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: BENZALKONIUM CHLORIDE, BENZOCAINE
Manufacturer: Safetec of America, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 458e65f2-826d-4550-8c7d-17add2d7ba9a
SPL ID: 10d37ff3-97c6-9f55-e063-6294a90a656b
Version: 4
Effective date: 2024-02-07
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 06:35:30

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M003	openfda.application_number
brand name		Antiseptic	openfda.brand_name
generic name		BENZALKONIUM CHLORIDE, BENZOCAINE	openfda.generic_name
manufacturer name		Safetec of America, Inc.	openfda.manufacturer_name
ndc	package	61010-5300-2	openfda.package_ndc
ndc	package	61010-5300-0	openfda.package_ndc
ndc	product	61010-5300	openfda.product_ndc
ndc11	package	61010530000	derived:openfda.package_ndc
ndc11	package	61010530002	derived:openfda.package_ndc
rxcui		1245229	openfda.rxcui
spl id		10d37ff3-97c6-9f55-e063-6294a90a656b	id
spl set id		458e65f2-826d-4550-8c7d-17add2d7ba9a	set_id
unii		U3RSY48JW5	openfda.unii
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. Flammable keep away from fire or flame. Do not use near eyes or mucous membranes on deep or puncture wounds, animal bites, or serious burns over large areas of the body more than one week unless directed by a doctor Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. Stop use and ask doctor if condition persists or gets worse

Reported adverse events (FAERS/openFDA)#

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