TRI-SOFT SOFTENING

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: TRI-SOFT SOFTENING
Generic name: BENZALKONIUM CHLORIDE
Manufacturer: Clinical Therapeutic Solutions
Product type: HUMAN OTC DRUG
SPL set ID: 3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb
SPL ID: 0973c7d8-bd6d-e83b-e063-6294a90acf55
Version: 4
Effective date: 2023-11-05
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:03:14

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		TRI-SOFT SOFTENING	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE	openfda.generic_name
manufacturer name		Clinical Therapeutic Solutions	openfda.manufacturer_name
ndc	package	44577-711-08	openfda.package_ndc
ndc	product	44577-711	openfda.product_ndc
ndc11	package	44577071108	derived:openfda.package_ndc
rxcui		1046593	openfda.rxcui
spl id		0973c7d8-bd6d-e83b-e063-6294a90acf55	id
spl set id		3d2bd5ab-5288-4d7d-b9e6-1b737a791bdb	set_id
unii		F5UM2KM3W7	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. Do not use in the eyes. If eye contact occurs, rinse thoroughly with water. Stop use and consult a physician if irritation or redness develops and persists for more than 72 hours. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.

Reported adverse events (FAERS/openFDA)#

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