Antiseptic

Product NDC: 61010-5300
Requested package NDC: 61010-5300-0
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Antiseptic
Listing expiration: 2026-12-31

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 1 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BIOPURE50CT ANTI BACTERIAL HAND WIPES	BIOPURE50CT ANTI BACTERIAL HAND WIPES	Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd	57d3e290-1343-4075-e063-6394a90a41a6	2026-07-30	Warnings	Exact identifier application number: M003
Meridian Unwrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	c2d13d97-99ce-4a24-bdd6-684fbbf242a4	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Gingerbread/Spiced Cranberry/Vanilla Heaven/Pistachio Brulee	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57bd148e-f9eb-dfb6-e063-6394a90a1e12	2026-07-29	Warnings	Exact identifier application number: M003
School Health	ISOPROPYL ALCOHOL	School Health Corporation	db5d0b22-f2d7-23e5-e053-2a95a90aeb51	2026-07-29	Warnings	Exact identifier application number: M003
Jelly Smack	BENZALKONIUM CHLORIDE	VULCAN MICROBIAL CORPORATION	eb79e11a-6c29-556b-e053-2a95a90a728a	2026-07-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer 4pk - Fresh Calming Lavender/Sweet Citrus/Coconut Breeze/ Cucumber Melon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57cb54f7-07be-524f-e063-6294a90a2c94	2026-07-29	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	57ccc28b-5f5f-30ec-e063-6294a90a081c	2026-07-29	Warnings	Exact identifier application number: M003
Meridian wrapped antibacterial deodorant	BENZETHONIUM CHLORIDE	Bob Barker Company Inc.	de60d4d5-87bc-4400-94e2-8307a9bb0870	2026-07-29	Warnings	Exact identifier application number: M003
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	4 Visions	57ac6fef-21de-e214-e063-6394a90a6c9e	2026-07-28	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	4 Visions LLC	57acc1ff-2564-1e61-e063-6394a90a3c91	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Vanilla Sugar Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adcf08-9785-016d-e063-6294a90aa8d4	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Cherry Kiss Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adec54-6099-0694-e063-6394a90a4a0f	2026-07-28	Warnings	Exact identifier application number: M003
It Bag Strawberry Love Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	57adfb22-cb7a-39e7-e063-6294a90a3079	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Pouch-Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b6f063-9afa-94c9-e063-6394a90a2c35	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Lavender Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7250c-49cd-3076-e063-6294a90ab757	2026-07-28	Warnings	Exact identifier application number: M003
Magicare alcohol hand sanitizing wipes	ALCOHOL HAND SANITIZING WIPES	Guangzhou Baihua Co., Ltd	57b7531b-77f7-f63b-e063-6394a90aa81c	2026-07-28	Warnings	Exact identifier application number: M003
Magicare alcohol hand sanitizing wipes	ALCOHOL HAND SANITIZING WIPES	Guangzhou Baihua Co., Ltd	57b7b74e-6df9-4384-e063-6394a90a09c4	2026-07-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Fig Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7b91f-1874-f2f0-e063-6294a90a4060	2026-07-28	Warnings	Exact identifier application number: M003
Walgreens Hand Sanitizer Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	57b7f5fd-0472-3a84-e063-6294a90adb9e	2026-07-28	Warnings	Exact identifier application number: M003
Liquid Bandage	BENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDE	Meijer Distribution Inc	036fd504-0cda-60ab-e063-6394a90a2f18	2026-07-27	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

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