Plexion

Product NDC
57883-405
11-digit product format
578830405
Labeler code
57883
Product ID
57883-405_b711a123-f71e-3c0e-e053-2995a90ae87f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
LOTION
Route
TOPICAL
Labeler
Brava Pharmaceuticals, 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
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57883-405DDiscontinued by firm2026-10-05
excluded packagepackage57883-40557883-405-02DDiscontinued by firm2026-10-05
excluded packagepackage57883-40557883-405-04DDiscontinued by firm2026-10-05

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57883-405-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57883-405-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57883-405-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57883-405-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57883-405-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57883-405-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57883-405-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57883-405-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57883-405-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57883-405-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57883-405-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57883-405-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57883-405-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57883-405-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57883-405-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57883-405-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57883-405-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57883-405-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57883-405-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57883-405-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57883-405-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57883-405-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57883-405-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57883-405-02557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57883-405-02GM - Gram57883-405e8b86183-2b5f-4c0d-9136-050e8437f45012014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5PLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPLEXION (SULFACETAMIDE SODIUM, SULFUR) LOTION [BRAVA PHARMACEUTICALS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57883-405-025788304050257 g in 1 BOTTLE, PLASTIC (57883-405-02) 57 g2005-09-010000-00-00NoNoCurrent
57883-405-045788304050410 TUBE in 1 CARTON (57883-405-04) > 4 g in 1 TUBE10 tube2005-09-010000-00-00NoNoCurrent