit product format
521870536
Labeler code
52187
Product ID
52187-536_ba0fc821-1fc3-20f9-e053-2a95a90ad977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE, SULFUR
Dosage form
RINSE
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-01-29
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
SODIUM SULFACETAMIDE, 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
ba0fc821-1fc2-20f9-e053-2a95a90ad977Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
52187-536-06SODIUM SULFACETAMIDE, SULFUR170.3 g in 1 BOTTLERINSE170.31
52187-536-12SODIUM SULFACETAMIDE, SULFUR340.2 g in 1 BOTTLERINSE340.21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-536-06GM - Gram52187-536c05c93b1-dd51-4d6c-a5d8-bf7dcfa1472f12021-03-02
52187-536-12GM - Gram52187-5362c6d80aa-5155-4b9f-9748-dc4d51a79b6812021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-536SODIUM SULFACETAMIDE, SULFUR RINSE [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 2 package rows20210131_ba0fc821-1fc2-20f9-e053-2a95a90ad977.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, SULFURSODIUM SULFACETAMIDE, SULFURKMM Pharmaceuticals, LLCba0fc821-1fc2-20f9-e053-2a95a90ad9772021-01-29Warnings, Adverse reactionsExact identifier
ndc (product): 52187-536

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYba0fc821-1fc2-20f9-e053-2a95a90ad9771
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYba0fc821-1fc2-20f9-e053-2a95a90ad9771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-536-0652187053606170.3 g in 1 BOTTLE (52187-536-06) 170.3 g2021-01-290000-00-00NoNoCurrent
52187-536-1252187053612340.2 g in 1 BOTTLE (52187-536-12) 340.2 g2021-01-290000-00-00NoNoCurrent