Home NDC 0904-5259 Thera-Gel
Product NDC 0904-5259
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 30 of 32 · 630 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Green Apple 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. ab3658d1-74c7-45ee-b7ac-a6065c46146b 2023-12-15 Warnings Exact identifier application number: M032 Equate Dry Scalp 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 508567b7-7228-4d4e-ac7e-7a6b7419ab2c 2023-12-15 Warnings Exact identifier application number: M032 Equate Everyday Clean 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 593385c4-a710-44c7-a810-f001f5fbf257 2023-12-15 Warnings Exact identifier application number: M032 Equate Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 7d9f8b53-531e-42f8-8840-8a9d63734c71 2023-12-14 Warnings Exact identifier application number: M032 Equate Everyday Clean Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 3064a5f4-0dd1-4f61-953d-9d71388b4d7a 2023-12-14 Warnings Exact identifier application number: M032 Equate Dry Scalp 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 006945c2-12a2-431e-8f59-0a1e57e2646f 2023-12-14 Warnings Exact identifier application number: M032 Equate Everyday Clean 2 in 1 Dandruff Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. 8c8990bd-690f-4f09-a23c-ebfa788c4319 2023-12-12 Warnings Exact identifier application number: M032 Mizani Scalp Care Conditioner Antidandruff Conditioner PYRITHIONE ZINC L'Oreal USA Products Inc d337e40d-a066-4bab-8da8-b53fca29962f 2023-12-11 Warnings Exact identifier application number: M032 Redken 5th Avenue NYC Scalp Relief Dandruff Control PYRITHIONE ZINC L'Oreal USA Products Inc 306a1ef4-e7ed-4c8c-877c-3c34d3e6d7b7 2023-12-11 Warnings Exact identifier application number: M032 LOreal Paris Ever Pure Dandruff Scalp Care and Detox PYRITHIONE ZINC L'Oreal USA Products Inc bd281704-b411-4802-8dc6-8700d73fec9f 2023-12-11 Warnings Exact identifier application number: M032 Mizani Scalp Care Antidandruff PYRITHIONE ZINC L'Oreal USA Products Inc 482e11db-c886-4ad3-b378-0839a0715ea7 2023-12-11 Warnings Exact identifier application number: M032 Dr. Sheffield Psoriasis Medicated Moisturizer PSORIASIS MEDICATED MOISTURIZER Sheffield Pharmaceuticals LLC 03739345-2ed2-4157-89e7-48926721815b 2023-11-28 Warnings Exact identifier application number: M032 CONTROL Dandruff- Free Beard Wash PYRITHIONE ZINC Kamedis Inc d9f58a4d-d53a-4965-ac5c-67c2ce4947ee 2023-11-27 Warnings Exact identifier application number: M032 Equate Therapeutic Dandruff Extra Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. e1785351-518c-4688-a3ea-61a0d42139a0 2023-11-21 Warnings Exact identifier application number: M032 111MedCo Medicated Bar 2 Pyrithione Zinc PYRITHIONE ZINC 111MedCo LLC 22e0c6f9-8884-4869-b13f-fc4976da58da 2023-11-20 Warnings Exact identifier application number: M032 Equate Therapeutic Dandruff Original Strength Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR Wal-Mart Stores, Inc. 78cabb38-9f9d-403d-b79c-ceedcea1812f 2023-11-20 Warnings Exact identifier application number: M032 Aloe Coal 01 PYRITHIONE ZINC T. SPRUILL, LLC 40a94657-6722-46b1-87ed-a15bf60ffc7a 2023-11-11 Warnings Exact identifier application number: M032 HAIRCARE Physicians Recommended SALICYLIC ACID LAWRENCE E SAMUELS MD INC 095fcc1c-8f5b-47bd-a32a-7f5da5d162cd 2023-11-11 Warnings Exact identifier application number: M032 Home Health Psoriasis Medicated Scalp and Body Wash SALICYLIC ACID Home Health d10dad0e-34e1-49d4-a17a-36dbdbd66eb6 2023-11-06 Warnings Exact identifier application number: M032 Glovers Therapeutic Care SALICYLIC ACID J. Strickland and Co. bf101147-1408-4819-829a-6079f6448300 2023-11-05 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