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 16 of 32 · 630 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PS-2896 Hydrocortisone Cream 1%, 0.9g PS-2896 HYDROCORTISONE CREAM 1%, 0.9G ProStat First Aid LLC 0074e7bf-8c62-a5a7-e063-6394a90a63fc 2025-12-15 Warnings Exact identifier application number: M032 Hydrocortisone 1% HYDROCORTISONE 1% ProStat First Aid LLC f707bda4-074a-6406-e053-6394a90a7ae1 2025-12-15 Warnings Exact identifier application number: M032 Hydrocortisone Cream 1% HYDROCORTISONE CREAM 1% Front Line Safety 0f4ede34-7e70-789e-e063-6394a90a72a4 2025-12-15 Warnings Exact identifier application number: M032 Head and Shoulders Deep Moisture Hair and Scalp Conditioner PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 58ecdd38-1f23-ee32-e053-2991aa0afe81 2025-12-15 Warnings Exact identifier application number: M032 Head and Shoulders Deep Moisture PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 5e2133c2-032d-4c16-e053-2991aa0ac61b 2025-12-15 Warnings Exact identifier application number: M032 Dermgentle Seborrheic Face Cream PYRITHIONE ZINC Dermgentle LLC 45232668-6953-80a0-e063-6294a90a6e4b 2025-12-12 Warnings Exact identifier application number: M032 Kadason Medicated SALICYLIC ACID Ys Pharma Inc. f425408c-95b1-409f-b64f-2e9f2f3310a0 2025-12-10 Warnings Exact identifier application number: M032 Zinc Pyrithione ZINC PYRITHIONE Harry's Inc. a6fdb13b-7943-3ae9-e053-2995a90a9db5 2025-12-08 Warnings Exact identifier application number: M032 Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruff PYRITHIONE ZINC FAMILY DOLLAR SERVICES INC bf7b2339-20a4-4bab-b82f-6e28ff5187cb 2025-12-08 Warnings Exact identifier application number: M032 therapeutic tar anti-dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis COAL TAR GOODSENSE 72ab0e6b-72a5-4e8a-af44-963251b0641f 2025-12-08 Warnings Exact identifier application number: M032 Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC FAMILY DOLLAR SERVICES INC 5ccd409b-a81f-41bc-b986-bc7c0cc643fd 2025-12-08 Warnings Exact identifier application number: M032 Gold Bond Psoriasis Relief Medicated Multi-Symptom SALICYLIC ACID Gold Bond Co LLC 5949a2e4-9169-4fca-aabb-b18dd1bc298b 2025-12-04 Warnings Exact identifier application number: M032 Medicasp Anti-Dandruff COAL TAR Genomma Lab USA 07bc9cab-4215-4bc0-9104-e6cf85d74b68 2025-12-04 Warnings Exact identifier application number: M032 Dermaharmony Sulfur and Salicylic Acid SALICYLIC ACID, SULFUR D3 Development, Inc. 8cb1d526-1ba7-6b02-e053-2a95a90aa1d0 2025-12-02 Warnings Exact identifier application number: M032 Zinc Therapy PYRITHIONE ZINC D3 Development, Inc. 6b2de5ba-ad4b-5d43-e053-2991aa0ac3b2 2025-12-02 Warnings Exact identifier application number: M032 Dermaharmony 1% Pyrithione Zinc PYRITHIONE ZINC D3 Development, Inc. b9e765eb-f55f-f38a-e053-2a95a90aafd1 2025-12-02 Warnings Exact identifier application number: M032 CeraVe 2 in1 Anti Dandruff Hydrating Conditioner PYRITHIONE ZINC L'Oreal USA Products Inc 8a7b4626-d76b-45c4-b7a3-33c91e9a0bfe 2025-12-02 Warnings Exact identifier application number: M032 Head and Shoulders Apple Cider Vinegar PYRITHIONE ZINC The Procter & Gamble Manufacturing Company b6984dab-e3da-3f36-e053-2995a90a2c0e 2025-12-01 Warnings Exact identifier application number: M032 DHS TAR COAL TAR Person and Covey 4d088ad5-1f89-48fe-ac8a-12cb62847b38 2025-11-28 Warnings Exact identifier application number: M032 DHS SAL 4 oz. DHS SAL Person and Covey 62e13b0d-2455-46c2-bff3-1aa88b092327 2025-11-28 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