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 28 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter	PYRITHIONE ZINC	Rejoice International Inc.	e69319c8-c49c-415b-a7ea-ec6e77fa625c	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Conditioner mint and eucalyptus	PYRITHIONE ZINC	Rejoice International Inc.	08330f44-45e2-47cb-bd2e-cef15ba61aee	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter	PYRITHIONE ZINC	Rejoice International Inc.	7d9bf611-db24-4915-9b13-b7b36f47711f	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus	PYRITHIONE ZINC	Rejoice International Inc.	b05742fe-692f-45a3-9de0-5f3f08642d78	2024-02-28	Warnings	Exact identifier application number: M032
XtraCare Dandruff Hair Wash	SALICYLIC ACID	Rejoice International	1902e6bb-e829-4b1a-b85a-1394913c77ca	2024-02-28	Warnings	Exact identifier application number: M032
amazon basics maximum strength dandruff Anti-dandruff	SELENIUM SULFIDE	AMAZON.COM SERVICES LLC	194e4c51-ff7b-4def-a71d-efa5dfca3efd	2024-02-26	Warnings	Exact identifier application number: M032
Doo Gro Braids Twists Locs Dandruff Control Moisturizing	SALICYLIC ACID	J. Strickland and Co.	116f4f0d-66c7-49dd-e063-6394a90ab2b5	2024-02-15	Warnings	Exact identifier application number: M032
amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	AMAZON.COM SERVICES LLC	ada1be0c-53a7-443c-bc3c-f7a26b5f96a9	2024-02-05	Warnings	Exact identifier application number: M032
Equate Dry Scalp 2 in 1 Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	6440fdd9-daa8-4f15-bdee-33724993bd7b	2024-02-01	Warnings	Exact identifier application number: M032
Equate Everyday Clean Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	4c84a67a-1f43-4f40-a172-271de7e76785	2024-01-29	Warnings	Exact identifier application number: M032
Equate Everyday Clean 2 in 1 Dandruff Anti-Dandruff	PYRITHIONE ZINC	Wal-Mart Stores, Inc.	c85095f2-5dbd-4822-a83a-dc3641c4a330	2024-01-29	Warnings	Exact identifier application number: M032
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	Dynarex Corporation	81dff9df-6f7e-49f0-e053-2a91aa0af7e7	2024-01-23	Warnings	Exact identifier application number: M032
Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Walgreen Company	42cc63ab-6f79-4544-8529-7b8c36021b18	2024-01-22	Warnings	Exact identifier application number: M032
True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Garcoa, Inc.	1f4c23d5-ca00-4387-abc7-59d9ef471977	2024-01-22	Warnings	Exact identifier application number: M032
Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Walgreen Company	7f681386-976c-40f4-8b18-97413989ab78	2024-01-22	Warnings	Exact identifier application number: M032
Prosoria Medicated	SELENIUM SULFIDE	Nuvothera, Inc.	44eaaeb0-1400-4697-85d0-e8c2282c1cba	2024-01-11	Warnings	Exact identifier application number: M032
Prosoria Scalp	SALICYLIC ACID	Nuvothera, Inc.	52a98715-3e57-4b86-b91e-0ce433dc22bd	2024-01-10	Warnings	Exact identifier application number: M032
Prosoria Psoriasis Treatment	SALICYLIC ACID	Nuvothera, Inc.	f94f4481-c58e-4555-9863-cbaa2c4cdd07	2024-01-10	Warnings	Exact identifier application number: M032
Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Wal-Mart Stores, Inc.	408d57e4-a707-4826-a04c-99517dc9b5af	2024-01-04	Warnings	Exact identifier application number: M032
Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	Wal-Mart Stores, Inc.	986ac1ab-c7c3-40df-b41b-6f26cce22a43	2024-01-04	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