Sodium Sulfacetamide 9 Sulfur 4.5 Wash

Product NDC
54295-301
11-digit product format
542950301
Labeler code
54295
Product ID
54295-301_e3f1f9eb-f82d-4229-b0c0-0147b23a9022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfacetamide Sodium and Sulfur
Dosage form
RINSE
Route
TOPICAL
Labeler
Trinity Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-12-10
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
9 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct54295-301DDiscontinued by firm2026-09-14
excluded packagepackage54295-30154295-301-21DDiscontinued by firm2026-09-14

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage54295-301-21DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54295-301-21DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54295-301-21DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54295-301-21DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54295-301-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54295-301-21DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54295-301-21DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54295-301-21DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54295-301-21DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54295-301-21DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54295-301-21DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54295-301-21DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54295-301-21EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54295-301-21GM - Gram54295-301c0744090-b6e8-4f68-922d-b6c28d28419912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sulfacetamide SodiumACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SulfurACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SulfacetamideACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SulfurACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
DISODIUM OLEAMIDO MEA-SULFOSUCCINATEINACTIVE INGREDIENT5M1101WGSYSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493SODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE 9 SULFUR 4.5 WASH (SULFACETAMIDE SODIUM AND SULFUR) RINSE [TRINITY PHARMACEUTICALS, LLC]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54295-301-21542950301211 BOTTLE in 1 CARTON (54295-301-21) > 454 g in 1 BOTTLE1 bottle2012-12-100000-00-00NoNoCurrent