Home NDC 52389-166-01 Psoriasin Gel
Product NDC 52389-166
Requested package NDC 52389-166-01
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52389-166 52389-166-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 Uploaded 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
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