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	2026-10-05
excluded package	package	52389-166	52389-166-01	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-21	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-42	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-43	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-56	D	Discontinued by firm	2026-10-05
excluded package	package	52389-166	52389-166-57	D	Discontinued by firm	2026-10-05

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 6 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dove	SOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF CONDITIONER	Conopco d/b/a Unilever	4ef55722-df78-0e4c-e063-6294a90a8540	2026-04-08	Warnings	Exact identifier application number: M032
Dove Men Care	FORTIFYING SHAMPOO AND CONDITIONER ANTI-DANDRUFF 2 IN 1 PYRITHIONE ZINC SHAMPOO	Conopco d/b/a Unilever	4ecf22e8-e318-26f7-e063-6294a90a5477	2026-04-07	Warnings	Exact identifier application number: M032
Dove Men Care	ANTI-DANDRUFF 2IN1 SHAMPOO AND CONDITIONER	Conopco d/b/a Unilever	4ecce67b-b2e0-b757-e063-6294a90a224e	2026-04-07	Warnings	Exact identifier application number: M032
Dove Men Care	ANTI-DANDRUFF DRYNESS AND ITCH RELIEF 2 IN 1 SHAMPOO AND CONDITONER	Conopco d/b/a Unilever	4edfa86c-0139-5bc5-e063-6294a90a5d73	2026-04-07	Warnings	Exact identifier application number: M032
Dove	SOOTHING MOISTURE DAMAGE THERAPY ANTI-DANDRUFF SHAMPOO	Conopco d/b/a Unilever	4ecb2eac-0d1c-b59d-e063-6394a90a49e3	2026-04-06	Warnings	Exact identifier application number: M032
Happy Head Anti-Dandruff	PYRITHIONE ZINC	Happy Head, Inc	f0d5daea-72fc-4e40-a390-9da42cadbe3a	2026-04-06	Warnings	Exact identifier application number: M032
Dove	CALMING RELIEF DAMAGE THERAPY ANTI-DANDRUFF 2 IN 1 SHAMPOO AND CONDITIONER	Conopco d/b/a Unilever	4ecc1232-065f-c63e-e063-6394a90ac63b	2026-04-06	Warnings	Exact identifier application number: M032
Suave Professionals Men 2 in 1 Classic Clean AntiDandruff	PYRITHIONE ZINC	Conopco Inc. d/b/a Unilever	d85e52e5-c3e2-4be0-aa3f-3511a69ecc4f	2026-04-03	Warnings	Exact identifier application number: M032
Denorex Multi-Symptom Anti-Dandruff	SALICYLIC ACID	Neoteric Cosmetics, Inc.	4e904a6b-a732-558b-e063-6294a90ac642	2026-04-01	Warnings	Exact identifier application number: M032
Denorex Extra Strength	SALICYLIC ACID	Neoteric Cosmetics, Inc.	21d234ff-f379-4bcd-9ba0-90f27c6d3a69	2026-04-01	Warnings	Exact identifier application number: M032
EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00	EASYES ANTI DANDRUFF AND ANTI HAIR THINNING SHAMP00	Qingyuan Moksha Biotechnology Co., Ltd.	4e386cc8-004a-9742-e063-6394a90a763c	2026-03-30	Warnings	Exact identifier application number: M032
Tio Nacho Anti-Dandruff	SALICYLIC ACID	Genomma Lab USA	c3c92b35-4955-4985-9a1d-8756c1b2131c	2026-03-27	Warnings	Exact identifier application number: M032
Suave Antidandruff 2 IN 1 Classic Clean	ANTI DANDRUFF 2N1 SHAMPOO AND CONDITIONER	Suave Brands Co., LLC	41d9cfec-6d14-f620-e063-6294a90a078d	2026-03-26	Warnings	Exact identifier application number: M032
Suave Anti dandruff Coconut Moisture	ANTI DANDRUFF SHAMPOO	Suave Brands Co., LLC	41da3d90-4845-0d8f-e063-6294a90aede1	2026-03-26	Warnings	Exact identifier application number: M032
Suave Men 2 IN1 Scalp Defense	ANTI DANDRUFF SHAMPOO AND CONDITIONER	Suave Brands Co., LLC	42517082-4d0a-90a3-e063-6294a90a5927	2026-03-26	Warnings	Exact identifier application number: M032
Suave Men Antidandruff 2 IN 1 Classic Clean	ANTI DANDRUFF SHAMPOO AND CONDITIONER	Suave Brands Co., LLC	425264b9-62a9-fd7b-e063-6294a90a37a2	2026-03-26	Warnings	Exact identifier application number: M032
Pyrithione Zinc	PYRITHIONE ZINC	Nice-Pak Products, LLC	4db2aaf4-5caf-d9e5-e063-6294a90aa4ea	2026-03-23	Warnings, Adverse reactions	Exact identifier application number: M032
MG217 Psoriasis Medicated multi-symptom	COAL TAR	Wisconsin Pharmacal Company	7cb04d20-9b3c-27bb-e053-2a91aa0a5bc4	2026-03-20	Warnings	Exact identifier application number: M032
MG217 Psoriasis Therapeutic Conditioner	SALICYLIC ACID	Wisconsin Pharmacal Company	246f239f-16fb-24b2-e054-00144ff8d46c	2026-03-20	Warnings	Exact identifier application number: M032
Dermeleve Scalp Psoriasis Treatment	SALICYLIC ACID	Advanced Derm Solutions LLC	f55da7a8-0a26-4925-bd3b-fade6156116d	2026-03-19	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