Antiseptic

Product NDC: 51532-5300
Requested package NDC: 51532-5300-3
11-digit product format: 515325300
Labeler code: 51532
Product ID: 51532-5300_f5940692-ef5c-492d-9d0b-c8c477eebb50
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride, benzocaine
Dosage form: SPRAY
Route: TOPICAL
Labeler: Afassco Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-07-09
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength: 1 mg/mL; mg/mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51532-5300	51532-5300-3	I	Inactivated by FDA		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51532-5300-3	2025-01-30	C162847	48780-1	2cef2736-8df9-d83d-e063-dadaa90ab31f	3eb119d8-59da-405c-a5f4-a025636d394a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51532-5300-3	Antiseptic	59 mL in 1 BOTTLE, SPRAY	SPRAY	59		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 [AFASSCO INC.]	2
benzocaine	ACTIVE INGREDIENT	U3RSY48JW5	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	2
benzalkonium	ACTIVE MOIETY	7N6JUD5X6Y	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	2
benzocaine	ACTIVE MOIETY	U3RSY48JW5	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	2
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51532-5300	ANTISEPTIC (BENZALKONIUM CHLORIDE, BENZOCAINE) SPRAY [AFASSCO INC.]	4	Legacy NDC, 1 package rows	20230113_3eb119d8-59da-405c-a5f4-a025636d394a.zip

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	3eb119d8-59da-405c-a5f4-a025636d394a	4
1245229	benzalkonium chloride 1 MG/ML / benzocaine 50 MG/ML Topical Spray	SCD	3eb119d8-59da-405c-a5f4-a025636d394a	4
1245229	benzalkonium Cl 0.1 % / benzocaine 5 % Topical Spray	SY	3eb119d8-59da-405c-a5f4-a025636d394a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51532-5300-3	51532530003	59 mL in 1 BOTTLE, SPRAY (51532-5300-3)	59 ml	2012-07-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antiseptic - Afassco Inc. \| Safetec of America, Inc.	Afassco Inc. \| Safetec of America, Inc.	2023-01-12	HUMAN OTC DRUG LABEL	4