FDA.reportPublic FDA data

SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream

Product NDC
58657-468
11-digit product format
586570468
Labeler code
58657
Product ID
58657-468_4aad5cbd-7439-efb2-e063-6394a90ae98a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-05-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 mg/g; 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 10% AND SULFUR 5% Emollient Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005834

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
58657-468-01SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream28 g in 1 BOTTLE, PLASTICCREAM289
58657-468-02SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient Cream57 g in 1 BOTTLE, PLASTICCREAM579

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-468-01GM - Gram58657-4682c524619-dcc0-4b31-9a5b-dea2a67560fa12022-07-06
58657-468-02GM - Gram58657-46859ff58d5-7fa1-4728-ad50-0a6b8a4a698612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-468SODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAM CREAM [METHOD PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 2 package rows20241126_dfc5bab2-2170-606e-e053-2a95a90a3961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSN4ebfcaae-a375-45aa-a7f9-2b622f564f02101
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCD4ebfcaae-a375-45aa-a7f9-2b622f564f02101
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSY4ebfcaae-a375-45aa-a7f9-2b622f564f02101
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSNdfc5bab2-2170-606e-e053-2a95a90a39619
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCDdfc5bab2-2170-606e-e053-2a95a90a39619
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSYdfc5bab2-2170-606e-e053-2a95a90a39619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-468-015865704680128 g in 1 BOTTLE, PLASTIC (58657-468-01) 28 g2022-05-150000-00-00NoNoCurrent
58657-468-025865704680257 g in 1 BOTTLE, PLASTIC (58657-468-02) 57 g2022-05-150000-00-00NoNoCurrent