Psoriasin Gel

Product NDC: 52389-166
11-digit product format: 523890166
Labeler code: 52389
Product ID: 52389-166_ebf1fc75-1cd9-92fa-e053-2995a90a98ab
Type: HUMAN OTC DRUG
Nonproprietary name: Coal Tar Topical Gel
Dosage form: GEL
Route: TOPICAL
Labeler: Alva-Amco Pharmacal Companies, Inc.
Application: M032
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 1996-02-18
Marketing end: 0000-00-00
Substance: COAL TAR
Active strength: 13 mg/g
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52389-166		D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-01	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-21	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-42	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-43	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-56	D	Discontinued by firm	2026-10-12
excluded package	package	52389-166	52389-166-57	D	Discontinued by firm	2026-10-12

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 · 27 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	52389-166-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-166-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	52389-166-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-166-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	52389-166-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-166-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	52389-166-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-166-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	52389-166-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-166-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	52389-166-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-166-42	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	52389-166-21	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-166-42	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	52389-166-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-166-42	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	52389-166-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-166-42	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	52389-166-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-166-42	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	52389-166-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-166-42	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	52389-166-21	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Coal tar	ACTIVE INGREDIENT	R533ESO2EC	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Coal tar	ACTIVE MOIETY	R533ESO2EC	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
alcohol	INACTIVE INGREDIENT	3K9958V90M	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Aloe vera leaf	INACTIVE INGREDIENT	ZY81Z83H0X	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52389-166	PSORIASIN GEL (COAL TAR TOPICAL GEL) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	13	Legacy NDC	20241106_a046878f-ffc7-417e-9145-5ccc176b4683.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Fungal	ANTI-FUNGAL SHAMPOO	Shenzhen Mengyue Technology Co., Ltd.	482c0243-1073-f578-e063-6294a90adf5c	2026-01-15	Warnings	Exact identifier application number: M032
Kenkoderm Psoriasis Moisturizing	SALICYLIC ACID	Olympus Trading Company, LLC	ca9e4168-dfe9-4fb0-b78d-83b9fe5205f8	2026-01-09	Warnings	Exact identifier application number: M032
Kenkoderm Psoriasis	SALICYLIC ACID	Olympus Trading Company, LLC	9143edff-9809-4620-96fe-6293d5b75df8	2026-01-09	Warnings	Exact identifier application number: M032
DZUL ANTI-DANDRUFF CONDITIONER	PYRITHIONE ZINC	Caball Sales, Inc.	05f29038-f14f-4285-e063-6294a90ac980	2026-01-08	Warnings	Exact identifier application number: M032
DZUL ANTI-DANDRUFF	ZINC PYRITHIONE	Caball Sales, Inc.	05e3fac4-c0ce-cbb9-e063-6294a90ac036	2026-01-08	Warnings	Exact identifier application number: M032
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus Conditioner	SALICYLIC ACID	Kenvue Brands LLC	44906677-88a2-7c68-e063-6294a90a3017	2026-01-02	Warnings	Exact identifier application number: M032
Max OUT	BENZALKONIUM CHLORIDE	Unico	475903d2-a0b0-5d29-e063-6394a90a528f	2026-01-01	Warnings	Exact identifier application number: M032
Flakes Cedar Mint Anti Dandruff	PYRITHIONE ZINC	Cosco International, Inc.	8575e7a0-4290-40a0-949c-317951b440b8	2026-01-01	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Intensive Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ad7707-9d02-31a6-e053-2a95a90ae7ad	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Clinical Strength Dandruff Defense Intensive Itch Relief	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ada541-f12b-76f2-e053-2a95a90a5286	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Lemon Oil 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	e7903f3d-9c5a-f397-e053-2995a90a7895	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Dry Scalp Care with Almond and Coconut Oil	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	ed0bd699-c243-60f4-e053-2995a90a781f	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Shea Butter	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f80a1580-38ba-3dae-e053-6394a90aff5d	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Ginger 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f80a83cc-1174-3ec3-e053-6394a90ab012	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Shea Butter Hair and Scalp Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f7ff4442-5d3f-034a-e053-6394a90a686d	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Dry Scalp Rescue Kit	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	1a3ac96a-04ec-6865-e063-6394a90a9fb8	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Deep Scalp Hydration Daily	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f80aee91-5643-ebbc-e053-6294a90aa5ab	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Deep Scalp Cleanse Daily	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f81e8a83-db95-8246-e053-6294a90a40a4	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Deep Scalp Cleanse 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f81eb5d0-e392-0152-e053-6294a90a2907	2025-12-31	Warnings	Exact identifier application number: M032
Head and Shoulders Deep Scalp Hydration 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	f80e8a60-2b0f-dce2-e053-6394a90ab275	2025-12-31	Warnings	Exact identifier application number: M032

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R533ESO2EC	COAL TAR	8007-45-2	COAL TAR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52389-166-01	52389016601	1 TUBE in 1 CARTON (52389-166-01) > 28.35 g in 1 TUBE (52389-166-28)	1 tube	2013-03-15	0000-00-00	No	No	Current
52389-166-43	52389016643	2 TUBE in 1 BOX (52389-166-43) > 21.25 g in 1 TUBE	2 tube	2020-06-01	0000-00-00	No	No	Current
52389-166-56	52389016656	2 TUBE in 1 CARTON (52389-166-56) > 28.35 g in 1 TUBE (52389-166-28)	2 tube	2013-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Psoriasin Gel	Kobayashi Healthcare International, Inc. \| Kobayashi America Manufacturing, LLC	2026-06-09	HUMAN OTC DRUG LABEL	15