Thera Plus Pain Relief Cleansing

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Thera Plus Pain Relief Cleansing
Generic name: BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Manufacturer: Fourstar Group USA, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 513a620e-f69a-488d-8abc-36e2efccdc13
SPL ID: 2f86d0c4-2bca-74f7-e063-6394a90a8f0b
Version: 2
Effective date: 2025-03-04
Source export date: 2026-10-27
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/6f51a1483736359ffd78ed7be27289bc51f2a8463b934465bee40efbdef4dfd7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:07:13

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Thera Plus Pain Relief Cleansing	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Fourstar Group USA, Inc.	openfda.manufacturer_name
ndc	package	80684-150-00	openfda.package_ndc
ndc	product	80684-150	openfda.product_ndc
ndc11	package	80684015000	derived:openfda.package_ndc
rxcui		2047877	openfda.rxcui
spl id		2f86d0c4-2bca-74f7-e063-6394a90a8f0b	id
spl set id		513a620e-f69a-488d-8abc-36e2efccdc13	set_id
unii		F5UM2KM3W7	openfda.unii
unii		V13007Z41A	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. When using this product do not use in or near the eyes do not apply over large areas of the body or in large quantities do not apply over raw surfaces or blistered areas do not use longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition worsens, or symptoms persists for more than 7 days or clear up and then occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.