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 22 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quality Choice Dandruff 2 in 1 PYRITHIONE ZINC CHAIN DRUG MARKETING ASSOCIATION, INC. 2c6289a3-2f09-c094-e063-6394a90a81f9 2025-01-23 Warnings Exact identifier application number: M032 Tuymec Anti-Fungal Shampoo. ANTI-FUNGAL SHAMPOO Guangzhou Zanming Trading Co., Ltd. 2c62d04e-dcb6-a33e-e063-6394a90a2e8e 2025-01-23 Warnings Exact identifier application number: M032 QC Anti Dandruff T Plus COAL TAR Chain Drug Marketing Association, Inc. 2bea5414-c7bc-d010-e063-6294a90aa138 2025-01-17 Warnings Exact identifier application number: M032 Meijer Medicated Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE Meijer Distribution, Inc 41b563c6-5df6-4ead-bddf-a69a07970ea0 2025-01-14 Warnings Exact identifier application number: M032 D-COL Personal Hygiene Convenience kit PYRITHIONE ZINC AND CHLOROXYLENOL D-COL Inc 273fcc6f-9c54-42b0-aa0c-9051457b1341 2025-01-14 Warnings Exact identifier application number: M032 Equate Mens Ultra Sport 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. f8767db7-e208-4ccc-85f7-789e281c7f26 2025-01-10 Warnings Exact identifier application number: M032 Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. c759b347-bdfb-4ff5-a464-b40fa2efb843 2025-01-10 Warnings Exact identifier application number: M032 Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. d561e8d2-2761-422b-8f05-ac76d3a043eb 2025-01-10 Warnings Exact identifier application number: M032 Royal Oils by Head and Shoulders Sulfate Free Scalp Care PYRITHIONE ZINC The Procter & Gamble Manufacturing Company d73ab807-027f-7581-e053-2995a90ada83 2025-01-08 Warnings Exact identifier application number: M032 Head and Shoulders Supreme Color Protect Conditioner PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 86ac3037-9ff2-25ea-e053-2a91aa0a43e3 2025-01-08 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC e5702ac7-e680-ab4b-e053-2995a90ad442 2025-01-01 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC abaf1c64-1c4d-481a-9872-b64fcf82cc63 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bdad4d-d499-70a9-e053-2a95a90a5cd9 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bf3852-e963-7a48-e053-2995a90a5aa1 2025-01-01 Warnings Exact identifier application number: M032 American Crew PYRITHIONE ZINC Revlon Consumer Products Corp 9566b567-90be-4803-b940-e6a91750778f 2024-12-30 Warnings Exact identifier application number: M032 Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff Treatment SALICYLIC ACID L'Oreal USA Products Inc. d72688ed-d153-4eed-988f-5386eb68559d 2024-12-30 Warnings Exact identifier application number: M032 Dermaharmony Seborrheic Dermatitis PYRITHIONE ZINC D3 Development, Inc. 8d81521d-9e6f-1acf-e053-2995a90a9242 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Sulfur and Salicylic Acid SALICYLIC ACID, SULFUR D3 Development, Inc. a1c61da2-7e7a-430a-e053-2995a90ad594 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint SALICYLIC ACID, SULFUR D3 Development, Inc. af7060a9-986c-500e-e053-2a95a90a6438 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint PYRITHIONE ZINC D3 Development, Inc. a19b74b0-88c6-6897-e053-2a95a90a7309 2024-12-20 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