Byotrol Antibacterial Foaming Hand Sanitizer

Product NDC: 42719-346
11-digit product format: 427190346
Labeler code: 42719
Product ID: 42719-346_ca36ae2a-21c1-46a3-96cc-de95950d92ae
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: LIQUID
Route: TOPICAL
Labeler: Byotrol, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-08
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 1 mg/mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42719-346		I	Inactivated by FDA	2026-10-05
excluded package	package	42719-346	42719-346-06	I	Inactivated by FDA	2026-10-05
excluded package	package	42719-346	42719-346-50	I	Inactivated by FDA	2026-10-05
excluded package	package	42719-346	42719-346-51	I	Inactivated by FDA	2026-10-05
excluded package	package	42719-346	42719-346-99	I	Inactivated by FDA	2026-10-05

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 · 110 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 package	package	42719-346-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42719-346-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42719-346-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42719-346-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42719-346-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42719-346-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42719-346-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42719-346-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42719-346-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42719-346-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42719-346-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42719-346-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42719-346-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42719-346-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42719-346-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42719-346-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42719-346-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42719-346-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42719-346-99	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42719-346-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42719-346-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42719-346-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42719-346-99	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42719-346-51	`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 package	package	42719-346-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42719-346-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42719-346-99	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42719-346-51	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
42719-346-06	Drug Facts
42719-346-50	Drug Facts
42719-346-51	Drug Facts
42719-346-99	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42719-346-06	Byotrol Antibacterial Foaming Hand Sanitizer	1250 mL in 1 CARTRIDGE	LIQUID	1250	1
42719-346-50	Byotrol Antibacterial Foaming Hand Sanitizer	500 mL in 1 BOTTLE	LIQUID	500	1
42719-346-51	Byotrol Antibacterial Foaming Hand Sanitizer	210 mL in 1 BOTTLE	LIQUID	210	1
42719-346-99	Byotrol Antibacterial Foaming Hand Sanitizer	50 mL in 1 BOTTLE	LIQUID	50	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
C12-15 PARETH-7	INACTIVE INGREDIENT	3XY03A79QH	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
CETRIMONIUM CHLORIDE	INACTIVE INGREDIENT	UC9PE95IBP	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
DIHYDROXYETHYL COCAMINE OXIDE	INACTIVE INGREDIENT	8AR51R3BL5	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
GLYCERETH-17 COCOATE	INACTIVE INGREDIENT	3057VPT0KC	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
LAURTRIMONIUM CHLORIDE	INACTIVE INGREDIENT	A81MSI0FIC	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
POLIHEXANIDE	INACTIVE INGREDIENT	322U039GMF	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42719-346	BYOTROL ANTIBACTERIAL FOAMING HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [BYOTROL, INC.]	1	Legacy NDC, 4 package rows	20130311_1b45f435-dbcf-4560-a189-72c7ef48cfd9.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
1020365	benzalkonium chloride 0.13 % Topical Foam	PSN	1b45f435-dbcf-4560-a189-72c7ef48cfd9	1
1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD	1b45f435-dbcf-4560-a189-72c7ef48cfd9	1
1020365	benzalkonium chloride 0.13 % Topical Foam	SY	1b45f435-dbcf-4560-a189-72c7ef48cfd9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
42719-346-06	42719034606	1250 mL in 1 CARTRIDGE	1250 ml	Historical
42719-346-50	42719034650	500 mL in 1 BOTTLE	500 ml	Historical
42719-346-51	42719034651	210 mL in 1 BOTTLE	210 ml	Historical
42719-346-99	42719034699	50 mL in 1 BOTTLE	50 ml	Historical