Home NDC 80684-098 Thera Plus Max Strength Lidocaine Pain Relief Liquid
Product NDC 80684-098
11-digit product format 806840098
Labeler code 80684
Product ID 80684-098_0b61e01d-3530-d2a1-e063-6294a90a513c
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Fourstar Group USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance LIDOCAINE HYDROCHLORIDE
Active strength 40 mg/mL
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 Thera Plus Max Strength Lidocaine Pain Relief Liquid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1987647 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 80684-098-00 Thera Plus Max Strength Lidocaine Pain Relief Liquid 74 mL in 1 BOTTLE LIQUID 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-098 THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID (LIDOCAINE HYDROCHLORIDE) LIQUID [FOURSTAR GROUP USA, INC.] 2 Current NDC, 1 package rows 20240201_0a228b06-0e1c-6c75-e063-6294a90a9a0e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80684-098-00 80684009800 74 mL in 1 BOTTLE (80684-098-00) 74 ml 2024-02-01 No No Current