CHLORHEXIDINE GLUCONATE

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: CHLORHEXIDINE GLUCONATE
Generic name: CHLORHEXIDINE GLUCONATE
Manufacturer: Sage Products LLC
Product type: HUMAN OTC DRUG
SPL set ID: bdb6a012-37e5-4664-84a3-134bea284744
SPL ID: 54620ea3-da65-c5d7-e063-6394a90ad14a
Version: 22
Effective date: 2026-06-16
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:47:44

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	021669	derived:openfda.application_number
application number		NDA021669	openfda.application_number
brand name		CHLORHEXIDINE GLUCONATE	openfda.brand_name
generic name		CHLORHEXIDINE GLUCONATE	openfda.generic_name
manufacturer name		Sage Products LLC	openfda.manufacturer_name
ndc	package	53462-705-26	openfda.package_ndc
ndc	package	53462-705-23	openfda.package_ndc
ndc	package	53462-705-20	openfda.package_ndc
ndc	product	53462-705	openfda.product_ndc
ndc11	package	53462070520	derived:openfda.package_ndc
ndc11	package	53462070523	derived:openfda.package_ndc
ndc11	package	53462070526	derived:openfda.package_ndc
rxcui		846127	openfda.rxcui
spl id		54620ea3-da65-c5d7-e063-6394a90ad14a	id
spl set id		bdb6a012-37e5-4664-84a3-134bea284744	set_id
unii		MOR84MUD8E	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 Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients allergic to chlorhexidine gluconate or any other ingredient in this product for lumbar punctures or in contact with the meninges on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears and mouth. May cause serious or permanent injury if chlorhexidine is permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Reported adverse events (FAERS/openFDA)#

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