FDA.reportPublic FDA data

Sodium Sulfacetamide and Sulfur

Product NDC
58657-472
11-digit product format
586570472
Labeler code
58657
Product ID
58657-472_4aad4bb3-b1ea-af60-e063-6394a90aeece
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-15
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 and Sulfur
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
Rxcui999613

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
58657-472-06Sodium Sulfacetamide and Sulfur170 g in 1 BOTTLE, PLASTICLIQUID1707
58657-472-07Sodium Sulfacetamide and Sulfur170.3 g in 1 BOTTLE, PLASTICLIQUID170.37
58657-472-08Sodium Sulfacetamide and Sulfur227 g in 1 BOTTLE, PLASTICLIQUID2277
58657-472-12Sodium Sulfacetamide and Sulfur340 g in 1 BOTTLE, PLASTICLIQUID3407
58657-472-13Sodium Sulfacetamide and Sulfur340.2 g in 1 BOTTLE, PLASTICLIQUID340.27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-472-06GM - Gram58657-47286ede03c-4a3d-474a-9219-0dede91d90a612022-02-07
58657-472-07GM - Gram58657-472866470b9-748f-4a59-9812-ae3ea7257ad812022-02-07
58657-472-08GM - Gram58657-4728f8a7aec-3f6d-474d-bc73-76fc92a3bea212022-02-07
58657-472-12GM - Gram58657-4723370d370-b0c1-441a-ba95-5f20a87ce35312022-02-07
58657-472-13GM - Gram58657-4729604bea5-30f4-4332-9822-3b4037eb0c8912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-472SODIUM SULFACETAMIDE AND SULFUR (SULFACETAMIDE SODIUM, SULFUR) LIQUID [METHOD PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 5 package rows20241126_d35a7764-f3c6-fd1b-e053-2a95a90a8036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN7343904e-9fd0-473b-a8c0-b8fce48eea58103
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD7343904e-9fd0-473b-a8c0-b8fce48eea58103
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY7343904e-9fd0-473b-a8c0-b8fce48eea58103
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY7343904e-9fd0-473b-a8c0-b8fce48eea58103
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNfb17c3be-a752-4591-a9f4-ecf32096d65c101
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDfb17c3be-a752-4591-a9f4-ecf32096d65c101
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYfb17c3be-a752-4591-a9f4-ecf32096d65c101
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYfb17c3be-a752-4591-a9f4-ecf32096d65c101
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN2a8c6cc3-62b6-4682-9670-df9c0e6cb2e1100
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD2a8c6cc3-62b6-4682-9670-df9c0e6cb2e1100
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY2a8c6cc3-62b6-4682-9670-df9c0e6cb2e1100
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY2a8c6cc3-62b6-4682-9670-df9c0e6cb2e1100
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSNd35a7764-f3c6-fd1b-e053-2a95a90a80367
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCDd35a7764-f3c6-fd1b-e053-2a95a90a80367
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSYd35a7764-f3c6-fd1b-e053-2a95a90a80367
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSYd35a7764-f3c6-fd1b-e053-2a95a90a80367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-472-0658657047206170 g in 1 BOTTLE, PLASTIC (58657-472-06) 170 g2021-11-150000-00-00NoNoCurrent
58657-472-0758657047207170.3 g in 1 BOTTLE, PLASTIC (58657-472-07) 170.3 g2021-11-150000-00-00NoNoCurrent
58657-472-0858657047208227 g in 1 BOTTLE, PLASTIC (58657-472-08) 227 g2021-11-150000-00-00NoNoCurrent
58657-472-1258657047212340 g in 1 BOTTLE, PLASTIC (58657-472-12) 340 g2021-11-150000-00-00NoNoCurrent
58657-472-1358657047213340.2 g in 1 BOTTLE, PLASTIC (58657-472-13) 340.2 g2021-11-150000-00-00NoNoCurrent