BAK

Product NDC: 12745-145
11-digit product format: 127450145
Labeler code: 12745
Product ID: 12745-145_55a6cc20-503e-416a-e063-6394a90aec61
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: LIQUID
Route: TOPICAL
Labeler: Medical Chemical Corporation
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1954-06-15
Substance: BENZALKONIUM CHLORIDE
Active strength: .1713 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 42 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
2025-08-27 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	12745-145-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	12745-145-02	`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	12745-145-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	12745-145-02	`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	12745-145-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	12745-145-02	`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	12745-145-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	12745-145-02	`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	12745-145-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	12745-145-02	`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	12745-145-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	12745-145-02	`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	12745-145-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	12745-145-02	`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	12745-145-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	12745-145-02	`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	12745-145-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	12745-145-02	`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	12745-145-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	12745-145-02	`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	12745-145-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	12745-145-02	`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 package	package	12745-145-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	12745-145-02	`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 package	package	12745-145-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	12745-145-02	`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 package	package	12745-145-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	12745-145-02	`1332a3947898…`	`d4bfe170f9cd…`

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: BAK
Brand name suffix: 1 750
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.1713 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049254	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
d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
12745-145-01	BAK 1:750 Label
12745-145-01	BAK 1:750 Label
12745-145-02	BAK 1:750 Label
12745-145-02	BAK 1:750 Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
12745-145-01	BAK1 750	473 mL in 1 BOTTLE, PLASTIC	LIQUID	473		15
12745-145-02	BAK1 750	3785 mL in 1 BOTTLE, PLASTIC	LIQUID	3785		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	BAK 1 750 (BENZALKONIUM CHLORIDE) LIQUID [MEDICAL CHEMICAL CORPORATION]	7
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	BAK 1 750 (BENZALKONIUM CHLORIDE) LIQUID [MEDICAL CHEMICAL CORPORATION]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	BAK 1 750 (BENZALKONIUM CHLORIDE) LIQUID [MEDICAL CHEMICAL CORPORATION]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
12745-145	BAK 1 750 (BENZALKONIUM CHLORIDE) LIQUID [MEDICAL CHEMICAL CORPORATION]	14	Current NDC, Legacy NDC, 2 package rows	20220118_d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8.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 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentian Violet	GENTIAN VIOLET	Vitamex USA, Corp	21742061-fc0b-f750-e063-6394a90a7508	2026-08-26	Warnings	Exact identifier application number: M003
Mercurochrome	BENZALKONIUM CHLORIDE	Vitamex USA, Corp	21652b11-715d-0c54-e063-6294a90a8855	2026-08-26	Warnings	Exact identifier application number: M003
Scentsational Square Hand Sanitizer	HAND SANITIZER	Raining Rose, Inc.	59f9bacf-80dc-3468-e063-6294a90a0ae1	2026-08-26	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59fa27b4-dfd4-720b-e063-6394a90af659	2026-08-26	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59fb22d6-f6a4-42cd-e063-6394a90a859a	2026-08-26	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59fbb054-461e-aa6e-e063-6394a90a470c	2026-08-26	Warnings	Exact identifier application number: M003
Curad Alcohol Sterile, Thick	ISOPROPYL ALCOHOL	Medline Industries, LP	b769898e-a73f-4323-af15-bee8dbe455b6	2026-08-25	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Your Military Exchanges	a71734c6-6b92-4d3d-84d1-a07f592fa828	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59e742a6-61f9-59f7-e063-6394a90a8738	2026-08-25	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59e7dfb1-49b5-d2be-e063-6394a90a04d8	2026-08-25	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59d3c369-86aa-8ebd-e063-6394a90aa806	2026-08-24	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59d7fc3c-3a93-153d-e063-6394a90ac647	2026-08-24	Warnings	Exact identifier application number: M003
Be Smart Get Prepared Hand Sanitizer	ALCOHOL	Total Resources International, Inc	23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e	2026-08-24	Warnings	Exact identifier application number: M003
Claravie	BENZALKONIUM CHLORIDE	Gentell LLC	59887af3-9b22-9664-e063-6294a90a57c6	2026-08-21	Warnings	Exact identifier application number: M003
hand sanitizer- light blue 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	598a96f0-33fe-40aa-e063-6394a90aeacb	2026-08-21	Warnings	Exact identifier application number: M003
hand sanitizer- light green 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	598a165a-90ff-e00c-e063-6394a90a3351	2026-08-21	Warnings	Exact identifier application number: M003
Family Beauty Antibacterial Hand Wipes	BENZALKONIUM CHLORIDE	Zhejiang Bright Care Co., Ltd.	6ff604f7-4011-4f0e-aa2d-a46e1a973d13	2026-08-21	Warnings	Exact identifier application number: M003
hand sanitizer- light purple 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	598b7bb8-0d2e-a66f-e063-6294a90a45b8	2026-08-21	Warnings	Exact identifier application number: M003
hand sanitizer- light yellow 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	598bf8cd-2a79-8b56-e063-6394a90a42a8	2026-08-21	Warnings	Exact identifier application number: M003
hand sanitizer- light pink 01	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	598c41f0-908d-df52-e063-6394a90a3c8d	2026-08-21	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049254	benzalkonium chloride 0.13 % Topical Solution	PSN	d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8	15
1049254	benzalkonium chloride 1.3 MG/ML Topical Solution	SCD	d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8	15
1049254	benzalkonium chloride 0.13 % Topical Solution	SY	d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
12745-145-01	12745014501	473 mL in 1 BOTTLE, PLASTIC (12745-145-01)	473 ml	1954-06-15	0000-00-00	No	No	Current
12745-145-02	12745014502	3785 mL in 1 BOTTLE, PLASTIC (12745-145-02)	3785 ml	1954-06-15	0000-00-00	No	No	Current

BAK