Home NDC 80684-150 Thera Plus Pain Relief Cleansing
Product NDC 80684-150
11-digit product format 806840150
Labeler code 80684
Product ID 80684-150_2f86d0c4-2bca-74f7-e063-6394a90a8f0b
Type HUMAN OTC DRUG
Nonproprietary name BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form LIQUID
Route TOPICAL
Labeler Fourstar Group USA, Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-03
Substance BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength 1.3; 40 mg/mL; 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 Pain Relief Cleansing
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 1.3 mg/mL LIDOCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup 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 2047877 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 80684-150-00 Thera Plus Pain Relief Cleansing 148 mL in 1 BOTTLE LIQUID 148 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-150 THERA PLUS PAIN RELIEF CLEANSING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) LIQUID [FOURSTAR GROUP USA, INC.] 2 Current NDC, 1 package rows 20250306_513a620e-f69a-488d-8abc-36e2efccdc13.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 9 of 115 · 2,286 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 80684-150-00 80684015000 148 mL in 1 BOTTLE (80684-150-00) 148 ml 2025-03-03 No No Current