PsorMedicor

Product NDC
54095-111
11-digit product format
540950111
Labeler code
54095
Product ID
54095-111_6dd21e95-eb18-4f04-9099-a8fbc9d10b9f
Type
HUMAN OTC DRUG
Nonproprietary name
COAL TAR
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-11
Marketing end
0000-00-00
Substance
COAL TAR
Active strength
3 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct54095-111IInactivated by FDA2026-10-12
excluded packagepackage54095-11154095-111-10IInactivated by FDA2026-10-12

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 · 44 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 packagepackage54095-111-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage54095-111-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage54095-111-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage54095-111-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage54095-111-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage54095-111-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage54095-111-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage54095-111-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54095-111-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage54095-111-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage54095-111-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage54095-111-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage54095-111-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage54095-111-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage54095-111-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage54095-111-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage54095-111-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage54095-111-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage54095-111-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54095-111-10e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54095-111-109bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage54095-111-10110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54095-111-102019-11-27C16284748780-19855e2a2-48bd-60a7-e053-dbdaa90a05bdDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54095-111-10PsorMedicorPremium Skin Care Product50 g in 1 BOTTLE, PLASTICOINTMENT502

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAL TARACTIVE INGREDIENTR533ESO2ECPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
COAL TARACTIVE MOIETYR533ESO2ECPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
1,3-DIMETHYLUREAINACTIVE INGREDIENTWAM6DR9I4XPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
LANOLININACTIVE INGREDIENT7EV65EAW6HPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33APSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
THYMOLINACTIVE INGREDIENT3J50XA376EPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2
WATERINACTIVE INGREDIENT059QF0KO0RPSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54095-111PSORMEDICOR PREMIUM SKIN CARE PRODUCT (COAL TAR) OINTMENT [Z.H.T. ENGINEERING EQUIPMENT AND TECHNOLOGIES LTD]2Legacy NDC, 1 package rows20131112_8a04001f-1e66-43d3-95c0-8adbbb723ea2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358008coal tar 2.5 % Topical OintmentPSN8a04001f-1e66-43d3-95c0-8adbbb723ea22
1358008coal tar 0.025 MG/MG Topical OintmentSCD8a04001f-1e66-43d3-95c0-8adbbb723ea22
1358008coal tar 2.5 % Topical OintmentSY8a04001f-1e66-43d3-95c0-8adbbb723ea22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
54095-111-105409501111050 g in 1 BOTTLE, PLASTIC50 gHistorical