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 28 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Anti-Dandruff Conditioner Coconut and Shea Butter PYRITHIONE ZINC Rejoice International Inc. e69319c8-c49c-415b-a7ea-ec6e77fa625c 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Conditioner mint and eucalyptus PYRITHIONE ZINC Rejoice International Inc. 08330f44-45e2-47cb-bd2e-cef15ba61aee 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse Coconut and Shea Butter PYRITHIONE ZINC Rejoice International Inc. 7d9bf611-db24-4915-9b13-b7b36f47711f 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Anti-Dandruff Hair Cleanse mint and eucalyptus PYRITHIONE ZINC Rejoice International Inc. b05742fe-692f-45a3-9de0-5f3f08642d78 2024-02-28 Warnings Exact identifier application number: M032 XtraCare Dandruff Hair Wash SALICYLIC ACID Rejoice International 1902e6bb-e829-4b1a-b85a-1394913c77ca 2024-02-28 Warnings Exact identifier application number: M032 amazon basics maximum strength dandruff Anti-dandruff SELENIUM SULFIDE AMAZON.COM SERVICES LLC 194e4c51-ff7b-4def-a71d-efa5dfca3efd 2024-02-26 Warnings Exact identifier application number: M032 Doo Gro Braids Twists Locs Dandruff Control Moisturizing SALICYLIC ACID J. Strickland and Co. 116f4f0d-66c7-49dd-e063-6394a90ab2b5 2024-02-15 Warnings Exact identifier application number: M032 amazon basics therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR AMAZON.COM SERVICES LLC ada1be0c-53a7-443c-bc3c-f7a26b5f96a9 2024-02-05 Warnings Exact identifier application number: M032 Equate Dry Scalp 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 6440fdd9-daa8-4f15-bdee-33724993bd7b 2024-02-01 Warnings Exact identifier application number: M032 Equate Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 4c84a67a-1f43-4f40-a172-271de7e76785 2024-01-29 Warnings Exact identifier application number: M032 Equate Everyday Clean 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. c85095f2-5dbd-4822-a83a-dc3641c4a330 2024-01-29 Warnings Exact identifier application number: M032 Hydrocortisone ANTIPRURITIC (ANTI-ITCH) Dynarex Corporation 81dff9df-6f7e-49f0-e053-2a91aa0af7e7 2024-01-23 Warnings Exact identifier application number: M032 Walgreens Original T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Walgreen Company 42cc63ab-6f79-4544-8529-7b8c36021b18 2024-01-22 Warnings Exact identifier application number: M032 True plus Real Therapeutic T plus Plus Original Strength Tar Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Garcoa, Inc. 1f4c23d5-ca00-4387-abc7-59d9ef471977 2024-01-22 Warnings Exact identifier application number: M032 Walgreens Extra Strength T-Gel Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Walgreen Company 7f681386-976c-40f4-8b18-97413989ab78 2024-01-22 Warnings Exact identifier application number: M032 Prosoria Medicated SELENIUM SULFIDE Nuvothera, Inc. 44eaaeb0-1400-4697-85d0-e8c2282c1cba 2024-01-11 Warnings Exact identifier application number: M032 Prosoria Scalp SALICYLIC ACID Nuvothera, Inc. 52a98715-3e57-4b86-b91e-0ce433dc22bd 2024-01-10 Warnings Exact identifier application number: M032 Prosoria Psoriasis Treatment SALICYLIC ACID Nuvothera, Inc. f94f4481-c58e-4555-9863-cbaa2c4cdd07 2024-01-10 Warnings Exact identifier application number: M032 Equate Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 408d57e4-a707-4826-a04c-99517dc9b5af 2024-01-04 Warnings Exact identifier application number: M032 Equate Extra Strength Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 986ac1ab-c7c3-40df-b41b-6f26cce22a43 2024-01-04 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