Home NDC 44523-535-02 Sodium Sulfacetamide, Sulfur
Product NDC 44523-535
Requested package NDC 44523-535-02
11-digit product format 445230535
Labeler code 44523
Product ID 44523-535_b83e4fd0-1054-f845-e053-2a95a90a63d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFACETAMIDE SODIUM, SULFUR
Dosage form CREAM
Route TOPICAL
Labeler BioComp Pharma, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-09-15
Marketing end 0000-00-00
Substance SULFACETAMIDE SODIUM; SULFUR
Active strength 100 mg/g; mg/g
Pharmacologic classes Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 44523-535 44523-535-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 ISOSTEARYL PALMITATE INACTIVE INGREDIENT 9EHU0R7ER1 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 POLYSORBATE 60 INACTIVE INGREDIENT CAL22UVI4M SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 SODIUM LACTATE INACTIVE INGREDIENT TU7HW0W0QT SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1 ZINC OXIDE INACTIVE INGREDIENT SOI2LOH54Z SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-535 SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) CREAM [BIOCOMP PHARMA, INC.] 6 Legacy NDC 20250209_01db0daf-1704-47c9-8845-6d5ec56e33ec.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 44523-535-02 44523053502 57 g in 1 BOTTLE, PLASTIC (44523-535-02) 57 g 2011-09-15 0000-00-00 No No Current