thera plus pain relief cleansing

Generic: benzalkonium chloride, lidocaine hydrochloride

Labeler: fourstar group usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus pain relief cleansing
Generic Name benzalkonium chloride, lidocaine hydrochloride
Labeler fourstar group usa, inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzalkonium chloride 1.3 mg/mL, lidocaine hydrochloride 40 mg/mL

Manufacturer
Fourstar Group USA, Inc.

Identifiers & Regulatory

Product NDC 80684-150
Product ID 80684-150_2f86d0c4-2bca-74f7-e063-6394a90a8f0b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M003
Listing Expiration 2026-12-31
Marketing Start 2025-03-03

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] antiarrhythmic [epc] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80684150
Hyphenated Format 80684-150

Supplemental Identifiers

RxCUI
2047877
UPC
0049696121606
UNII
F5UM2KM3W7 V13007Z41A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name thera plus pain relief cleansing (source: ndc)
Generic Name benzalkonium chloride, lidocaine hydrochloride (source: ndc)
Application Number M003 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.3 mg/mL
  • 40 mg/mL
source: ndc
Packaging
  • 148 mL in 1 BOTTLE (80684-150-00)
source: ndc

Packages (1)

Ingredients (2)

benzalkonium chloride (1.3 mg/mL) lidocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "2f86d0c4-2bca-74f7-e063-6394a90a8f0b", "openfda": {"upc": ["0049696121606"], "unii": ["F5UM2KM3W7", "V13007Z41A"], "rxcui": ["2047877"], "spl_set_id": ["513a620e-f69a-488d-8abc-36e2efccdc13"], "manufacturer_name": ["Fourstar Group USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "148 mL in 1 BOTTLE (80684-150-00)", "package_ndc": "80684-150-00", "marketing_start_date": "20250303"}], "brand_name": "Thera Plus Pain Relief Cleansing", "product_id": "80684-150_2f86d0c4-2bca-74f7-e063-6394a90a8f0b", "dosage_form": "LIQUID", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Antiarrhythmic [EPC]", "Local Anesthesia [PE]"], "product_ndc": "80684-150", "generic_name": "BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE", "labeler_name": "Fourstar Group USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera Plus Pain Relief Cleansing", "active_ingredients": [{"name": "BENZALKONIUM CHLORIDE", "strength": "1.3 mg/mL"}, {"name": "LIDOCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "M003", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250303", "listing_expiration_date": "20261231"}