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 20 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Structure of Skin Soothing Anti-Dandruff PYRITHIONE ZINC STRUCTURE OF SKIN LLC 3311fa83-a06b-b379-e063-6394a90ae269 2025-04-18 Warnings Exact identifier application number: M032 LILIVERA Hair Regrowth Kit MINOXIDIL Guangzhou Haishi Biological Technology Co., Ltd. 330602da-ec17-5a35-e063-6394a90a741b 2025-04-17 Warnings Exact identifier application number: M032 Head and Shoulders Clinical Strength Dry Scalp Rescue SELENIUM SULFIDE The Procter & Gamble Manufacturing Company 3272a482-3813-63e4-e063-6394a90a43eb 2025-04-10 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse for normal hair PYRITHIONE ZINC Rejoice International Inc. b90e574c-933c-4f86-aadc-567ffbe6ea04 2025-04-09 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse for sensitive hair PYRITHIONE ZINC Rejoice International Inc. 979394c2-5681-44c8-a43c-bf3a392bd0c1 2025-04-09 Warnings Exact identifier application number: M032 LEAHUE MADHUCA TONIC SALICYLIC ACID Bio-interchange Co. 31ee4645-0f64-f7a0-e063-6394a90a1736 2025-04-04 Warnings Exact identifier application number: M032 LEAHUE MADHUCA SALICYLIC ACID Bio-interchange Co. 81470dfe-f063-9d16-e053-2a91aa0a1829 2025-04-04 Warnings Exact identifier application number: M032 Kenkoderm Psoriasis Moisturizing SALICYLIC ACID Nexgel,Inc. 31ce20a2-95ae-e424-e063-6394a90af18a 2025-04-01 Warnings Exact identifier application number: M032 Kenkoderm Psoriasis SALICYLIC ACID Nexgel,Inc. 31cf90e5-0f21-903d-e063-6394a90a075d 2025-04-01 Warnings Exact identifier application number: M032 nioxin PRO CLINICAL SCALP RECOVERY scalp soothing serum PYRITHIONE ZINC The Wella Corporation 31af9365-e1a3-7203-e063-6294a90a8ade 2025-03-31 Warnings Exact identifier application number: M032 Listarfe Anti-Dandruff Shampoo. ANTI-DANDRUFF SHAMPOO Guangzhou Zanming Trading Co., Ltd. 3163eee0-379f-1f88-e063-6294a90a58ce 2025-03-28 Warnings Exact identifier application number: M032 anti dandruff SHAMPOOS PYRITHIONE ZINC Guangdong Quaker Daily Chemical Co., LTD 31392f0f-a6c4-1cfb-e063-6294a90a4d36 2025-03-26 Warnings Exact identifier application number: M032 anti dandruff SHAMPOOS PYRITHIONE ZINC Guangdong Quaker Daily Chemical Co., LTD 313716f7-6dd2-e1c5-e063-6394a90a9de3 2025-03-25 Warnings Exact identifier application number: M032 CeraVe Anti Dandruff Hydrating PYRITHIONE ZINC L'Oreal USA Products Inc 422e743b-fd77-40ed-8c5d-7f05112a447f 2025-03-24 Warnings Exact identifier application number: M032 Scalp Revival SALICYLIC ACID 3% Beccair, LLC 0a77e90e-a33a-43f3-80a0-a16a6902a735 2025-03-21 Warnings Exact identifier application number: M032 Gold Bond Psoriasis Relief Medicated Multi-Symptom SALICYLIC ACID Chattem, Inc. e8479bbc-5f49-41f2-851e-a93543516639 2025-03-19 Warnings Exact identifier application number: M032 13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and Mint PYRITHIONE ZINC Rejoice International Corp. 308554c2-938b-f0b5-e063-6394a90a5bfa 2025-03-17 Warnings Exact identifier application number: M032 13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa Butter PYRITHIONE ZINC Rejoice International Corp. 3086d31e-54ef-9c0f-e063-6394a90abdff 2025-03-17 Warnings Exact identifier application number: M032 SA Scalp Therapy SA SCALP Milbar Laboratories 304db1ab-acd7-43d5-e063-6294a90aeec2 2025-03-14 Warnings Exact identifier application number: M032 Neutrogena Scalp Therapy Anti-Dandruff Itchy Scalp SALICYLIC ACID Kenvue Brands LLC ca4c0d63-50b3-169f-e053-2a95a90acbcd 2025-03-10 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