Antiseptic

Product NDC: 61010-5300
11-digit product format: 610105300
Labeler code: 61010
Product ID: 61010-5300_10d37ff3-97c6-9f55-e063-6294a90a656b
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride, benzocaine
Dosage form: SPRAY
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-15
Substance: BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength: 1; 50 mg/g; mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Antiseptic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	1 mg/g
BENZOCAINE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1245229	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
458e65f2-826d-4550-8c7d-17add2d7ba9a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61010-5300-0	2024-02-13	61010-5300, Cut and Scrape Antiseptic
61010-5300-2	2024-02-13	61010-5300, Cut and Scrape Antiseptic
61010-5300-0	2024-01-30	61010-5300, Cut and Scrape Antiseptic
61010-5300-2	2024-01-30	61010-5300, Cut and Scrape Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-5300-0	Antiseptic	60 g in 1 BOTTLE, SPRAY	SPRAY	60		4
61010-5300-2	Antiseptic	90 g in 1 BOTTLE, SPRAY	SPRAY	90		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
benzalkonium chloride	ACTIVE INGREDIENT	F5UM2KM3W7	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2
benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2
benzalkonium	ACTIVE MOIETY	7N6JUD5X6Y	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2
benzocaine	ACTIVE MOIETY	U3RSY48JW5	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-5300	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [SAFETEC OF AMERICA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240214_458e65f2-826d-4550-8c7d-17add2d7ba9a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DK12 Shower Gel Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e4ff0e-ef63-ef3b-e063-6294a90aa2b8	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Vitamin E Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe9270c0-bf6b-f0ff-e053-6394a90ae8f1	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2e51b-212b-368e-e063-6294a90a871c	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Fresh Energy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe80635d-9594-abf3-e053-6394a90aa78b	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Shower Gel Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e36111-ed4e-12de-e063-6294a90af639	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Creamy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe7fde7e-82fc-c13f-e053-6394a90aff68	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Oatmeal Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe16387b-1b16-1f41-e053-6294a90ae2c0	2024-12-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Isopropyl Alcohol Pad	ISOPROPYL ALCOHOL	Fourstar Group USA, Inc.	27edf5dc-3e68-bdd0-e063-6394a90ac485	2024-11-27	Warnings	Exact identifier application number: M003
MicroKlenz Antimicrobial	BENZETHONIUM CHLORIDE	Medline Industries, LP	115dda08-709c-490a-9693-419b51441960	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ALCOHOL PAD	Acme United Corporation	55421010-d806-4ca4-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Hydrogen Peroxide 3%	HYDROGEN PEROXIDE	Acme United Corporationn	f1db8929-9b95-0d6e-e053-2995a90a817f	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	d71047f6-1353-c758-e053-2995a90a962c	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ISOPROPYL ALCOHOL	Acme United Coporation	a01fec1b-1339-40b9-e053-2995a90aeda5	2024-11-23	Warnings	Exact identifier application number: M003
Med-Nap Sterile Alcohol Prep Pads	ISOPROPYL ALCOHOL	Acme United Corporation	c6eff57b-d537-69c8-e053-2a95a90adc3a	2024-11-23	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic	ISOPROPYL ALCOHOL	Acme United Corporation	a810e723-ad0c-8c71-e053-2995a90a0acc	2024-11-23	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0dcc9bd2-aea5-4c27-9956-47d56221726b	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	9a9d42ad-79d5-4acc-b5d9-cb7468961d47	2024-11-22	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	044a6287-f568-4cfa-a813-7fc0e6ffc352	2024-11-22	Warnings	Exact identifier application number: M003
NEXXGEN 70% RUBBING ALCOHOL	ISOPROPYL ALCOHOL	A & A Nexxgen LLC	ce73ac48-c5af-4a35-950c-62ff0232aa30	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8	2024-11-22	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1245229	benzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray	PSN	458e65f2-826d-4550-8c7d-17add2d7ba9a	4
1245229	benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray	SCD	458e65f2-826d-4550-8c7d-17add2d7ba9a	4
1245229	benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray	SY	458e65f2-826d-4550-8c7d-17add2d7ba9a	4
1245229	benzalkonium chloride 0.1 % / benzocaine 5 % Topical Spray	PSN	35d06b38-55dd-e306-e063-6394a90aaf26	1
1245229	benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray	SCD	35d06b38-55dd-e306-e063-6394a90aaf26	1
1245229	benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray	SY	35d06b38-55dd-e306-e063-6394a90aaf26	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-5300-0	61010530000	60 g in 1 BOTTLE, SPRAY (61010-5300-0)	60 g	2012-02-15	0000-00-00	No	No	Current
61010-5300-2	61010530002	90 g in 1 BOTTLE, SPRAY (61010-5300-2)	90 g	2012-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Only Antiseptic First Aid Spray	Acme United Corporation	2025-05-23	HUMAN OTC DRUG LABEL	1
61010-5300, Cut and Scrape Antiseptic	Safetec of America, Inc.	2024-02-07	HUMAN OTC DRUG LABEL	4