Antiseptic

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: Antiseptic
Generic name: CETYLPYRIDINIUM CHLORIDE
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 857e8bc4-125f-4796-ac10-6880702816fe
SPL ID: 4ab84f55-b795-e80b-e063-6394a90a927a
Version: 15
Effective date: 2026-02-13
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:04

Harmonized routes table
Harmonized routes
ORAL

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		505G(a)(3)	openfda.application_number
brand name		Antiseptic	openfda.brand_name
generic name		CETYLPYRIDINIUM CHLORIDE	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-299-86	openfda.package_ndc
ndc	package	36800-299-21	openfda.package_ndc
ndc	product	36800-299	openfda.product_ndc
ndc11	package	36800029986	derived:openfda.package_ndc
ndc11	package	36800029921	derived:openfda.package_ndc
rxcui		1100924	openfda.rxcui
spl id		4ab84f55-b795-e80b-e063-6394a90a927a	id
spl set id		857e8bc4-125f-4796-ac10-6880702816fe	set_id
unii		D9OM4SK49P	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 this product Stop use and ask a dentist if gingivitis, bleeding or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTION DISTRIBUTED BY TOPCO ASSOCIATES, LLC, ITASCA, IL 60143 ©TOPCO VIJA0125 QUESTIONS? 1-888-423-0139 topcare@topcare.com www.topcarebrand.com Scan here for more information or call 1-888-423-0139 QUALITY GUARANTEED

Reported adverse events (FAERS/openFDA)#

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