CurX Antimicrobial Gel

Product NDC: 69578-466
11-digit product format: 695780466
Labeler code: 69578
Product ID: 69578-466_de59e4bd-ddf4-4364-ae57-f1be831a3f81
Type: HUMAN OTC DRUG
Nonproprietary name: benzalkonium chloride
Dosage form: GEL
Route: TOPICAL
Labeler: Global Health Solutions, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-10-28
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69578-466		I	Inactivated by FDA	2026-10-12
excluded product	product	69578-466		I	Inactivated by FDA	2026-10-12
excluded package	package	69578-466	69578-466-45	I	Inactivated by FDA	2026-10-12
excluded package	package	69578-466	69578-466-05	I	Inactivated by FDA	2026-10-12

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69578-466-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69578-466-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69578-466-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69578-466-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69578-466-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69578-466-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69578-466-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69578-466-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69578-466-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69578-466-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69578-466-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69578-466-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69578-466-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69578-466-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69578-466-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69578-466-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69578-466-45	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69578-466-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69578-466-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69578-466-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69578-466-45	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69578-466-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69578-466-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69578-466-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69578-466-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69578-466-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69578-466-45	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69578-466-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69578-466-45	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69578-466-05	`1332a3947898…`	`d4bfe170f9cd…`

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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69578-466-05	2020-01-31	C162847	48780-1	9d75b9d0-d1f8-f424-e053-dadaa90a57ce	DRUG FACTS
69578-466-45	2020-01-31	C162847	48780-1	9d75b9cf-cfdd-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69578-466-05	CurX Antimicrobial Gel	5 g in 1 TUBE	GEL	5		2
69578-466-45	CurX Antimicrobial Gel	45 g in 1 TUBE	GEL	45		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
POLIHEXANIDE	INACTIVE INGREDIENT	322U039GMF	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
POLIHEXANIDE	INACTIVE INGREDIENT	322U039GMF	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69578-466	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2	Legacy NDC, 1 package rows	20151113_03ea1784-cc43-4b6f-82a2-680296340fbd.zip
69578-466	CURX ANTIMICROBIAL GEL (BENZALKONIUM CHLORIDE) GEL [GLOBAL HEALTH SOLUTIONS, LLC]	2	Legacy NDC, 1 package rows	20151106_5c7cedd8-bd6f-4831-8899-98fd5dee3815.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
1098199	benzalkonium chloride 0.13 % Topical Gel	PSN	03ea1784-cc43-4b6f-82a2-680296340fbd	2
1098199	benzalkonium chloride 0.13 % Topical Gel	PSN	5c7cedd8-bd6f-4831-8899-98fd5dee3815	2
1098199	benzalkonium chloride 0.0013 MG/MG Topical Gel	SCD	03ea1784-cc43-4b6f-82a2-680296340fbd	2
1098199	benzalkonium chloride 0.0013 MG/MG Topical Gel	SCD	5c7cedd8-bd6f-4831-8899-98fd5dee3815	2
1098199	benzalkonium chloride 0.13 % Topical Gel	SY	03ea1784-cc43-4b6f-82a2-680296340fbd	2
1098199	benzalkonium chloride 0.13 % Topical Gel	SY	5c7cedd8-bd6f-4831-8899-98fd5dee3815	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69578-466-05	69578046605	5 g in 1 TUBE	5 g	Historical
69578-466-45	69578046645	45 g in 1 TUBE	45 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Global Health Solutions, LLC	2015-10-28	HUMAN OTC DRUG LABEL	2
DRUG FACTS	Global Health Solutions, LLC	2015-10-28	HUMAN OTC DRUG LABEL	2