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 31 of 32 · 630 matching rows.
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