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 30 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 78cabb38-9f9d-403d-b79c-ceedcea1812f 2023-11-20 Warnings Exact identifier application number: M032 Aloe Coal 01 PYRITHIONE ZINC T. SPRUILL, LLC 40a94657-6722-46b1-87ed-a15bf60ffc7a 2023-11-11 Warnings Exact identifier application number: M032 HAIRCARE Physicians Recommended SALICYLIC ACID LAWRENCE E SAMUELS MD INC 095fcc1c-8f5b-47bd-a32a-7f5da5d162cd 2023-11-11 Warnings Exact identifier application number: M032 Home Health Psoriasis Medicated Scalp and Body Wash SALICYLIC ACID Home Health d10dad0e-34e1-49d4-a17a-36dbdbd66eb6 2023-11-06 Warnings Exact identifier application number: M032 Glovers Therapeutic Care SALICYLIC ACID J. Strickland and Co. bf101147-1408-4819-829a-6079f6448300 2023-11-05 Warnings Exact identifier application number: M032 Sulfur 8 Medicated Dandruff with Salicylic Acid SALICYLIC ACID J. Strickland and Co. 14f41263-9999-448d-a479-abf67fb3b27b 2023-11-05 Warnings Exact identifier application number: M032 Home Health Everclean Antidandruff SALICYLIC ACID Home Health 851ef329-f9be-4d50-87aa-b6c5eb3a2a89 2023-11-05 Warnings Exact identifier application number: M032 Doo Gro Anti-Dandruff Vitalizer SALICYLIC ACID J. Strickland & Co. DBA Nature's Protein, Inc. ad05695d-371d-4c38-8f78-b6736b505ab7 2023-10-31 Warnings Exact identifier application number: M032 Doo Gro Anti-Dandruff Vitalizer PYRITHIONE ZINC J. Strickland & Co. DBA Nature's Protein, Inc. 7366c6f8-4cc2-520e-e053-2991aa0a2cc8 2023-10-31 Warnings Exact identifier application number: M032 Compound W Total Care Wart and Skin Kit SALICYLIC ACID HK Kolmar Canada, Inc def46762-990a-48b0-b702-15ece1dc541f 2023-10-27 Warnings Exact identifier application number: M032 Satinique Anti Dandruff PYRITHIONE ZINC Access Business Group LLC ae71967e-110d-4fae-a966-8382ca62bc1f 2023-10-23 Warnings Exact identifier application number: M032 Glovers Anti-Dandruff SULFUR, SALICYLIC ACID J. Strickland & Co. 49fd4e03-736c-429a-8972-7302b732f816 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Oil Moisturizer Anti-Dandruff PYRITHIONE ZINC J. Strickland & Co. abb85f88-78bb-4d84-9436-4616b31c63d1 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Anti-Dandruff Braid SALICYLIC ACID J. Strickland & Co. d240be47-8b86-4836-8407-c9ffe44628e8 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Light Moisturizer Anti-Dandruff PYRITHIONE ZINC J. Strickland & Co. 8af5f208-f132-4e09-b353-ef12633ad350 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff Moisturizing PYRITHIONE ZINC J. Strickland & Co. 93c7c97b-7cd2-4d70-b437-6c175c8bab90 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff SALICYLIC ACID J. Strickland & Co. 5acd1aab-3a6d-4d2c-8c80-271ab8dcac1a 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Five Star Anti-Dandruff Hair Groom PYRITHIONE ZINC J. Strickland & Co. bff46093-8186-4b2e-9363-03e67d04227a 2023-10-21 Warnings Exact identifier application number: M032 Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing PYRITHIONE ZINC J. Strickland & Co. 9f1886c7-5a19-4706-83dc-828d7ed06b19 2023-10-21 Warnings Exact identifier application number: M032 Glovers Dandruff Control Med., Floral SULFUR J. Strickland & Co. a1224e4a-e811-4415-a038-3933da43d819 2023-10-21 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