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 90 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMADIVE ULTRACARE - TETRAID	BENZALKONIUM CHLORIDE	Releaf Technologies LLC	025c0b33-73ca-334b-e063-6394a90ad668	2025-01-09	Warnings	Exact identifier application number: M003
Drs. pharmacy triple antibiotic	BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT	OL PHARMA TECH, LLC	bb730976-0045-c0ae-e053-2a95a90af34e	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Antibiotic Bacitracin	BACITRACIN	OL PHARMA TECH, LLC	c26493c4-0bc1-5fdc-e053-2995a90a81e6	2025-01-09	Warnings	Exact identifier application number: M003
Drs. Pharmacy Triple Antibiotic Plus	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE	OL PHARMA TECH, LLC Drs PHARMACY	d037bfb8-0d8c-4eda-e053-2995a90ae1f2	2025-01-09	Warnings	Exact identifier application number: M003
BACTINE MAX	BACTINE MAX WOUND WASH	WellSpring Pharmaceutical Corporation	39b26c28-93e0-41a9-8018-f73525ebc015	2025-01-08	Warnings	Exact identifier application number: M003
sterile	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0658a0c8-f5ec-b380-e063-6394a90afff5	2025-01-08	Warnings	Exact identifier application number: M003
Betadine Surgical Scrub	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	1ad39e11-ea1e-44a4-8224-93f8135436c2	2025-01-06	Warnings	Exact identifier application number: M003
First Aid Antiseptic	BENZALKONIUM CHLORIDE	Water-Jel Technologies	2b3cb958-c0c4-47fd-8338-7c7821135f2b	2025-01-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ALCOHOL	Water-Jel Technologies	54e62104-8076-41db-afe5-6dc5c3563acc	2025-01-06	Warnings	Exact identifier application number: M003
Betadine Solution	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	41891599-420e-48d2-8e31-d28a2209e383	2025-01-06	Warnings	Exact identifier application number: M003
Signature Care Alcohol Prep Pad	ISOPROPYL ALCOHOL	Better Living Brands LLC	adc87331-1aa1-3457-e053-2a95a90a7eb1	2025-01-03	Warnings	Exact identifier application number: M003
Alcohol Extra-Thick	ISOPROPYL ALCOHOL	Meijer Distribution Inc	0b02643d-ea14-4877-ae9c-f0749d1b2d10	2025-01-03	Warnings	Exact identifier application number: M003
Premier Value	ISOPROPYL ALCOHOL	Pharmacy Value Alliance, LLC	d2baa47e-9673-7f23-e053-2a95a90adcb7	2025-01-03	Warnings	Exact identifier application number: M003
CVS Alcohol Prep	ISOPROPYL ALCOHOL	CVS Pharmacy	88f761c1-cb50-4edc-9a54-43444378eff7	2025-01-03	Warnings	Exact identifier application number: M003
Sterile Alcohol	ISOPROPYL ALCOHOL	Chain Drug Marketing Association Inc	55922632-3768-4450-9389-ba7d7d91f2c9	2025-01-03	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	CASAD Company, Inc	1e314157-c64e-492a-89ad-2b28831d551d	2025-01-03	Warnings	Exact identifier application number: M003
Betadine	POVIDONE-IODINE	Atlantis Consumer Healthcare, Inc.	00002127-02bc-4c66-b0c3-ca29d8224afc	2025-01-02	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON CANDY	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	2d02e4d6-8751-b5bc-e063-6394a90a9d97	2025-01-01	Warnings	Exact identifier application number: M003
COVISIDE HAND SANITIZER	ISOPROPYL ALCOHOL	CREAGEN INC	a9f07fcd-4d5c-362c-e053-2a95a90a2e79	2024-12-30	Warnings	Exact identifier application number: M003
KEEPAN A	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	a30679d5-5507-499d-9d9f-498095fd32ac	2024-12-30	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