Home NDC 0904-5259-44 Thera-Gel
Product NDC 0904-5259
Requested package NDC 0904-5259-44
11-digit product format 009045259
Labeler code 0904
Product ID 0904-5259_0ee62461-8b30-435e-8069-8947df75f89a
Type HUMAN OTC DRUG
Nonproprietary name Coal Tar
Dosage form SHAMPOO
Route TOPICAL
Labeler Major Pharmaceuticals
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-05-18
Substance COAL TAR
Active strength 5 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Thera-Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COAL TAR 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R533ESO2EC Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309381 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-5259-44 Thera-Gel 251 mL in 1 BOTTLE, PLASTIC SHAMPOO 251 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5259 MAJOR THERA-GEL THERAPEUTIC ANTI-DANDRUFF (COAL TAR) SHAMPOO [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 1 package rows 20240531_1c18fde9-d39b-4339-8f62-3f352d450291.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 23 of 31 · 615 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dermaharmony Face and Body PYRITHIONE ZINC D3 Development, Inc. bd72b53c-b22c-40d0-e053-2995a90af9c1 2024-12-20 Warnings Exact identifier application number: M032 Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. 637851c6-ff4a-8bbc-e053-2991aa0a963c 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. cb442483-b735-01a0-e053-2995a90aaff5 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Pyrithione Zinc with Shea Butter PYRITHIONE ZINC D3 Development, Inc. dc7ba02c-bdbd-5136-e053-2995a90ac545 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Tea Tree Bar PYRITHIONE ZINC D3 Development, Inc. e9d5eb14-1840-ae21-e053-2a95a90aa321 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Unscented Bar PYRITHIONE ZINC D3 Development, Inc. e9d66c9c-5fb1-0a90-e053-2a95a90ab7a4 2024-12-20 Warnings Exact identifier application number: M032 BYE-BYE CRADLE CAP PYRITHIONE ZINC Tubby Todd f4398ad2-7da5-aff0-e053-2995a90ae266 2024-12-12 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF PYRITHIONE ZINC Davines S.p.A. 1f7e0265-0543-4ef9-addf-4d514d0eedfe 2024-12-11 Warnings Exact identifier application number: M032 NATURALTECH PURIFYING ANTI-DANDRUFF SELENIUM SULFIDE Davines S.p.A. 369a24fd-3882-4fad-b57a-45806090aff1 2024-12-11 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs b5ea8f33-8f18-7464-e053-2a95a90a39b2 2024-12-09 Warnings Exact identifier application number: M032 Skin Renewing Cream SALICYLIC ACID Allure Labs fa54cf42-3ba7-b7b3-e053-6394a90aa7a0 2024-12-09 Warnings Exact identifier application number: M032 Satinique Anti Dandruff Scalp and Hair SALICYLIC ACID Access Business Group LLC 03252c61-c51b-4e87-a06d-a61b8393704f 2024-12-09 Warnings Exact identifier application number: M032 Dry Skin Relief Bar SALICYLIC ACID CP Skin Health Group, Inc. eceb73b0-4c2f-4989-a3aa-a6553bc68252 2024-12-09 Warnings Exact identifier application number: M032 Head and Shoulders Dual Pack Green Apple PYRITHIONE ZINC The Procter & Gamble Manufacturing Company c8208bac-9d32-7694-e053-2a95a90a746c 2024-11-27 Warnings Exact identifier application number: M032 Vanicream PYRITHIONE ZINC Pharmaceutical Specialties, Inc. d124a093-f739-0666-e053-2995a90a52ed 2024-11-27 Warnings Exact identifier application number: M032 LEAHUE MADHUCA TONIC SALICYLIC ACID Bio-interchange Co. 81454c8a-ddcf-7cef-e053-2991aa0a53c2 2024-11-27 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Oily, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. b09c3b0d-564e-45e4-b6ff-c1f0c12a9521 2024-11-13 Warnings Exact identifier application number: M032 Hairitage Wash It Away Anti-Dandruff for Dry, Flaky Scalp SELENIUM SULFIDE Maesa, LLC. fa5d4ee3-fbeb-4379-bbd3-2b5b2cc45430 2024-11-12 Warnings Exact identifier application number: M032 Marcs 2 in 1 Everyday Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. 1daaa2c9-fbc7-4aa5-9772-e15710932066 2024-11-11 Warnings Exact identifier application number: M032 Marcs Dry Scalp Care Dandruff Anti-Dandruff PYRITHIONE ZINC Mark Glassman, Inc. ffab6ca6-7c8f-4080-836c-635a6ba3c0bb 2024-11-11 Warnings Exact identifier application number: M032
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-5259-44 00904525944 251 mL in 1 BOTTLE, PLASTIC (0904-5259-44) 251 ml 2010-05-18 0000-00-00 No No Current