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 57 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AshleyBelle Moisturizing Hand Sanitizer Soft Berry	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421ce569-f2d3-c1e0-e063-6294a90a822f	2025-10-26	Warnings	Exact identifier application number: M003
JOLLY RANCHER HAND SANITIZER BLUE RASPBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42d1f66d-45f6-bb9a-e063-6394a90a06aa	2025-10-26	Warnings	Exact identifier application number: M003
Alcohol Wipe	ISOPROPYL ALCOHOL	Cardinal Health	c95bfab6-bab4-79f3-e053-2995a90a8091	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	3a6e97d7-7eea-f7ca-e063-6394a90a4ecd	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	3a6cabf7-9310-cba5-e063-6394a90a3f91	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	39529f87-ed4e-52b8-e063-6394a90af879	2025-10-23	Warnings	Exact identifier application number: M003
CareTouch	ETHYL ALCOHOL	Phoenix Healthcare Solutions LLC	f0b55f6c-4afd-2154-e053-2995a90afcfa	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	e8cdf841-cf56-26cc-e053-2995a90aab51	2025-10-23	Warnings	Exact identifier application number: M003
Povidone Iodine Prep	POVIDONE IODINE	PHOENIX HEALTHCARE SOLUTIONS, LLC	c17603f2-3548-4225-b611-216c2763e51f	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c601d9ea-25ab-cd1d-e053-2995a90ae252	2025-10-23	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Cardinal Health	cc0a6e1e-ec95-cb48-e053-2a95a90ac0ce	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions, LLC	d07d103d-420b-5307-e053-2995a90a14f5	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Htl-Strefa, Inc.	d72ddf5a-72e7-c37d-e053-2995a90ad48b	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c92524fd-8b91-592d-e053-2a95a90a88c6	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep	ISOPROPYL ALCOHOL	Cardinal Health	89852887-ae62-4277-b615-75663afb5436	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Henry Schein, Inc.	b9826baa-b976-14c6-e053-2995a90a7d09	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Phoenix Healthcare Solutions LLC	c9261c7f-9f8f-6476-e053-2a95a90a0e93	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Rugby Laboratories	ea28b27a-456e-4042-b769-f06072759933	2025-10-23	Warnings	Exact identifier application number: M003
School Health Sterile Alcohol Prep Pad	ISOPROPYL ALCOHOL	School Health Corporation	718640e1-826b-4b65-a021-3f82cd4c983a	2025-10-23	Warnings	Exact identifier application number: M003
Alcohol Prep Pads	ISOPROPYL ALCOHOL	Henry Schein, Inc.	215fa8ac-c9b6-42b6-ae9d-a08d7ff0900f	2025-10-23	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