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 18 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Head and Shoulders Bare Minimal Ingredients Itchy Scalp Relief Serum	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	402e2561-e309-46f2-e063-6394a90a4e58	2025-10-02	Warnings	Exact identifier application number: M032
J1002902 Jason Dandruff Relief 2in1 Treatment	PYRITHIONE ZINC	The Hain Celestial Group Inc	8c631014-3832-78cb-e053-2995a90a8d22	2025-10-01	Warnings	Exact identifier application number: M032
iBeaLee 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	40001edd-d98c-4e2a-e063-6394a90a9911	2025-09-30	Warnings	Exact identifier application number: M032
Head and Shoulders Dry Scalp Complete Hydration 2in1	PYRITHIONE ZINC	The Procter & Gamble Manufacturing Company	3f66839a-0d8f-e476-e063-6294a90a547c	2025-09-22	Warnings	Exact identifier application number: M032
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	1eae27bc-1b18-ae5d-e063-6394a90a4610	2025-09-12	Warnings	Exact identifier application number: M032
Head and Shoulders Clinical Strength Dandruff Defense Advanced Oil Control	SELENIUM SULFIDE	The Procter & Gamble Manufacturing Company	b6ad107b-024b-828f-e053-2995a90aae36	2025-09-04	Warnings	Exact identifier application number: M032
Hermon Folliculitis Shampoo.	SALICYLIC ACID 2%	Beautivity LLC	3c5f7caa-a4af-2574-e063-6394a90a7507	2025-08-14	Warnings	Exact identifier application number: M032
Pert 2 in 1 Advanced plus	SALICYLIC ACID	Sodalis USA, LLC	0eaed46c-ae6f-0d58-e063-6394a90ad2a3	2025-08-13	Warnings	Exact identifier application number: M032
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing Bar	PYRITHIONE ZINC 2%	RoyceDerm LLC	3b98a83d-9c3b-9522-e063-6294a90a7033	2025-08-05	Warnings	Exact identifier application number: M032
Earthmed FS Psoriasis relief	SALICYLIC ACID	Earthmed LLC	3ba584bc-f40a-ce0a-e063-6394a90aebf7	2025-08-05	Warnings	Exact identifier application number: M032
Pert 2 in 1 Extra Strength	SALICYLIC ACID	Sodalis USA, LLC	25c8a46c-4400-709f-e063-6394a90a3f31	2025-07-30	Warnings	Exact identifier application number: M032
anti-fungal	ANTI-FUNGAL SHAMPOO	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	3b102d15-f2ce-5727-e063-6294a90a23a9	2025-07-29	Warnings	Exact identifier application number: M032
Earthmed Sport Anti itch and eczema relief	SALICYLIC ACID	Earthmed LLC	3b14913b-3aab-9dd0-e063-6394a90a3b7f	2025-07-29	Warnings	Exact identifier application number: M032
Soothing psoriasis and eczema relief	SALICYLIC ACID	Carolina Cannabis Creations L.L.C	2bcad94d-1918-7f37-e063-6294a90a4744	2025-07-29	Warnings	Exact identifier application number: M032
DANDRX ANTI-DANDRUFF	ZINC PYRITHIONE	dandRX LLC	399fb507-2263-962f-e063-6394a90ae9a8	2025-07-10	Warnings	Exact identifier application number: M032
anti-dandruff	ANTI-DANDRUFF SHAMPOO	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	3979fb80-8091-c79e-e063-6394a90ae618	2025-07-09	Warnings	Exact identifier application number: M032
CeraVe 2 in 1 Anti-Dandruff Hydrating Conditioner	PYRITHIONE ZINC	LOreal USA Products Inc	7f5ff142-15cb-44be-aa0e-ccd06de23300	2025-07-08	Warnings	Exact identifier application number: M032
5% Minoxidil and 5% Rosemary for Hair Care	MINOXIDIL	TIKNOW LLC	1bb386d2-70c6-c487-e063-6294a90a19da	2025-07-07	Warnings	Exact identifier application number: M032
Red Scalpfixer Anti Dandruff	PYRINTHIONE ZINC	Orange Lab, Inc	386c83c3-8d23-b3b0-e063-6394a90a27ee	2025-07-01	Warnings	Exact identifier application number: M032
Dermabon Multi Symptom Psoriasis Control	COAL TAR	Dermabon de Chihuahua, S.A. de C.V.	d5b739ba-e332-41f6-9343-6ad5cc981344	2025-07-01	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