Guardelle

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: Guardelle
Generic name: BENZALKONIUM CHLORIDE
Manufacturer: Social Medical Supply LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8793e3be-7409-4f71-9397-abbeacd27cf8
SPL ID: 3a8774ed-4fdf-48b6-a54b-8db85492cb34
Version: 1
Effective date: 2025-12-22
Source export date: 2026-10-30
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/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:59:12

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Guardelle	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE	openfda.generic_name
manufacturer name		Social Medical Supply LLC	openfda.manufacturer_name
ndc	package	85754-000-18	openfda.package_ndc
ndc	package	85754-000-07	openfda.package_ndc
ndc	package	85754-000-02	openfda.package_ndc
ndc	product	85754-000	openfda.product_ndc
ndc11	package	85754000007	derived:openfda.package_ndc
ndc11	package	85754000002	derived:openfda.package_ndc
ndc11	package	85754000018	derived:openfda.package_ndc
rxcui		1020365	openfda.rxcui
spl id		3a8774ed-4fdf-48b6-a54b-8db85492cb34	id
spl set id		8793e3be-7409-4f71-9397-abbeacd27cf8	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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if skin/eye irritation develops.

Reported adverse events (FAERS/openFDA)#

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