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 27 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID TAI GUK PHARM. CO., LTD 1e572a86-9115-4597-e063-6394a90a484e 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID TAI GUK PHARM. CO., LTD 1e572a97-1a38-8360-e063-6394a90a47a3 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID LG H&H CO., LTD. 1e584724-7059-38ab-e063-6394a90aceb7 2024-05-31 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID LG H&H CO., LTD. 1e584724-705a-38ab-e063-6394a90aceb7 2024-05-31 Warnings Exact identifier application number: M032 Thera-Gel COAL TAR Major Pharmaceuticals 1c18fde9-d39b-4339-8f62-3f352d450291 2024-05-28 Warnings Exact identifier application number: M032 upandup Anti-dandruff with Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID TARGET CORPORATION 482332f8-0db4-4ec7-81e9-c4efbba16a26 2024-05-20 Warnings Exact identifier application number: M032 True Plus Real Therapeutic T PLUS EXTRA STRENGTH COAL TAR TAR DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Garcoa, Inc. 20116e1e-56f1-4018-99ef-758de7fc2464 2024-05-10 Warnings Exact identifier application number: M032 up and up Moisturizing Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION e315b2d8-304d-4807-9594-9286e9b642ef 2024-05-10 Warnings Exact identifier application number: M032 amazon basics therapeutic tar gel anti-dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR AMAZON.COM SERVICES LLC 0464b4ff-1be1-4d84-b7fd-b771ebc1e16c 2024-05-09 Warnings Exact identifier application number: M032 Walgreens Clinical Strength Medicated Dandruff Anti-dandruff, Anti-seborrheic dermatitis SELENIUM SULFIDE Walgreen Company cc83427d-49e6-4a20-9d03-9ec8ce27e487 2024-05-09 Warnings Exact identifier application number: M032 meijer MEDICATED selenium sulfide Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Meijer Distribution, Inc c8dee061-3362-400f-aa59-93ec0b8125ba 2024-05-01 Warnings Exact identifier application number: M032 Walgreens Dandruff With Menthol/Selenium Sulfide Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE Walgreen Company 70c7b400-a295-4b99-8673-e6a38343d76f 2024-05-01 Warnings Exact identifier application number: M032 up and up Medicated Anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SELENIUM SULFIDE TARGET CORPORATION a516282f-ed6b-4e94-b269-ea34f700dd69 2024-04-25 Warnings Exact identifier application number: M032 Walgreens Tplus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID Walgreen Company 339d390e-0b09-4c42-af1f-9465daa9f7c9 2024-04-22 Warnings Exact identifier application number: M032 Walgreens Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Walgreen Company 930d92a9-d0bc-42e1-873e-5c27e93a39b5 2024-04-22 Warnings Exact identifier application number: M032 Rugby Anti-Dandruff SELENIUM SULFIDE Rugby Laboratories f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2 2024-03-14 Warnings Exact identifier application number: M032 Leader Medicated Dandruff Anti-Seborrheic Dermatitis, Anti-Dandruff SELENIUM SULFIDE Cardinal Health, 110 dba LEADER 3f64a2ef-a415-49b0-bf14-eb4da66d511f 2024-03-13 Warnings Exact identifier application number: M032 Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis SALICYLIC ACID Cardinal Health, 110 dba LEADER 509434a9-50c4-4337-8e5b-17bdc667d23b 2024-03-13 Warnings Exact identifier application number: M032 meijer therapeutic t plus plus tar gel dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Meijer Distribution, Inc f7cce683-6e1f-4214-a38b-37eb046b7f4d 2024-03-05 Warnings Exact identifier application number: M032 Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasis SALICYLIC ACID, SULFUR Rugby Laboratories aec81d61-1d28-490f-9654-f66bd4a30ffa 2024-03-01 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