Guardian Vaginal

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: Guardian Vaginal
Generic name: BENZALKONIUM CHLORIDE
Manufacturer: Eastern Century Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 1605ba44-02b7-4c72-9fec-89a5aa962b44
SPL ID: 16e363c4-5db3-ef40-e063-6394a90a6941
Version: 11
Effective date: 2024-04-24
Source export date: 2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:35:39

Harmonized routes table
Harmonized routes
VAGINAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Guardian Vaginal	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE	openfda.generic_name
manufacturer name		Eastern Century Pharmaceuticals	openfda.manufacturer_name
ndc	package	68915-280-02	openfda.package_ndc
ndc	package	68915-280-01	openfda.package_ndc
ndc	product	68915-280	openfda.product_ndc
ndc11	package	68915028001	derived:openfda.package_ndc
ndc11	package	68915028002	derived:openfda.package_ndc
rxcui		1111013	openfda.rxcui
spl id		16e363c4-5db3-ef40-e063-6394a90a6941	id
spl set id		1605ba44-02b7-4c72-9fec-89a5aa962b44	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: Wash and douche with water. Do not Douche to prevent pregnancy. During pregnancy. If you have symptoms of pelvic inflammatory disease (PID) or a sexually transmitted disease (STD). To self-treat or prevent a STD or PID. After exposure to a STD Stop using this product stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate serious condition. If swallowed, get medical help or contact a Poison Control Center right away. External use only. Do not use in eyes. Stop use and ask a doctor if: Rash and irritation and redness develops. Discontinue use if any burning, itching, or irritation of the vagina occur during use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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