Home NDC 78663-201 THERABLAST
Product NDC 78663-201
11-digit product format 786630201
Labeler code 78663
Product ID 78663-201_2b3a9786-358b-6c49-e063-6294a90a5d93
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE, MENTHOL
Dosage form LOTION
Route TOPICAL
Labeler Releaf Technologies LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-06
Substance LIDOCAINE; MENTHOL
Active strength 4; 1 g/100mL; g/100mL
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 THERABLAST
Brand name suffix MAXIMUM RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE 4 g/100mL MENTHOL 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup L7T10EIP3A Internal UNII 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 78663-201-34 THERABLASTMAXIMUM RELIEF 100 mL in 1 TUBE LOTION 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78663-201 THERABLAST MAXIMUM RELIEF (LIDOCAINE, MENTHOL) LOTION [RELEAF TECHNOLOGIES LLC] 2 Current NDC, 1 package rows 20250110_09809985-3a88-9bb7-e063-6394a90a2f5f.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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78663-201-34 78663020134 100 mL in 1 TUBE (78663-201-34) 100 ml 2023-11-06 No No Current