FDA.reportPublic FDA data

SODIUM SULFACETAMIDE

Product NDC
71399-0480
Requested package NDC
71399-0480-2
11-digit product format
713990480
Labeler code
71399
Product ID
71399-0480_fd982d15-1435-4bbf-a29f-71e8bdd4eb2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Akron Pharma Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
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
SODIUM SULFACETAMIDE
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
ba08bf7c-5fdc-447a-b8de-3f319cee7e4eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-0480-22023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-62023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-82023-03-26SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-22023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-62023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-0480-82023-01-30SODIUM SULFACETAMIDE 10% WASH Rx Only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0480-2SODIUM SULFACETAMIDE360 mL in 1 BOTTLELIQUID3605
71399-0480-6SODIUM SULFACETAMIDE480 mL in 1 BOTTLELIQUID4805
71399-0480-8SODIUM SULFACETAMIDE240 mL in 1 BOTTLELIQUID2405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0480-2ML - Milliliter71399-0480cf4e0f2e-982f-44d6-8c99-7afc82b1e38c12019-10-07
71399-0480-6ML - Milliliter71399-048097d1299c-0b6c-43ff-b946-d3abc957227912019-02-13
71399-0480-8ML - Milliliter71399-04805d9c2b75-4ef7-4440-8fcd-f692b5a6031d12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0480SODIUM SULFACETAMIDE LIQUID [AKRON PHARMA INC]5Current NDC, Legacy NDC, 3 package rows20240926_ba08bf7c-5fdc-447a-b8de-3f319cee7e4e.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 SULFACETAMIDESODIUM SULFACETAMIDEAkron Pharma Incba08bf7c-5fdc-447a-b8de-3f319cee7e4e2024-09-24Warnings, Adverse reactionsExact identifier
ndc (package): 71399-0480-2
ndc (product): 71399-0480
ndc11 (package): 71399048002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNba08bf7c-5fdc-447a-b8de-3f319cee7e4e5
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDba08bf7c-5fdc-447a-b8de-3f319cee7e4e5
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYba08bf7c-5fdc-447a-b8de-3f319cee7e4e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0480-271399048002360 mL in 1 BOTTLE (71399-0480-2) 360 ml2024-09-130000-00-00NoNoCurrent