FDA.reportPublic FDA data

SODIUM SULFACETAMIDE

Product NDC
71399-1599
11-digit product format
713991599
Labeler code
71399
Product ID
71399-1599_777ad78c-cd6a-47c1-970d-fbf00d53e09f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE
Dosage form
SHAMPOO
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
832864Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
732dc306-069f-4cbf-9398-8a057829b83eAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-1599-82023-03-26C16284748780-1f386c64a-0f7c-0266-e053-dadaa90a7c1aSODIUM SULFACETAMIDE 10% SHAMPOO Rx Only Fragrance Free FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
71399-1599-82023-01-30C16284748780-1f386c64a-0f7c-0266-e053-dadaa90a7c1aSODIUM SULFACETAMIDE 10% SHAMPOO Rx Only Fragrance Free FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-1599-8SODIUM SULFACETAMIDE237 mL in 1 BOTTLESHAMPOO2373

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1599-8ML - Milliliter71399-159968e270d7-83ab-49dd-82a2-62343d62058912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1599SODIUM SULFACETAMIDE SHAMPOO [AKRON PHARMA INC]3Current NDC, Legacy NDC, 1 package rows20240925_732dc306-069f-4cbf-9398-8a057829b83e.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 Inc732dc306-069f-4cbf-9398-8a057829b83e2024-09-23Warnings, Adverse reactionsExact identifier
ndc (product): 71399-1599

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
832864sulfacetamide sodium 10 % Medicated ShampooPSN732dc306-069f-4cbf-9398-8a057829b83e3
832864sulfacetamide sodium 100 MG/ML Medicated ShampooSCD732dc306-069f-4cbf-9398-8a057829b83e3
832864sulfacetamide sodium 10 % Medicated ShampooSY732dc306-069f-4cbf-9398-8a057829b83e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-1599-871399159908237 mL in 1 BOTTLE (71399-1599-8) 237 ml2024-09-130000-00-00NoNoCurrent