Antibacterial

Product NDC: 50157-004
11-digit product format: 501570004
Labeler code: 50157
Product ID: 50157-004_c32b409e-10ee-206d-e053-2995a90a4a46
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Brands International Corporation
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-10-08
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50157-004		I	Inactivated by FDA		2026-10-15
excluded package	package	50157-004	50157-004-64	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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50157-004-64	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50157-004-64	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50157-004-64	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50157-004-64	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50157-004-64	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50157-004-64	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50157-004-64	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50157-004-64	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50157-004-64	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50157-004-64	2025-01-30	C162847	48780-1	ba0f9c33-2351-a910-e053-dadaa90a0b85	32bd63a1-1659-409d-a92c-65d1e46fce15
50157-004-64	2021-05-25	C162847	48780-1	ba0f9c33-2351-a910-e053-dadaa90a0b85	32bd63a1-1659-409d-a92c-65d1e46fce15
50157-004-64	2021-01-29	C162847	48780-1	ba0f9c33-2351-a910-e053-dadaa90a0b85	32bd63a1-1659-409d-a92c-65d1e46fce15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50157-004-64	Antibacterial	1900 mL in 1 BOTTLE, PLASTIC	LIQUID	1900		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50157-004	ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]	4	Legacy NDC, 1 package rows	20210526_32bd63a1-1659-409d-a92c-65d1e46fce15.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	PSN	32bd63a1-1659-409d-a92c-65d1e46fce15	4
1046593	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD	32bd63a1-1659-409d-a92c-65d1e46fce15	4
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	SY	32bd63a1-1659-409d-a92c-65d1e46fce15	4
1046593	benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap	SY	32bd63a1-1659-409d-a92c-65d1e46fce15	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50157-004-64	50157000464	1900 mL in 1 BOTTLE, PLASTIC (50157-004-64)	1900 ml	2016-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antibacterial - Brands International Corporation \| Sante Manufacturing Inc	Brands International Corporation \| Sante Manufacturing Inc	2021-05-25	HUMAN OTC DRUG LABEL	4