Hand Sanitizer

Product NDC: 77238-231
11-digit product format: 772380231
Labeler code: 77238
Product ID: 77238-231_463d3fcf-70c1-f717-e063-6394a90a3612
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: GEL
Route: TOPICAL
Labeler: DGH Pharma, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-01
Substance: BENZALKONIUM CHLORIDE
Active strength: .1 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 3 · 126 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	77238-231-31	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-48	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77238-231-44	`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	77238-231-31	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-48	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77238-231-44	`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	77238-231-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-41	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-48	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77238-231-44	`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	77238-231-31	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-41	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-48	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77238-231-44	`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	77238-231-31	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-41	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-48	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77238-231-44	`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	77238-231-31	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-41	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-48	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77238-231-44	`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	77238-231-31	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-41	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-48	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77238-231-44	`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	77238-231-31	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	77238-231-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	77238-231-24	`ed331223b511…`	`672a5bd82f5f…`

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: Hand Sanitizer
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.1 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
1049228	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
ae4311f8-fc40-38a7-e053-2a95a90ae829	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
77238-231-11	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-11	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-14	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-14	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-24	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-24	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-31	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-31	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-41	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-41	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-44	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-44	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-48	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-48	2024-01-30	Hand Sanitizer Cu - 32015
77238-231-14	2022-07-29	Hand Sanitizer Cu - 32015
77238-231-14	2022-07-29	Hand Sanitizer Cu - 32015
77238-231-24	2022-07-29	Hand Sanitizer Cu - 32015
77238-231-24	2022-07-29	Hand Sanitizer Cu - 32015
77238-231-14	2022-01-28	Hand Sanitizer Cu - 32015
77238-231-14	2022-01-28	Hand Sanitizer Cu - 32015
77238-231-24	2022-01-28	Hand Sanitizer Cu - 32015
77238-231-24	2022-01-28	Hand Sanitizer Cu - 32015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77238-231-11	Hand Sanitizer	30 mL in 1 BOTTLE, SPRAY	GEL	30	4
77238-231-14	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	4
77238-231-24	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	4
77238-231-31	Hand Sanitizer	30 mL in 1 BOTTLE, SPRAY	GEL	30	4
77238-231-41	Hand Sanitizer	30 mL in 1 BOTTLE, SPRAY	GEL	30	4
77238-231-44	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	4
77238-231-48	Hand Sanitizer	3785 mL in 1 JUG	GEL	3785	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77238-231	HAND SANITIZER (BENZALKONIUM CHLORIDE) GEL [DGH PHARMA, INC.]	4	Current NDC, Legacy NDC, 7 package rows	20220731_ae4311f8-fc40-38a7-e053-2a95a90ae829.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 38 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2c941c08-929c-43c9-966b-279086afca96	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Big Lots Stores, Inc.	2ef87a8a-58be-4123-ad03-9891e6916f1a	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cardinal Health, 110 dba Leader	d1418649-9490-4dab-b89c-9de6bb719642	2026-01-29	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ETHYL ALCOHOL	Cardinal Health, 110 dba Leader	c56cbcbf-8e0e-4dff-80d3-df420c500a93	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Cariba International	001c1fcf-2808-467c-86d8-c038513fa3b5	2026-01-29	Warnings	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Cariba International	483586f4-aab4-40c2-8925-c4f7fb22c6aa	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Cariba International	2c48f58a-a2d1-4a28-8dbf-a9d2c620bca6	2026-01-29	Warnings, Adverse reactions	Exact identifier application number: M003
New Skin Bandage	BENZETHONIUM CHLORIDE	Advantice Health, LLC	60996119-8367-4e22-b6ec-c36490635fa4	2026-01-28	Warnings	Exact identifier application number: M003
BZK Pads	BENZALKONIUM CHLORIDE	Dynarex Corporation	1409c437-ff17-481d-94be-87dd6d463ba9	2026-01-28	Warnings	Exact identifier application number: M003
Singular Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	ac2b352f-6cb2-4683-bb41-13e8ecb186bf	2026-01-27	Warnings	Exact identifier application number: M003
Singular Wipes fresh Citrus Scent	ALCOHOL	SINGULAR ENTERPRISES LLC	867a25d2-3d2c-4dad-bbe8-84195c03a87d	2026-01-27	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4906f079-8c9f-e3b0-e063-6294a90ad0f8	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4912b681-e21a-1ddf-e063-6294a90aa9f4	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491a6d77-8a84-c76d-e063-6394a90ac61f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491b55ca-2c7a-0eb7-e063-6394a90a9cb7	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491c4af8-c699-7128-e063-6294a90ae0f9	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	491de8ca-07e7-0aa3-e063-6394a90ae36f	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	492793db-7dc2-8313-e063-6394a90a52bf	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4928615e-d1a9-72b8-e063-6394a90aa7ed	2026-01-26	Warnings	Exact identifier application number: M003
Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	4943e51a-bb8e-745a-e063-6294a90a0a3d	2026-01-26	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
1049228	benzalkonium chloride 0.1 % Topical Gel	PSN	ae4311f8-fc40-38a7-e053-2a95a90ae829	4
1049228	benzalkonium chloride 0.001 MG/MG Topical Gel	SCD	ae4311f8-fc40-38a7-e053-2a95a90ae829	4
1049228	benzalkonium chloride 0.1 % Topical Gel	SY	ae4311f8-fc40-38a7-e053-2a95a90ae829	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77238-231-11	77238023111	30 mL in 1 BOTTLE, SPRAY (77238-231-11)	30 ml	2020-09-01	0000-00-00	No	No	Current
77238-231-14	77238023114	118 mL in 1 BOTTLE (77238-231-14)	118 ml	2020-09-01	0000-00-00	No	No	Current
77238-231-24	77238023124	118 mL in 1 BOTTLE (77238-231-24)	118 ml	2020-10-06	0000-00-00	No	No	Current
77238-231-31	77238023131	30 mL in 1 BOTTLE, SPRAY (77238-231-31)	30 ml	2022-06-01	0000-00-00	No	No	Current
77238-231-41	77238023141	30 mL in 1 BOTTLE, SPRAY (77238-231-41)	30 ml	2022-07-01	0000-00-00	No	No	Current
77238-231-44	77238023144	118 mL in 1 BOTTLE (77238-231-44)	118 ml	2022-07-01	0000-00-00	No	No	Current
77238-231-48	77238023148	3785 mL in 1 JUG (77238-231-48)	3785 ml	2022-07-01	0000-00-00	No	No	Current