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 23 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermaharmony Face and Body PYRITHIONE ZINC D3 Development, Inc. bd72b53c-b22c-40d0-e053-2995a90af9c1 2024-12-20 Warnings Exact identifier application number: M032 Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. 637851c6-ff4a-8bbc-e053-2991aa0a963c 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. cb442483-b735-01a0-e053-2995a90aaff5 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Pyrithione Zinc with Shea Butter PYRITHIONE ZINC D3 Development, Inc. dc7ba02c-bdbd-5136-e053-2995a90ac545 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Tea Tree Bar PYRITHIONE ZINC D3 Development, Inc. e9d5eb14-1840-ae21-e053-2a95a90aa321 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Unscented Bar PYRITHIONE ZINC D3 Development, Inc. e9d66c9c-5fb1-0a90-e053-2a95a90ab7a4 2024-12-20 Warnings Exact identifier application number: M032 BYE-BYE CRADLE CAP PYRITHIONE ZINC Tubby Todd f4398ad2-7da5-aff0-e053-2995a90ae266 2024-12-12 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF PYRITHIONE ZINC Davines S.p.A. 1f7e0265-0543-4ef9-addf-4d514d0eedfe 2024-12-11 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE Davines S.p.A. 369a24fd-3882-4fad-b57a-45806090aff1 2024-12-11 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs b5ea8f33-8f18-7464-e053-2a95a90a39b2 2024-12-09 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs fa54cf42-3ba7-b7b3-e053-6394a90aa7a0 2024-12-09 Warnings Exact identifier application number: M032 Satinique Anti Dandruff Scalp and Hair SALICYLIC ACID Access Business Group LLC 03252c61-c51b-4e87-a06d-a61b8393704f 2024-12-09 Warnings Exact identifier application number: M032 Dry Skin Relief Bar SALICYLIC ACID CP Skin Health Group, Inc. eceb73b0-4c2f-4989-a3aa-a6553bc68252 2024-12-09 Warnings Exact identifier application number: M032 Head and Shoulders Dual Pack Green Apple PYRITHIONE ZINC The Procter & Gamble Manufacturing Company c8208bac-9d32-7694-e053-2a95a90a746c 2024-11-27 Warnings Exact identifier application number: M032 Vanicream PYRITHIONE ZINC Pharmaceutical Specialties, Inc. d124a093-f739-0666-e053-2995a90a52ed 2024-11-27 Warnings Exact identifier application number: M032 LEAHUE MADHUCA TONIC SALICYLIC ACID Bio-interchange Co. 81454c8a-ddcf-7cef-e053-2991aa0a53c2 2024-11-27 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Oily, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. b09c3b0d-564e-45e4-b6ff-c1f0c12a9521 2024-11-13 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Dry, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. fa5d4ee3-fbeb-4379-bbd3-2b5b2cc45430 2024-11-12 Warnings Exact identifier application number: M032 Marcs 2 in 1 Everyday Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. 1daaa2c9-fbc7-4aa5-9772-e15710932066 2024-11-11 Warnings Exact identifier application number: M032 Marcs Dry Scalp Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. ffab6ca6-7c8f-4080-836c-635a6ba3c0bb 2024-11-11 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