Home NDC 42546-175-16 SulfaCleanse 8/4
Product NDC 42546-175
Requested package NDC 42546-175-16
11-digit product format 425460175
Labeler code 42546
Product ID 42546-175_14b573d4-1fde-4af2-9bba-2901e7326b6b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium sulfacetamide and sulfur
Dosage form LOTION
Route TOPICAL
Labeler PruGen, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2011-05-01
Marketing end 0000-00-00
Substance SULFACETAMIDE SODIUM; SULFUR
Active strength 80 mg/mL; mg/mL
Pharmacologic classes Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42546-175-16 SulfaCleanse 8/4 1 in 1 BOX LOTION 1 3 42546-175-16 SulfaCleanse 8/4 473 mL in 1 BOTTLE, PUMP LOTION 473 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 Aloe INACTIVE INGREDIENT V5VD430YW9 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 Cetyl alcohol INACTIVE INGREDIENT 936JST6JCN SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 Disodium oleamido MEA-sulfosuccinate INACTIVE INGREDIENT 5M1101WGSY SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 Green tea leaf INACTIVE INGREDIENT W2ZU1RY8B0 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 SODIUM COCOYL ISETHIONATE INACTIVE INGREDIENT 518XTE8493 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 TAURINE INACTIVE INGREDIENT 1EQV5MLY3D SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42546-175 SULFACLEANSE 8/4 (SODIUM SULFACETAMIDE AND SULFUR) LOTION [PRUGEN, INC.] 3 Legacy NDC, 2 package rows 20220121_5b7a89e9-1a14-4a43-974e-629883e12db8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42546-175-16 42546017516 1 BOTTLE, PUMP in 1 BOX (42546-175-16) > 473 mL in 1 BOTTLE, PUMP 2011-05-01 0000-00-00 No No Current