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 25 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Hand Sanitizer 3pk with Leather Case	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4f036ba3-3f21-d04b-e063-6294a90ad7d7	2026-04-09	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Pistachio Creme	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eeedd3e-d4b4-9967-e063-6394a90abf33	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer French Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eef33c2-695a-3a32-e063-6394a90a0a7b	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows Pink	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eefc5bc-7dd4-e4c8-e063-6394a90a9a51	2026-04-08	Warnings	Exact identifier application number: M003
Verifine Alcohol Swabs	ALCOHOL SWABS	Promisemed Hangzhou Meditech Co.,LTD.	4ef56b6c-ad46-2d02-e063-6294a90ad407	2026-04-08	Warnings	Exact identifier application number: M003
Rubbing	ETHYL ALCOHOL	Perrigo Direct, Inc	ba2266d7-da25-495a-b035-97e149551c30	2026-04-08	Warnings, Adverse reactions	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows Purple	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4efeb523-0a73-2e48-e063-6394a90aac5e	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels Red	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4efefd07-c1df-695a-e063-6294a90a51eb	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels Purple	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4eff601c-7bcd-1ddd-e063-6294a90a8040	2026-04-08	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Ocean Breeze	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4effb28e-fa83-5a06-e063-6394a90aa2f5	2026-04-08	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Perrigo Direct, Inc	f953a249-07ad-40a1-8aea-b2d419fd3d4d	2026-04-07	Warnings, Adverse reactions	Exact identifier application number: M003
50% Rubbing	ISOPROPYL ALCOHOL	Perrigo Direct, Inc	698bede7-4fc1-4e85-8ac4-d735f409cfae	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Amazon.com Services LLC	5369424a-ccbd-4dc6-af6b-7876484a9fe6	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M003
Caring Mill Triple Hand Sanitizer with Lavender	ETHYL ALCOHOL	FSA Store Inc. (Caring Mills)	4b0b5436-a1ce-cfa6-e063-6394a90a2efe	2026-04-04	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Passion Paradise	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e850ea9-0999-12b4-e063-6394a90af406	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Tropical Mango	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85630a-6d18-e6a4-e063-6394a90a1d12	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Coco Cabana	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85923b-6b8c-f9a2-e063-6294a90a0d8e	2026-04-02	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer Sea Breeze	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	4e85e279-7751-8bd7-e063-6294a90a095b	2026-04-02	Warnings	Exact identifier application number: M003
Povidone Iodine 10%	POVIDONE IODINE	Farmacias De Similares TX LLC	4e6baed0-ea31-79e2-e063-6294a90a3bb1	2026-04-01	Warnings	Exact identifier application number: M003
FRESH LINES SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5005d615-d9c3-a46d-e063-6394a90af88a	2026-04-01	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