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 114 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Henry Schein Povidone-Iodine Swabsticks	POVIDONE-IODINE	Henry Schein, Inc.	5854f241-6cfc-4e5a-ba72-92dd0703f728	2023-10-13	Warnings	Exact identifier application number: M003
DawnMist Alcohol Hand Sanitizer	ALCOHOL	Dukal LLC	a2df96a9-8514-6839-e053-2a95a90a9417	2023-10-13	Warnings	Exact identifier application number: M003
DUKAL STING RELIEF PAD	BENZOCAINE	Dukal LLC	67c1ddc7-8fde-4431-84cb-f757682d5f3e	2023-10-13	Warnings	Exact identifier application number: M003
First Aid Only First Aid/Burn	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Acme United Corporation	07245b54-b193-178e-e063-6394a90a2581	2023-10-09	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk original	ETHYL ALCOHOL	Rejoice International Corp.	06dc1730-216a-8b4d-e063-6294a90a4184	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 1.8oz with extra clip original	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	06dcf8dc-0831-475e-e063-6394a90a9fef	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 2oz 2pk original	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	06dd2427-097c-b0fa-e063-6294a90a4f82	2023-10-04	Warnings	Exact identifier application number: M003
Hand sanitizer 1.8oz with extra clip original	ETHYL ALCOHOL	Rejoice International Corp.	06da0cc1-95f2-4f88-e063-6394a90a25ea	2023-10-03	Warnings	Exact identifier application number: M003
First Aid Antiseptic Alcohol Pads Isopropyl Alcohol 70 Rite Aid	ISOPROPYL ALCOHOL	Rite Aid Corporation	aa0df5fe-62d1-407d-b8f9-a7fd9473d569	2023-10-02	Warnings	Exact identifier application number: M003
Foaming Instant Hand Sanitizer with Aloe	ETHANOL	MCKESSON MEDICAL-SURGICAL INC.	5c1f69b7-c8d8-477c-b614-47a3287b0e4c	2023-06-05	Warnings	Exact identifier application number: M003
Bactine Max Dry	LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	466404cd-c46a-4944-b1ac-3b3b17f436a1	2022-12-27	Warnings	Exact identifier application number: M003
Povidone-Iodine Pad	POVIDONE-IODINE	Shandong Haiyan Medical Manufacture Co., Ltd.	c9187a07-92d5-15ac-e053-2995a90af4cb	2022-03-19	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier application number: M003
FIRSTAR BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	28591a97-9291-48c8-a8e3-c419180331b3	2021-07-06	Warnings	Exact identifier application number: M003
Bactine Max	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	28e8a311-20a4-45a1-8d5d-ca42b101c275	2021-02-24	Warnings	Exact identifier application number: M003
Hand Sanitizer Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b0a4159a-cb07-4ce6-e053-2995a90a76e7	2020-10-02	Warnings	Exact identifier application number: M003
Sanix Alcohol Hand Rub	ALCOHOL	Topiderm, Inc	a4fbb714-4f20-400a-ab98-f1c8807ce6fc	2020-03-24	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