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 23 of 32 · 630 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Equate Soft and Smooth 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. c759b347-bdfb-4ff5-a464-b40fa2efb843 2025-01-10 Warnings Exact identifier application number: M032 Equate Mens Bold Scent 2 in 1 Dandruff SH and COND Anti-Dandruff PYRITHIONE ZINC Wal-Mart Stores, Inc. d561e8d2-2761-422b-8f05-ac76d3a043eb 2025-01-10 Warnings Exact identifier application number: M032 Royal Oils by Head and Shoulders Sulfate Free Scalp Care PYRITHIONE ZINC The Procter & Gamble Manufacturing Company d73ab807-027f-7581-e053-2995a90ada83 2025-01-08 Warnings Exact identifier application number: M032 Head and Shoulders Supreme Color Protect Conditioner PYRITHIONE ZINC The Procter & Gamble Manufacturing Company 86ac3037-9ff2-25ea-e053-2a91aa0a43e3 2025-01-08 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC e5702ac7-e680-ab4b-e053-2995a90ad442 2025-01-01 Warnings Exact identifier application number: M032 Oribe Serene Scalp Anti Dandruff ORIBE SERENE SCALP ANTI DANDRUFF Oribe Hair Care LLC abaf1c64-1c4d-481a-9872-b64fcf82cc63 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bdad4d-d499-70a9-e053-2a95a90a5cd9 2025-01-01 Warnings Exact identifier application number: M032 Dr. Groot Anti-dandruff Scalp Care 2 in 1 SALICYLIC ACID TAI GUK PHARM. CO., LTD e8bf3852-e963-7a48-e053-2995a90a5aa1 2025-01-01 Warnings Exact identifier application number: M032 American Crew PYRITHIONE ZINC Revlon Consumer Products Corp 9566b567-90be-4803-b940-e6a91750778f 2024-12-30 Warnings Exact identifier application number: M032 Kerastase Paris K Symbiose Serum Nuit Antipelliculaire Intensif Antidandruff Treatment SALICYLIC ACID L'Oreal USA Products Inc. d72688ed-d153-4eed-988f-5386eb68559d 2024-12-30 Warnings Exact identifier application number: M032 Dermaharmony Seborrheic Dermatitis PYRITHIONE ZINC D3 Development, Inc. 8d81521d-9e6f-1acf-e053-2995a90a9242 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Sulfur and Salicylic Acid SALICYLIC ACID, SULFUR D3 Development, Inc. a1c61da2-7e7a-430a-e053-2995a90ad594 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint SALICYLIC ACID, SULFUR D3 Development, Inc. af7060a9-986c-500e-e053-2a95a90a6438 2024-12-20 Warnings Exact identifier application number: M032 Dermaharmony Bar Peppermint PYRITHIONE ZINC D3 Development, Inc. a19b74b0-88c6-6897-e053-2a95a90a7309 2024-12-20 Warnings Exact identifier application number: M032 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
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