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 26 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join As I Am Dry and Itchy Scalp Care PYRITHIONE ZINC Salon Commodities, Inc. 71ea4820-4160-41c2-e053-2a95a90a127d 2024-10-09 Warnings Exact identifier application number: M032 As I Am Dry and Itchy Scalp Care Co Wash PYRITHIONE ZINC Salon Commodities, Inc. 71edee79-87ed-ff7c-e053-2995a90ae130 2024-10-09 Warnings Exact identifier application number: M032 Vanicream Z-Bar PYRITHIONE ZINC Pharmaceutical Specialties, Inc. 21c84000-5d08-ae53-e063-6294a90a2362 2024-10-03 Warnings Exact identifier application number: M032 Head and Shoulders Classic Clean Dandruff PYRITHIONE ZINC Navajo Manufacturing Company Inc 3886d51a-b946-4862-a237-e8232df95637 2024-10-02 Warnings Exact identifier application number: M032 CVS Daily Dandruff Anti-dandruff PYRITHIONE ZINC CVS Health 705f5ced-a245-42c8-a32f-baaddaa11c6e 2024-09-27 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID CVS Health bd32def7-b002-4e12-89ad-b7d13754d82a 2024-09-24 Warnings Exact identifier application number: M032 CVS Health MAXIMUM STRENGTH Dandruff Anti-Seborrheic Dermatitis, anti-dandruff SELENIUM SULFIDE CVS Health cff51af6-84de-4ba5-ac99-9bc42a65c9a5 2024-09-24 Warnings Exact identifier application number: M032 VERB PRODUCTS Balance Relief Salicylic Acid Dandruff Clinical Strength SALICYLIC ACID Verb Products Inc. 18bddd16-e001-445c-9647-801defc1d527 2024-09-03 Warnings Exact identifier application number: M032 Denorex Severe Itch COAL TAR Neoteric Cosmetics, Inc. 213ccbc4-2f52-58b6-e063-6294a90ae248 2024-09-03 Warnings Exact identifier application number: M032 SORARESAL SALICYLIC ACID Summer Herbal Inc. af734362-057b-4011-bf4e-c4e4dd67f68c 2024-09-03 Warnings Exact identifier application number: M032 ion 2 in 1 anti-dandruff Anti-dandruff PYRITHIONE ZINC Arcadia Beauty Labs LLC 38631b45-b222-4a25-8180-25970dabdffc 2024-08-28 Warnings Exact identifier application number: M032 TopCare Therapeutic Anti-Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Topco Associates LLC 070a5249-0b37-4b7f-a55b-609a0d8504d2 2024-08-22 Warnings Exact identifier application number: M032 J1003005 Jason Dandruff Relief SULFUR, SALICYLIC ACID The Hain Celestial Group, Inc. 625e8306-78c4-3317-e053-2991aa0afe81 2024-07-31 Warnings Exact identifier application number: M032 Jason Dandruff Relief Treatment 2 in 1 ZINC PYRITHIONE The Hain Celestial Group, Inc 4afa1048-7a76-4562-8dcf-9252d5bfa48a 2024-07-31 Warnings Exact identifier application number: M032 Alba Natural Acnedote Astringent SALICYLIC ACID The Hain Celestial Group, Inc. 939f90e7-e1de-4ca3-a484-90f1b87797d6 2024-07-31 Warnings Exact identifier application number: M032 Matrix Biolage ScalpSync Antidandruff PYRITHIONE ZINC L'Oreal USA Products Inc 8564f2cf-b680-4e2c-8451-f345c9852c1a 2024-07-18 Warnings Exact identifier application number: M032 Pete and Pedro Control Anti Itch Dandruff COAL TAR PETE AND PEDRO LLC 34ec83c1-31b9-4ecc-8bd2-898fd85364ba 2024-07-02 Warnings Exact identifier application number: M032 VICHY LABORATOIRES DERCOS Selenium Sulfide Anti-Dandruff SELENIUM SULFIDE, MICRONIZED L'Oreal USA Products Inc deae26e0-53f0-442b-959c-0f925a102db0 2024-06-25 Warnings Exact identifier application number: M032 VICHY LABORATOIRES Dercos Selenium Sulfide Anti-dandruff SELENIUM SULFIDE, MICRONIZED PRODUCTOS CAPILARES L'OREAL SA 3fcb03fc-552a-4b02-981e-2ff84142da96 2024-06-25 Warnings Exact identifier application number: M032 Dercos Salicylic Acid Anti-Dandruff Serum SALICYLIC ACID PRODUCTOS CAPILARES L'OREAL SA 024f9299-ee6c-48e3-89e7-96b7db060c30 2024-06-20 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