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 21 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena Scalp Therapy Anti-Dandruff Extra Strength	SALICYLIC ACID	Kenvue Brands LLC	ca49fd70-f0d3-3375-e053-2a95a90af835	2025-03-10	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Coastal Tide	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	20d3208c-d22b-84f1-e063-6394a90ab610	2025-03-06	Warnings	Exact identifier application number: M032
Head and Shoulders Supreme Nourish and Smooth Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	86abb2ee-6b35-32eb-e053-2a91aa0a8bc6	2025-03-03	Warnings	Exact identifier application number: M032
Cantu Guava Ginger Anti Dandruff	SALICYLIC ACID	PDC Brands	d43a540b-bea5-2055-e053-2995a90a25fb	2025-03-03	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 MenTimber Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2d7ff3d8-d142-9537-e063-6294a90ab02c	2025-02-06	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Clinical Strength Dry Scalp Rescue	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2d041983-5750-e0f1-e063-6394a90a5b9e	2025-01-31	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Vanilla and Amber	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cf441e0-3ddd-0f9e-e063-6394a90a092c	2025-01-30	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and Thick	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3f0664-a9e7-6b63-e053-2991aa0a4b0a	2025-01-29	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Care Dual Pack	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cdb1e94-3923-84f7-e063-6394a90a07d5	2025-01-29	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	2cc7724c-a1f1-a42d-e063-6394a90a83cf	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old Spice	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	7d3cca83-f99e-2c30-e053-2991aa0a4c9d	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	2ccaceed-9928-ef05-e063-6394a90a6511	2025-01-28	Warnings	Exact identifier application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing Hydration	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	003d1723-1fd9-ef2b-e063-6294a90aafda	2025-01-28	Warnings	Exact identifier application number: M032
QC Anti Dandruff T Plus	COAL TAR	Guangzhou Danting Bath&Body Care Industry Co. Ltd.	2c7630ab-b7fa-462c-e063-6394a90a30bb	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff 2 in 1	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd	2c762c86-ba7a-1976-e063-6394a90a49f2	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Dry Scalp Care	PYRITHIONE ZINC	CHAIN DRUG MARKETING ASSOCIATION, INC.	2c764242-df65-7383-e063-6394a90a34b0	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Everyday Clean	PYRITHIONE ZINC	CHAIN DRUG MARKETING ASSOCIATION, INC.	2c767d79-6ffe-ebaa-e063-6394a90a39d1	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Everyday Clean	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd	2c77edae-be2b-3a37-e063-6294a90a001d	2025-01-24	Warnings	Exact identifier application number: M032
Quality Choice Dandruff Dry Scalp Care	PYRITHIONE ZINC	Guangzhou Danting Bath&Body Care Industry Co. Ltd.	2c77e4b6-5a65-c7ea-e063-6394a90a6abb	2025-01-24	Warnings	Exact identifier application number: M032
Zincon Medicated Anti-Dandruff	PYRITHIONE ZINC	Neoteric Cosmetics, Inc.	2c26bd1e-35d4-f1a2-e063-6294a90af576	2025-01-23	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