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 111 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DermaWound Wound Care	POVIDONE-IODINE	Progressive Doctors, LLC	2d49daa7-aa02-4219-880b-e1697bde8a7e	2023-12-15	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ALCOHOL	Humco Holding Group, Inc.	829f3e16-7a9b-4da7-87d2-f58254bda721	2023-12-15	Warnings	Exact identifier application number: M003
Humco Iodides Tincture	ETHYL ALCOHOL	Humco Holding Group, Inc.	d230e3a2-1cde-44a9-82c3-3dc5474b3a72	2023-12-15	Warnings	Exact identifier application number: M003
Humco Hydrogen Peroxide	HYDROGEN PEROXIDE 3%	Humco Holding Group, Inc.	2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Isopropyl Rubbing Alcohol 70%	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	c220b916-6914-435f-84e2-ba828c9916b1	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Isopropyl Rubbing Alcohol 70% Professional Pack	ISOPROPYL ALCOHOL	Humco Holding Group, Inc.	8de61fdd-8bb9-4845-9129-97bed0686a68	2023-12-15	Warnings	Exact identifier application number: M003
HUMCO Merthiolate	BENZALKONIUM CHLORIDE	Humco Holding Group, Inc.	864063a5-c6cc-4657-9cd6-51af4673bf98	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE-IODINE SPRAY 5%	Humco Holding Group, Inc.	a7bb80c4-bbc0-21ea-e053-2995a90a52c1	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE 10%	Humco Holding Group, Inc.	6064c23b-7c15-208d-e053-2991aa0a00f6	2023-12-15	Warnings	Exact identifier application number: M003
Povidone Iodine	POVIDONE IODINE GARGLE 0.5%	Humco Holding Group, Inc.	a7b9ad55-cfeb-6066-e053-2a95a90af975	2023-12-15	Warnings	Exact identifier application number: M003
Rite Aid Povidone Iodine	POVIDONE IODINE 10%	Rite Aid Corporation	5df6ff37-a4ea-d666-e053-2991aa0a9786	2023-12-15	Warnings	Exact identifier application number: M003
Rite Aid Decolorized Iodine	ETHYL ALCOHOL	Rite Aid Corporation	5e0d3664-b02a-ba28-e053-2991aa0a8a4c	2023-12-15	Warnings	Exact identifier application number: M003
De La Cruz Tincture of Iodine	IODINE AND SODIUM IODIDE AND ALCOHOL	DLC Laboratories, Inc.	5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b	2023-12-15	Warnings	Exact identifier application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIAL	ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0c73f4f5-2b1d-84ae-e063-6394a90a5d7b	2023-12-14	Warnings	Exact identifier application number: M003
TaeTu Aftercare	BENZALKONIUM CHLORIDE	Taetu LLC	dec15a4d-1a33-a78a-e053-2995a90a69fe	2023-12-14	Warnings	Exact identifier application number: M003
GNP Idoinde Tincture 2% Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Amerisource Bergen	32ad75b8-abd1-4151-a035-b6c9ae5fc888	2023-12-14	Warnings	Exact identifier application number: M003
Antibacterial Wet Wipes	BENZALKONIUM CHLORIDE	HangZhou YangYi Daily Cosmetics Technology Co., Ltd.	85d3914d-dbb8-5036-e053-2a91aa0a7cd4	2023-12-13	Warnings	Exact identifier application number: M003
AntiochPharma Rapidgel Hand Sanitizer	ALCOHOL	Weeks & Leo	0c57a9ea-de66-3ced-e063-6294a90a4b8d	2023-12-12	Warnings	Exact identifier application number: M003
antiseptic hand sanitizer 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	e9f9b7b6-fed7-10e1-e053-2a95a90a9aa6	2023-12-11	Warnings	Exact identifier application number: M003
AntiochPharma Hand Sanitizer	ALCOHOL	Weeks & Leo	a1a0d368-b004-59b8-e053-2995a90ab4b1	2023-12-11	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