FDA.reportPublic FDA data

SODIUM SULFACETAMIDE and SULFUR

Product NDC
42192-104
11-digit product format
421920104
Labeler code
42192
Product ID
42192-104_0e76cbc6-8cf0-7dc8-e063-6294a90a815a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE and SULFUR
Dosage form
LIQUID
Route
TOPICAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2008-06-04
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 10 mg/g; mg/g
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 and SULFUR
Brand name suffix
Wash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR10 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
999604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8da300bc-834c-4814-a799-b9ebc9056d8dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-104-06SODIUM SULFACETAMIDE and SULFURWash170.1 g in 1 TUBELIQUID170.15
42192-104-06SODIUM SULFACETAMIDE and SULFURWash1 in 1 CARTONLIQUID15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-104-06GM - Gram42192-104158327ea-c753-4193-8cac-38f07c54a8e112013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5USODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-104SODIUM SULFACETAMIDE AND SULFUR WASH (SODIUM SULFACETAMIDE AND SULFUR) LIQUID [ACELLA PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20240110_8da300bc-834c-4814-a799-b9ebc9056d8d.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 SULFUR WashSODIUM SULFACETAMIDE AND SULFURAcella Pharmaceuticals, LLC8da300bc-834c-4814-a799-b9ebc9056d8d2024-01-08Warnings, Adverse reactionsExact identifier
ndc (product): 42192-104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999604sulfacetamide sodium 10 % / sulfur 1 % Medicated Liquid SoapPSN8da300bc-834c-4814-a799-b9ebc9056d8d5
999604sulfacetamide sodium 100 MG/ML / sulfur 10 MG/ML Medicated Liquid SoapSCD8da300bc-834c-4814-a799-b9ebc9056d8d5
999604sulfacetamide sodium 10 % / sulfur 1 % Medicated Liquid SoapSY8da300bc-834c-4814-a799-b9ebc9056d8d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-104-06421920104061 TUBE in 1 CARTON (42192-104-06) / 170.1 g in 1 TUBE1 tube2008-06-040000-00-00NoNoCurrent