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 30 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Wal-Mart Stores, Inc.	78cabb38-9f9d-403d-b79c-ceedcea1812f	2023-11-20	Warnings	Exact identifier application number: M032
Aloe Coal 01	PYRITHIONE ZINC	T. SPRUILL, LLC	40a94657-6722-46b1-87ed-a15bf60ffc7a	2023-11-11	Warnings	Exact identifier application number: M032
HAIRCARE Physicians Recommended	SALICYLIC ACID	LAWRENCE E SAMUELS MD INC	095fcc1c-8f5b-47bd-a32a-7f5da5d162cd	2023-11-11	Warnings	Exact identifier application number: M032
Home Health Psoriasis Medicated Scalp and Body Wash	SALICYLIC ACID	Home Health	d10dad0e-34e1-49d4-a17a-36dbdbd66eb6	2023-11-06	Warnings	Exact identifier application number: M032
Glovers Therapeutic Care	SALICYLIC ACID	J. Strickland and Co.	bf101147-1408-4819-829a-6079f6448300	2023-11-05	Warnings	Exact identifier application number: M032
Sulfur 8 Medicated Dandruff with Salicylic Acid	SALICYLIC ACID	J. Strickland and Co.	14f41263-9999-448d-a479-abf67fb3b27b	2023-11-05	Warnings	Exact identifier application number: M032
Home Health Everclean Antidandruff	SALICYLIC ACID	Home Health	851ef329-f9be-4d50-87aa-b6c5eb3a2a89	2023-11-05	Warnings	Exact identifier application number: M032
Doo Gro Anti-Dandruff Vitalizer	SALICYLIC ACID	J. Strickland & Co. DBA Nature's Protein, Inc.	ad05695d-371d-4c38-8f78-b6736b505ab7	2023-10-31	Warnings	Exact identifier application number: M032
Doo Gro Anti-Dandruff Vitalizer	PYRITHIONE ZINC	J. Strickland & Co. DBA Nature's Protein, Inc.	7366c6f8-4cc2-520e-e053-2991aa0a2cc8	2023-10-31	Warnings	Exact identifier application number: M032
Compound W Total Care Wart and Skin Kit	SALICYLIC ACID	HK Kolmar Canada, Inc	def46762-990a-48b0-b702-15ece1dc541f	2023-10-27	Warnings	Exact identifier application number: M032
Satinique Anti Dandruff	PYRITHIONE ZINC	Access Business Group LLC	ae71967e-110d-4fae-a966-8382ca62bc1f	2023-10-23	Warnings	Exact identifier application number: M032
Glovers Anti-Dandruff	SULFUR, SALICYLIC ACID	J. Strickland & Co.	49fd4e03-736c-429a-8972-7302b732f816	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Oil Moisturizer Anti-Dandruff	PYRITHIONE ZINC	J. Strickland & Co.	abb85f88-78bb-4d84-9436-4616b31c63d1	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Anti-Dandruff Braid	SALICYLIC ACID	J. Strickland & Co.	d240be47-8b86-4836-8407-c9ffe44628e8	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Light Moisturizer Anti-Dandruff	PYRITHIONE ZINC	J. Strickland & Co.	8af5f208-f132-4e09-b353-ef12633ad350	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Fresh Anti-Dandruff Moisturizing	PYRITHIONE ZINC	J. Strickland & Co.	93c7c97b-7cd2-4d70-b437-6c175c8bab90	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Fresh Anti-Dandruff	SALICYLIC ACID	J. Strickland & Co.	5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Five Star Anti-Dandruff Hair Groom	PYRITHIONE ZINC	J. Strickland & Co.	bff46093-8186-4b2e-9363-03e67d04227a	2023-10-21	Warnings	Exact identifier application number: M032
Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing	PYRITHIONE ZINC	J. Strickland & Co.	9f1886c7-5a19-4706-83dc-828d7ed06b19	2023-10-21	Warnings	Exact identifier application number: M032
Glovers Dandruff Control Med., Floral	SULFUR	J. Strickland & Co.	a1224e4a-e811-4415-a038-3933da43d819	2023-10-21	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