FDA.reportPublic FDA data

SULFACETAMIDE SODIUM, SULFUR

Product NDC
52187-548
11-digit product format
521870548
Labeler code
52187
Product ID
52187-548_db841a96-42cc-6ff6-e053-2995a90a7cca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-03-31
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
SULFACETAMIDE SODIUM, SULFUR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 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
1494174Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
db841a96-42cb-6ff6-e053-2995a90a7ccaAvailable 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
52187-548-02SULFACETAMIDE SODIUM, SULFUR57 g in 1 BOTTLE, PLASTICLOTION571

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-548-02GM - Gram52187-5488c8a1852-7ef2-45f3-ab67-882ceed1cb6112022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-548SULFACETAMIDE SODIUM, SULFUR LOTION [KMM PHARMACEUTICALS, LLC]1Current NDC, Legacy NDC, 1 package rows20220402_db841a96-42cb-6ff6-e053-2995a90a7cca.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, SULFURKMM Pharmaceuticals, LLCdb841a96-42cb-6ff6-e053-2995a90a7cca2022-03-31Warnings, Adverse reactionsExact identifier
ndc (product): 52187-548

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionPSNdb841a96-42cb-6ff6-e053-2995a90a7cca1
1494174sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Topical LotionSCDdb841a96-42cb-6ff6-e053-2995a90a7cca1
1494174sulfacetamide sodium 9.8 % / sulfur 4.8 % Topical LotionSYdb841a96-42cb-6ff6-e053-2995a90a7cca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-548-025218705480257 g in 1 BOTTLE, PLASTIC (52187-548-02) 57 g2022-03-310000-00-00NoNoCurrent