FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
52187-531
11-digit product format
521870531
Labeler code
52187
Product ID
52187-531_a6185774-2622-4f52-e053-2995a90a42c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE, SULFUR
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-05-20
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
80; 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, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR80 mg/mL
SULFACETAMIDE SODIUM40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup
4NRT660KJQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010234Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6185774-2621-4f52-e053-2995a90a42c0Available 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
52187-531-16SODIUM SULFACETAMIDE, SULFUR473 mL in 1 BOTTLESUSPENSION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-531-16ML - Milliliter52187-531fd1a0a9e-266b-44d4-829b-fe9f5993a13112020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-531SODIUM SULFACETAMIDE, SULFUR SUSPENSION [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 1 package rows20200521_a6185774-2621-4f52-e053-2995a90a42c0.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, LLCa6185774-2621-4f52-e053-2995a90a42c02020-05-20Warnings, Adverse reactionsExact identifier
ndc (product): 52187-531

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapPSNa6185774-2621-4f52-e053-2995a90a42c01
1010234sulfacetamide sodium 80 MG/ML / sulfur 40 MG/ML Medicated Liquid SoapSCDa6185774-2621-4f52-e053-2995a90a42c01
1010234sulfacetamide sodium 8 % / sulfur 4 % Medicated Liquid SoapSYa6185774-2621-4f52-e053-2995a90a42c01
1010234sulfacetamide sodium 8 % / sulfur 4 % Topical SuspensionSYa6185774-2621-4f52-e053-2995a90a42c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-531-1652187053116473 mL in 1 BOTTLE (52187-531-16) 473 ml2020-05-200000-00-00NoNoCurrent