Sodium Sulfacetamide, Sulfur

Product NDC
44523-550
Requested package NDC
44523-550-08
11-digit product format
445230550
Labeler code
44523
Product ID
44523-550_f798f8d7-639f-2a12-e053-6294a90a00fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
EMULSION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 20 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, Sulfur
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR20 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
1000895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99e52390-478e-49ed-87de-aa794379bfebAvailable 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
44523-550-08Sodium Sulfacetamide, Sulfur227 g in 1 BOTTLE, PLASTICEMULSION2275

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-550-08GM - Gram44523-550aef152df-2fb2-4e70-8f2b-24ded3e2442812013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
ACACIAINACTIVE INGREDIENT5C5403N26OSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
HECTORITEINACTIVE INGREDIENT08X4KI73EZSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-550SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20230825_99e52390-478e-49ed-87de-aa794379bfeb.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, SulfurSULFACETAMIDE SODIUM, SULFURBioComp Pharma, Inc.99e52390-478e-49ed-87de-aa794379bfeb2023-08-24Warnings, Adverse reactionsExact identifier
ndc (package): 44523-550-08
ndc (product): 44523-550
ndc11 (package): 44523055008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapPSN99e52390-478e-49ed-87de-aa794379bfeb5
1000895sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Medicated Liquid SoapSCD99e52390-478e-49ed-87de-aa794379bfeb5
1000895sulfacetamide sodium 10 % / sulfur 2 % Medicated Liquid SoapSY99e52390-478e-49ed-87de-aa794379bfeb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-550-0844523055008227 g in 1 BOTTLE, PLASTIC (44523-550-08) 227 g2011-09-150000-00-00NoNoCurrent