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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
999613Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d35a7764-f3c6-fd1b-e053-2a95a90a8036Available 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
58657-472-06Sodium 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

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 Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticals, LLCd35a7764-f3c6-fd1b-e053-2a95a90a80362026-02-12WarningsExact identifier
ndc (product): 58657-472

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