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 5 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Recuren Plus Balanced Scalp	SALICYLIC ACID	REGENEREN PLUS LTD	50c27b0f-9bf5-de9c-e063-6394a90af41a	2026-05-04	Warnings	Exact identifier application number: M032
Mielle Lavender and Lychee Scalp Moisturizing	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	510212e9-1d12-3a0a-e063-6294a90a1d78	2026-05-04	Warnings	Exact identifier application number: M032
Mielle Lavender and Lychee Scalp Soothing Daily Refresher	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	51033795-843b-844a-e063-6394a90ad091	2026-05-04	Warnings	Exact identifier application number: M032
Mielle Lavender and Lychee Scalp Soothing Conditioner	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	5103ddfe-c5a1-3c4d-e063-6294a90aa462	2026-05-04	Warnings	Exact identifier application number: M032
Walgreens	SALICYLIC ACID	Walgreens	ec19b9b8-b97f-5277-e053-2a95a90a3c1e	2026-05-03	Warnings	Exact identifier application number: M032
Pyrithione Zinc	CVS	Apollo Health and Beauty Care	34047084-0b26-2385-e063-6394a90a204e	2026-05-03	Warnings	Exact identifier application number: M032
CVS Itchy Scalp	PYRITHIONE ZINC	Apollo Health and Beauty Care	372b25d8-10b0-a049-e063-6394a90a4f61	2026-05-03	Warnings	Exact identifier application number: M032
CVS ANTI DANDRUFF	PYRITHIONE ZINC	Apollo Health and Beauty Care	3415172f-5a31-1085-e063-6394a90aabdc	2026-05-03	Warnings	Exact identifier application number: M032
ProBliva Folliculitis .shampoo.	SELENIUMDISULFIDE 1%	CAVTECH HOLDING LLC	502caa29-f817-cc12-e063-6394a90a2240	2026-04-23	Warnings	Exact identifier application number: M032
Dermoia Dandruff	PYRITHIONE ZINC	Treasurewise LLC	7884bd3e-62ab-4fcd-8870-0a941c3feadb	2026-04-22	Warnings	Exact identifier application number: M032
BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM	HAIR GROWTH SERUM	Putian Licheng District Zhijiancheng Trading Co., Ltd.	409de2af-f6f6-8181-e063-6294a90a0b4b	2026-04-22	Warnings	Exact identifier application number: M032
Everyday Clean	PYRITHIONE ZINC	Amazon.com Services LLC	6a634331-eb08-4f18-8a57-692d08918082	2026-04-21	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Better Living Brands, LLC	eb1e3236-5981-46c3-ae06-bed61f02a328	2026-04-21	Warnings, Adverse reactions	Exact identifier application number: M032
Everyday Clean Dandruff	PYRITHIONE ZINC	Target Corporation	cc3df9d0-0c16-4176-99d7-d0aec2366f2c	2026-04-21	Warnings, Adverse reactions	Exact identifier application number: M032
2 in 1 Dandruff	PYRITHIONE ZINC	Target Corporation	a9d92e08-a77f-45dd-b95a-9923202df40b	2026-04-21	Warnings, Adverse reactions	Exact identifier application number: M032
Dove	PYRITHIONE ZINC	Conopco, Inc. d/b/a/ Unilever	7885a86b-f1a4-f2cc-e053-2991aa0ab677	2026-04-20	Warnings	Exact identifier application number: M032
Balancing	ZINC PYRITHIONE	Zero Flakes Given, Inc.	984780fd-4969-150b-e053-2995a90aed77	2026-04-16	Warnings	Exact identifier application number: M032
Restoring	PYRITHIONE ZINC	Zero Flakes Given, Inc.	4f9934e4-ec37-9f68-e063-6394a90ab9a4	2026-04-16	Warnings	Exact identifier application number: M032
Balancing	PYRITHIONE ZINC	Zero Flakes Given, Inc.	4f9a51ba-aea6-081f-e063-6394a90a4122	2026-04-16	Warnings	Exact identifier application number: M032
Dove Men Care	ANTI-DANDRUFF GENTLE CLEAN 2 IN 1 SHAMPOO AND CONDITIONER	Conopco d/b/a Unilever	4ef4b64f-e75d-a2ae-e063-6394a90abd80	2026-04-08	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