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 2 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join apgwgzminoxidil2% MINOXIDIL Guangdong Jiaoyu Biotechnology Co., Ltd 5957c990-e274-6278-e063-6394a90af2b7 2026-08-18 Warnings Exact identifier application number: M032 EVERYDAY CLEAN DANDRUFF PYRITHIONE ZINC Universal Distribution Center LLC 3983b688-28ae-462e-8686-6cf2f2c1cca4 2026-08-18 Warnings Exact identifier application number: M032 Prosoria Psoriasis Treatment SALICYLIC ACID Nuvothera, Inc. 378311aa-95f7-4c69-bc00-e688468262bd 2026-08-18 Warnings Exact identifier application number: M032 RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream SALICYLIC ACID 3% RoyceDerm LLC 496e178b-e29b-071e-e063-6394a90aa018 2026-08-13 Warnings Exact identifier application number: M032 RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo. SALICYLIC ACID 3% RoyceDerm LLC 4995ce33-e231-8f86-e063-6394a90af486 2026-08-13 Warnings Exact identifier application number: M032 Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief PYRITHIONE ZINC Rida LLC d1e4dee7-5962-4ec1-ab99-9d547077b2f2 2026-08-05 Warnings Exact identifier application number: M032 Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief Treatment SALICYLIC ACID Rida LLC 6226ce12-432f-402e-bda7-a5ca96f0b838 2026-08-05 Warnings Exact identifier application number: M032 JOHNSON FOAM MINOXIDIL JOHNSON BIOPHARMACEUTICAL INC. 1d44a75c-c940-680c-e063-6394a90a5839 2026-08-02 Warnings Exact identifier application number: M032 EVERYDAY CLEAN DANDRUFF PYRITHIONE ZINC NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5a03d4bb-72e6-cc9f-e063-6394a90ae19f 2026-08-01 Warnings Exact identifier application number: M032 TEA TREE Oil DANDRUFF PYRITHIONE ZINC NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5a0505a6-77ca-c56e-e063-6394a90aea6f 2026-08-01 Warnings Exact identifier application number: M032 ITCHY SCALP RELIEF DANDRUFF PYRITHIONE ZINC NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5a0521cd-2b9e-e02c-e063-6394a90a5f02 2026-08-01 Warnings Exact identifier application number: M032 SMOOTH AND SOFT DANDRUFF PYRITHIONE ZINC NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. 5a054179-b0d7-3a0f-e063-6294a90a6209 2026-08-01 Warnings Exact identifier application number: M032 FOLKI COSMETIC Psoriasis Cream SALICYLIC ACID 3% PSORIASIS CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 575786e0-21b8-ad9d-e063-6394a90ad0d4 2026-07-24 Warnings Exact identifier application number: M032 RoyceDerm Psoriasis Scalp .spray. SALICYLIC ACID 2% RoyceDerm LLC 57425b1a-4cf3-b133-e063-6394a90a84f5 2026-07-23 Warnings Exact identifier application number: M032 RoyceDerm Psoriasis Scalp .Shampoo. SALICYLIC ACID 3% RoyceDerm LLC 5743f813-57f7-f544-e063-6294a90ad3b8 2026-07-23 Warnings Exact identifier application number: M032 Yodo Salil OINTMENT Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA. 56812625-7eab-6a25-e063-6294a90a23fe 2026-07-20 Warnings Exact identifier application number: M032 Pureskin Seborrheic Dermatitis and Psoriasis Cream SEBORRHEIC DERMATITIS PSORIASIS CREAM BENLONG HALL LLC 36086f7f-8536-417f-a302-37f78288489e 2026-07-20 Warnings Exact identifier application number: M032 5%MINOXIDIL TOPICAL FOAM MINOXIDIL Veloce Trading Co., Limited 56f87881-653f-17e6-e063-6294a90a6787 2026-07-19 Warnings Exact identifier application number: M032 ProBliva Psoriasis Shampoo. SALICYLIC ACID 3% CAVTECH HOLDING LLC 563e75f9-a1e2-2796-e063-6294a90aedb4 2026-07-10 Warnings Exact identifier application number: M032 ProBliva Anti Dandruff Shampoo. SELENIUM SULFIDE 1% CAVTECH HOLDING LLC 56022f6b-d7ba-1ccd-e063-6294a90a7310 2026-07-07 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