FDA.reportPublic FDA data

SULFACETAMIDE SODIUM

Product NDC
52187-553
11-digit product format
521870553
Labeler code
52187
Product ID
52187-553_d7fc8def-53f9-56c1-e053-2995a90a2434
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
KMM Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-10-06
Substance
SULFACETAMIDE SODIUM
Active strength
98 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
SULFACETAMIDE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2571664Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdb5b3dc-9f75-85b7-e053-2a95a90a380cAvailable 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
52187-553-08SULFACETAMIDE SODIUM237 mL in 1 BOTTLESHAMPOO2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52187-553-08ML - Milliliter52187-5532fbe6e60-0b36-4156-802d-5e8ddd690f4e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52187-553SULFACETAMIDE SODIUM SHAMPOO [KMM PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20220215_cdb5b3dc-9f75-85b7-e053-2a95a90a380c.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 SODIUMSULFACETAMIDE SODIUMKMM Pharmaceuticals, LLCcdb5b3dc-9f75-85b7-e053-2a95a90a380c2022-02-14Warnings, Adverse reactionsExact identifier
ndc (product): 52187-553

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2571664sulfacetamide sodium 9.8 % Medicated ShampooPSNcdb5b3dc-9f75-85b7-e053-2a95a90a380c3
2571664sulfacetamide sodium 98 MG/ML Medicated ShampooSCDcdb5b3dc-9f75-85b7-e053-2a95a90a380c3
2571664sulfacetamide sodium 9.8 % Medicated ShampooSYcdb5b3dc-9f75-85b7-e053-2a95a90a380c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52187-553-0852187055308237 mL in 1 BOTTLE (52187-553-08) 237 ml2021-10-060000-00-00NoNoCurrent