Sumadan

Product NDC
43538-191
11-digit product format
435380191
Labeler code
43538
Product ID
43538-191_58e4c9c7-d675-4334-a42d-e5d36e9da100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium and sulfur
Dosage form
KIT
Labeler
Medimetriks Pharmaceuticals Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-08-01
Marketing end
0000-00-00
Active strength
0
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43538-191DDiscontinued by firm2026-10-12
excluded packagepackage43538-19143538-191-16DDiscontinued by firm2026-10-12

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 · 30 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 packagepackage43538-191-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43538-191-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43538-191-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43538-191-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43538-191-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43538-191-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43538-191-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43538-191-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43538-191-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43538-191-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43538-191-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43538-191-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43538-191-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43538-191-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43538-191-161332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-191-16EA - Each43538-191f4881768-a6c5-43b6-967b-7f8176f4ec5812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
sulfurACTIVE INGREDIENT70FD1KFU70SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
sulfacetamideACTIVE MOIETY4965G3J0F5SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
SulfurACTIVE MOIETY70FD1KFU70SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
caprylyl glycolINACTIVE INGREDIENT00YIU5438USUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
cholesterolINACTIVE INGREDIENT97C5T2UQ7JSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
disodium oleamido mipa-sulfosuccinateINACTIVE INGREDIENT0MBZ20845FSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
edetate disodiumINACTIVE INGREDIENT7FLD91C86KSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
lemon oilINACTIVE INGREDIENTI9GRO824LLSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
magnesium chlorideINACTIVE INGREDIENT02F3473H9OSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
magnesium nitrateINACTIVE INGREDIENT77CBG3UN78SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFASUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
niacinamideINACTIVE INGREDIENT25X51I8RD4SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
nonoxynol-20INACTIVE INGREDIENT60ZT1XYO5NSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
octoxynol-5INACTIVE INGREDIENTTJ327E1R1VSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
sodium methyl cocoyl taurateINACTIVE INGREDIENTJVL98CG53GSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
sodium thiosulfateINACTIVE INGREDIENTHX1032V43MSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
waterINACTIVE INGREDIENT059QF0KO0RSUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4
xanthan gumINACTIVE INGREDIENTTTV12P4NEESUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-191SUMADAN WASH (SULFACETAMIDE SODIUM AND SULFUR) CREAM SUMADAN (SULFACETAMIDE SODIUM AND SULFUR) KIT [MEDIMETRIKS PHARMACEUTICALS INC.]6Legacy NDC20210124_bd6d3adc-0852-4425-aabb-b8bb62f4a34f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-191-16435380191161 KIT in 1 CARTON (43538-191-16) * 1 BOTTLE, PUMP in 1 CARTON > 454 g in 1 BOTTLE, PUMP * 1 BOTTLE, PUMP in 1 CARTON > 454 g in 1 BOTTLE, PUMP1 kit2011-08-010000-00-00NoNoCurrent