Home NDC 50096-505 Sodium Sulfacetamide 9.8% and Sulfur 4.8%
Product NDC 50096-505
11-digit product format 500960505
Labeler code 50096
Product ID 50096-505_d3ace6da-8695-db5d-e053-2995a90a8f09
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFACETAMIDE SODIUM, SULFUR
Dosage form LOTION
Route TOPICAL
Labeler Rosemar Labs, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2005-09-01
Marketing end 0000-00-00
Substance SULFACETAMIDE SODIUM; SULFUR
Active strength 98 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50096-505-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50096-505-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50096-505-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50096-505-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50096-505-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50096-505-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50096-505-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50096-505-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50096-505-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50096-505-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50096-505-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50096-505-02 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFACETAMIDE SODIUM ACTIVE INGREDIENT 4NRT660KJQ SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 SULFUR ACTIVE INGREDIENT 70FD1KFU70 SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 SULFACETAMIDE ACTIVE MOIETY 4965G3J0F5 SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 SULFUR ACTIVE MOIETY 70FD1KFU70 SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 MAGNESIUM ALUMINUM SILICATE INACTIVE INGREDIENT 6M3P64V0NC SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 PEG-150 DISTEARATE INACTIVE INGREDIENT 6F36Q0I0AC SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 SODIUM THIOSULFATE INACTIVE INGREDIENT HX1032V43M SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SODIUM SULFACETAMIDE 9.8% AND SULFUR 4.8% (SULFACETAMIDE SODIUM, SULFUR) LOTION [ROSEMAR LABS, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50096-505-02 50096050502 57 g in 1 BOTTLE, PLASTIC (50096-505-02) 57 g 2005-09-01 0000-00-00 No No Current