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 33 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
70%	ISOPROPYL ALCOHOL	Valu Merchandisers Company	be57aa83-f097-4ff8-81f8-13d731eea4e6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	81b5a92a-27a9-41d2-bc88-920833be6638	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Valu Merchandisers Company	8235b54f-2468-45ca-bff0-9149e582e886	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Dealmed BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Dealmed Medical Supplies, LLC.	90a16a08-a7bf-418d-a95e-d735fb179a70	2026-02-16	Warnings	Exact identifier application number: M003
Iodine	IODINE	United Natural Foods, Inc. dba UNFI	8e840855-d210-4a99-b73f-6c69dcf2b6fb	2026-02-16	Warnings	Exact identifier application number: M003
IODDO IODINE	IODINE	EVI LABS	4af8552c-1f2b-84ad-e063-6394a90abb62	2026-02-16	Warnings	Exact identifier application number: M003
SaniiSwab	ETHYL ALCOHOL 62%	PolleyMed LLC	3b06f3a4-de7f-0d16-e063-6394a90af0dc	2026-02-14	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Topco Associates LLC	e258fbd2-f1dd-4ba0-ac9b-64246f2db50b	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M003
Iodine Tincture	IODINE TINCTURE	Topco Associates LLC	e648f206-cc4f-4f5f-b31c-2fb8bf2708a7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Topco Associates LLC	c3509fd3-e1bc-42bd-881e-7fb520ace9f9	2026-02-13	Warnings	Exact identifier application number: M003
First Aid Antiseptic	POVIDONE-IODINE	Walgreen Co.	b1c71ff1-8ffa-46df-9b43-86ed062c3a98	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M003
Iodine	IODINE	Walgreen Co.	d3d44c9f-4eb6-4e5b-9943-c0f80f06952d	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Walgreen Co.	eea239fe-554f-4487-9312-3ab0af27d530	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Chain Drug Consortium, LLC	d7154398-4f52-434a-b51b-b7829ccebf3b	2026-02-12	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	26e10080-d389-4994-e054-00144ff8d46c	2026-02-11	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	d980969d-694b-4c9e-a931-73beaceb51da	2026-02-11	Warnings	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	2c85e3c0-2876-31c3-e054-00144ff88e88	2026-02-11	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medline Industries, LP	52a8b96e-dd4f-449e-b819-6f3ec5a27fb4	2026-02-11	Warnings	Exact identifier application number: M003
Hydrogen Peroxide First Aid Antiseptic	HYDROGEN PEROXIDE	Medline Industries, LP	4593f51a-9bcb-4149-9ce4-4f62183fd3dd	2026-02-11	Warnings	Exact identifier application number: M003
Hydrogen peroxide	HYDROGEN PEROXIDE	Medline Industries, LP	26a67a91-ee2d-6a6c-e054-00144ff88e88	2026-02-11	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