Antiseptic

Product NDC: 84269-3501
11-digit product format: 842693501
Labeler code: 84269
Product ID: 84269-3501_544f5843-189c-a04b-e063-6294a90a9b78
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride, benzocaine
Dosage form: SPRAY
Route: TOPICAL
Labeler: Wildman Business Group
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-01
Substance: BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength: 50; 1 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
BENZOCAINE	50 mg/g
BENZALKONIUM CHLORIDE	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup
F5UM2KM3W7	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
1fd15b91-6b81-d0bd-e063-6294a90a4d27	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84269-3501-1	Antiseptic	60 g in 1 BOTTLE, SPRAY	SPRAY	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84269-3501	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [WILDMAN BUSINESS GROUP]	1	Current NDC, 1 package rows	20240901_1fd15b91-6b81-d0bd-e063-6294a90a4d27.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 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Instant Hand Antiseptic	ALCOHOL	ASP Global	291eaa18-81f8-6907-e054-00144ff88e88	2024-12-03	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Passion Berrys	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	aee5d7c2-93b3-f55e-e053-2995a90af72e	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Fresh and Relax	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d3086-7902-2837-e053-2995a90a39df	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Grapefruit	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f49-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Antibacterial Red Fruits	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	b04d4c11-1f4d-06c4-e053-2995a90a1e48	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Oatmeal	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e1c5f6-195c-16d6-e063-6394a90abb86	2024-12-02	Warnings	Exact identifier application number: M003
Aquabain Instant Hand Sanitizer	ETHYL ALCOHOL 70%	Industria La Popular, S.A.	b2e4d58d-adff-3cb2-e053-2995a90a392e	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Liquid Hand Fresh Energy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2289d-60f4-260c-e063-6394a90a96f6	2024-12-02	Warnings	Exact identifier application number: M003
Jabonito Kids Green Apple Liquid	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	021bc525-3ebe-efc2-e063-6394a90a3fe3	2024-12-02	Warnings	Exact identifier application number: M003
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

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

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	1fd15b91-6b81-d0bd-e063-6294a90a4d27	1
1245229	benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray	SCD	1fd15b91-6b81-d0bd-e063-6294a90a4d27	1
1245229	benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray	SY	1fd15b91-6b81-d0bd-e063-6294a90a4d27	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84269-3501-1	84269350101	60 g in 1 BOTTLE, SPRAY	60 g				Historical
84269-3501-2	84269350102	60 g in 1 BOTTLE, SPRAY (84269-3501-2)	60 g	2026-03-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
84269-3501, Cut and Scrape Antiseptic	Wildman Business Group \| Safetec of America Inc \| Safetec of America, Inc.	2026-06-15	HUMAN OTC DRUG LABEL	2