Hygieni-Klean Hand Sanitizer Gel

Product NDC: 78174-013
11-digit product format: 781740013
Labeler code: 78174
Product ID: 78174-013_f067ad5c-d08f-442e-bb6d-d5ce547a7905
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Custom Chemical Services, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-01-03
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 L/100L
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78174-013		I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78174-013	78174-013-07	I	Inactivated by FDA	2026-10-05

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 2 · 120 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	78174-013-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78174-013-03	`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	78174-013-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78174-013-03	`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	78174-013-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78174-013-03	`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	78174-013-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78174-013-03	`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	78174-013-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78174-013-03	`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	78174-013-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78174-013-03	`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	78174-013-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78174-013-03	`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	78174-013-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78174-013-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78174-013-07	`ed331223b511…`	`672a5bd82f5f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78174-013-01	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-02	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-03	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-04	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-05	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-06	5ba5f3cf-bbd5-4155-becc-797da558a640
78174-013-07	5ba5f3cf-bbd5-4155-becc-797da558a640

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78174-013-01	Hygieni-Klean Hand Sanitizer Gel	3.78541 L in 1 JUG	GEL	3.78541	1
78174-013-02	Hygieni-Klean Hand Sanitizer Gel	0.946353 L in 1 BOTTLE	GEL	0.946353	1
78174-013-03	Hygieni-Klean Hand Sanitizer Gel	0.473176 L in 1 BOTTLE	GEL	0.473176	1
78174-013-04	Hygieni-Klean Hand Sanitizer Gel	0.354882 L in 1 BOTTLE	GEL	0.354882	1
78174-013-05	Hygieni-Klean Hand Sanitizer Gel	0.236588 L in 1 BOTTLE	GEL	0.236588	1
78174-013-06	Hygieni-Klean Hand Sanitizer Gel	0.118294 L in 1 BOTTLE	GEL	0.118294	1
78174-013-07	Hygieni-Klean Hand Sanitizer Gel	0.0591471 L in 1 BOTTLE	GEL	0.0591471	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78174-013	HYGIENI-KLEAN HAND SANITIZER GEL (ALCOHOL) GEL [CUSTOM CHEMICAL SERVICES, LLC]	1	Legacy NDC, 7 package rows	20210104_5ba5f3cf-bbd5-4155-becc-797da558a640.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1305100	ethanol 75 % Topical Gel	PSN	5ba5f3cf-bbd5-4155-becc-797da558a640	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	5ba5f3cf-bbd5-4155-becc-797da558a640	1
1305100	ethanol 75 % Topical Gel	SY	5ba5f3cf-bbd5-4155-becc-797da558a640	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78174-013-01	78174001301	3.78541 L in 1 JUG (78174-013-01)	3.78541 l	2021-01-03	0000-00-00	No	No	Current
78174-013-02	78174001302	.946353 L in 1 BOTTLE (78174-013-02)		2021-01-03	0000-00-00	No	No	Current
78174-013-03	78174001303	.473176 L in 1 BOTTLE (78174-013-03)		2021-01-03	0000-00-00	No	No	Current
78174-013-04	78174001304	.354882 L in 1 BOTTLE (78174-013-04)		2021-01-03	0000-00-00	No	No	Current
78174-013-05	78174001305	.236588 L in 1 BOTTLE (78174-013-05)		2021-01-03	0000-00-00	No	No	Current
78174-013-06	78174001306	.118294 L in 1 BOTTLE (78174-013-06)		2021-01-03	0000-00-00	No	No	Current
78174-013-07	78174001307	.0591471 L in 1 BOTTLE (78174-013-07)		2021-01-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hygieni-Klean Hand Sanitizer Gel - Custom Chemical Services, LLC	Custom Chemical Services, LLC	2021-01-03	HUMAN OTC DRUG LABEL	1