Denorex Therapeutic

Product NDC
51545-220
Requested package NDC
51545-220-12
11-digit product format
515450220
Labeler code
51545
Product ID
51545-220_c3b7a13f-0be8-8dd4-e053-2a95a90a7987
Type
HUMAN OTC DRUG
Nonproprietary name
Coal Tar and Menthol
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Ultimark Products LLC
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-09-09
Marketing end
0000-00-00
Substance
COAL TAR; MENTHOL
Active strength
0 g/mL; g/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51545-22051545-220-12DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
COAL TARACTIVE INGREDIENTR533ESO2ECDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
MENTHOLACTIVE INGREDIENTL7T10EIP3ADENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
COAL TARACTIVE MOIETYR533ESO2ECDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
MENTHOLACTIVE MOIETYL7T10EIP3ADENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0DENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC1DENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
CHLOROXYLENOLINACTIVE INGREDIENT0F32U78V2QDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
LAURIC DIETHANOLAMIDEINACTIVE INGREDIENTI29I2VHG38DENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATEINACTIVE INGREDIENTV176GWC2SRDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
TRIETHANOLAMINE LAURYL SULFATEINACTIVE INGREDIENTE8458C1KAADENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RDENOREX THERAPEUTIC (COAL TAR AND MENTHOL) SHAMPOO [ULTIMARK PRODUCTS LLC]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51545-220-1251545022012296 mL in 1 BOTTLE (51545-220-12) 296 ml2019-09-090000-00-00NoNoCurrent