FDA.reportPublic FDA data

SULFACETAMIDE SODIUM

Product NDC
24470-935
Requested package NDC
24470-935-12
11-digit product format
244700935
Labeler code
24470
Product ID
24470-935_0fa3302e-b2b5-6b9b-e063-6394a90abc2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM
Dosage form
GEL
Route
TOPICAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-23
Substance
SULFACETAMIDE SODIUM
Active strength
100 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 SODIUM100 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
1006107Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0fa3302e-b2b4-6b9b-e063-6394a90abc2cAvailable 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
24470-935-12SULFACETAMIDE SODIUM355 mL in 1 BOTTLE, PLASTICGEL3551

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-935-12ML - Milliliter24470-935f4b1a703-af59-4e9f-922a-1b351bad147b12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-935SULFACETAMIDE SODIUM GEL [CINTEX SERVICES, LLC]1Current NDC, 1 package rows20240124_0fa3302e-b2b4-6b9b-e063-6394a90abc2c.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 SODIUMCintex Services, LLC0fa3302e-b2b4-6b9b-e063-6394a90abc2c2024-01-23Warnings, Adverse reactionsExact identifier
ndc (package): 24470-935-12
ndc (product): 24470-935
ndc11 (package): 24470093512

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSN0fa3302e-b2b4-6b9b-e063-6394a90abc2c1
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCD0fa3302e-b2b4-6b9b-e063-6394a90abc2c1
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSY0fa3302e-b2b4-6b9b-e063-6394a90abc2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24470-935-1224470093512355 mL in 1 BOTTLE, PLASTIC (24470-935-12) 355 ml2024-01-23NoNoCurrent