DERMAKLEAR AKNE TREATMENT WITH SULFUR

Product NDC
59800-0107
11-digit product format
598000107
Labeler code
59800
Product ID
59800-0107_d824b4ea-c759-494f-ab49-884c14ab7aae
Type
HUMAN OTC DRUG
Nonproprietary name
SULFUR
Dosage form
SOAP
Route
TOPICAL
Labeler
Schwabe North America, Inc
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2004-07-01
Marketing end
2022-12-31
Substance
SULFUR
Active strength
5 g/85g
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct59800-0107DDiscontinued by firm2026-10-15
excluded packagepackage59800-010759800-0107-0DDiscontinued by firm2026-10-15

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 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 packagepackage59800-0107-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59800-0107-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage59800-0107-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage59800-0107-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage59800-0107-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage59800-0107-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage59800-0107-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59800-0107-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59800-0107-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59800-0107-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59800-0107-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59800-0107-0557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFURACTIVE INGREDIENT70FD1KFU70DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SULFURACTIVE MOIETY70FD1KFU70DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
ETIDRONATE TETRASODIUMINACTIVE INGREDIENTCZZ9T1T1X4DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
GLYCYRRHIZININACTIVE INGREDIENT6FO62043WKDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
HAWTHORN LEAF WITH FLOWERINACTIVE INGREDIENT6OM09RPY36DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
PENTASODIUM PENTETATEINACTIVE INGREDIENT961TOZ5L7TDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
POLYGONATUM MULTIFLORUM ROOTINACTIVE INGREDIENTEYW899536CDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
ROSEMARYINACTIVE INGREDIENTIJ67X351P9DERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SAGEINACTIVE INGREDIENT065C5D077JDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SODIUM COCOATEINACTIVE INGREDIENTR1TQH25F4IDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SODIUM PALM KERNELATEINACTIVE INGREDIENT6H91L1NXTWDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
SODIUM PALMATEINACTIVE INGREDIENTS0A6004K3ZDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RDERMAKLEAR AKNE TREATMENT WITH SULFUR (SULFUR) SOAP [ENZYMATIC THERAPY, LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59800-0107-0598000107001 BAG in 1 BOX (59800-0107-0) > 85 g in 1 BAG1 bag2004-07-012022-12-31NoNoCurrent