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 25 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer T Plus Gel Coal Tar Anti-Dandruff	COAL TAR	Meijer Distribution, Inc	c4b0d6e5-0756-45e8-bdfc-a8ba728b246b	2024-11-05	Warnings	Exact identifier application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruff	PYRITHIONE ZINC	Walgreen Company	52594e2b-dd1b-4618-b1ab-9f65ae26a358	2024-11-04	Warnings	Exact identifier application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Anti-dandruff	PYRITHIONE ZINC	Walgreen Company	12ccb5aa-4e0d-467b-a03c-dddd6da0a9c9	2024-11-04	Warnings	Exact identifier application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Dry Scalp Anti-dandruff	PYRITHIONE ZINC	Walgreen Company	0fed00b3-cac6-4add-b979-a3fe112bcff3	2024-11-04	Warnings	Exact identifier application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Anti-dandruff	PYRITHIONE ZINC	Walgreen Company	06b37d44-9ebf-44ed-8e8b-492905d85bdc	2024-11-01	Warnings	Exact identifier application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruff	PYRITHIONE ZINC	Walgreen Company	5b679112-8790-416f-9bb4-8e64d3e279bc	2024-11-01	Warnings	Exact identifier application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Plus Vitamins and Botanicals Anti-dandruff	SALICYLIC ACID	Walgreen Company	2776d45c-6597-4c13-81e6-29d9248e9e56	2024-11-01	Warnings	Exact identifier application number: M032
Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruff	SELENIUM SULFIDE	Walgreen Company	dbcaeae8-4680-41d8-84e2-896183d2121d	2024-11-01	Warnings	Exact identifier application number: M032
Walgreens Dandruff Maximum Strength Anti-dandruff	SELENIUM SULFIDE	Walgreen Company	0187b034-44d7-4b84-af04-d018bc9750f3	2024-11-01	Warnings	Exact identifier application number: M032
Dermarest Psoriasis Medicated	SALICYLIC ACID	Insight Pharmaceuticals LLC	c6a64946-bafd-449f-90cc-e2f6201285f3	2024-10-25	Warnings	Exact identifier application number: M032
DermaSolve Medicated	SALICYLIC ACID	Fortitude Health, LLC	253e2687-6e8b-48ec-e063-6394a90aa20b	2024-10-24	Warnings	Exact identifier application number: M032
FAMILY Wellness FRESH and CLEAN DANDRUFF PLUS CONDITIONER 2 IN 1 Anti-Dandruff	PYRITHIONE ZINC	FAMILY DOLLAR SERVICES INC	4a9a803a-44ac-4e29-9c47-0073b728ff19	2024-10-22	Warnings	Exact identifier application number: M032
DermaSolve Medicated	SALICYLIC ACID	Fortitude Health, LLC	24fea3b2-1f0a-e289-e063-6394a90a5641	2024-10-21	Warnings	Exact identifier application number: M032
FAMILY Wellness EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-Dandruff	PYRITHIONE ZINC	FAMILY DOLLAR SERVICES INC	220955ec-592c-421f-9f4e-545ff3843ee0	2024-10-21	Warnings	Exact identifier application number: M032
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	SELENIUM SULFIDE	FAMILY DOLLAR SERVICES INC	41a808e1-67a7-4b29-8ec4-d6c13cf62243	2024-10-21	Warnings	Exact identifier application number: M032
Family Wellness Therapeutic Tplus PLUS Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis	COAL TAR	FAMILY DOLLAR SERVICES INC	46471dfa-2322-464f-8d00-bf49d8eb4e18	2024-10-21	Warnings	Exact identifier application number: M032
As I Am Dry and Itchy Scalp Care Conditioner	PYRITHIONE ZINC	Salon Commodities, Inc.	71eb9451-df12-66e8-e053-2a95a90a2f69	2024-10-09	Warnings	Exact identifier application number: M032
As I Am Dry and Itchy Scalp Care Treatment	SALICYLIC ACID	Salon Commodities, Inc.	71ec25c5-6da5-670a-e053-2a95a90a1b8c	2024-10-09	Warnings	Exact identifier application number: M032
KeraCare Dry and Itchy Scalp Anti-Dandruff	PYRITHIONE ZINC	Avlon Industries, Inc.	6e7524d7-b280-485a-815e-8af078e8acda	2024-10-09	Warnings	Exact identifier application number: M032
KeraCare Dry and Itchy Scalp Anti-Dandruff	PYRITHIONE ZINC	Avlon Industries, Inc.	5d501ba0-a6f9-4f0d-86d5-0e8d9302737f	2024-10-09	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