FDA.reportPublic FDA data

Sodium Sulfacetamide

Product NDC
58657-477
Requested package NDC
58657-477-12
11-digit product format
586570477
Labeler code
58657
Product ID
58657-477_4aad445c-77e0-b8cd-e063-6394a90afd06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Sulfacetamide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-01-15
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sodium Sulfacetamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g

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
d65e777b-682b-732d-e053-2a95a90a41adAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-477-06Sodium Sulfacetamide177 g in 1 BOTTLELIQUID1777
58657-477-12Sodium Sulfacetamide355 g in 1 BOTTLELIQUID3557
58657-477-16Sodium Sulfacetamide480 g in 1 BOTTLELIQUID4807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-477-06GM - Gram58657-477069c9e74-b394-4c1e-a476-b7b0a436620c12022-04-06
58657-477-12GM - Gram58657-477f583e409-ea67-45c2-a1f4-30e56bf7225912022-04-06
58657-477-16GM - Gram58657-477cb146c33-42ff-4bb0-bd13-123f5d06163212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-477SODIUM SULFACETAMIDE LIQUID [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 3 package rows20241126_d65e777b-682b-732d-e053-2a95a90a41ad.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 SULFACETAMIDEMethod Pharmaceuticals, LLCd65e777b-682b-732d-e053-2a95a90a41ad2026-02-12WarningsExact identifier
ndc (package): 58657-477-12
ndc (product): 58657-477
ndc11 (package): 58657047712

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSN3cc796f7-b1e9-4804-9009-2bf578ba7a53103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNc9f90612-32c6-44ba-85d5-82842f0e1ba9103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNed2ab442-617b-472a-a7a3-f178b5b8c441103
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCD3cc796f7-b1e9-4804-9009-2bf578ba7a53103
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDc9f90612-32c6-44ba-85d5-82842f0e1ba9103
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDed2ab442-617b-472a-a7a3-f178b5b8c441103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSY3cc796f7-b1e9-4804-9009-2bf578ba7a53103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYc9f90612-32c6-44ba-85d5-82842f0e1ba9103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYed2ab442-617b-472a-a7a3-f178b5b8c441103
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNacd3fb4a-558d-4565-84d8-23a0d917eab6100
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDacd3fb4a-558d-4565-84d8-23a0d917eab6100
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYacd3fb4a-558d-4565-84d8-23a0d917eab6100
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNd65e777b-682b-732d-e053-2a95a90a41ad7
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDd65e777b-682b-732d-e053-2a95a90a41ad7
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYd65e777b-682b-732d-e053-2a95a90a41ad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-477-1258657047712355 g in 1 BOTTLE (58657-477-12) 355 g2022-01-150000-00-00NoNoCurrent