Hand Sanitizer

Product NDC: 79516-9664
11-digit product format: 795169664
Labeler code: 79516
Product ID: 79516-9664_aaf6247d-8271-05ae-e053-2a95a90afbc0
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: One Sanitizer, LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 L/100L
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	79516-9664		I	Inactivated by FDA	2026-10-05
excluded product	product	79516-9664		I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-7	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-8	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-9	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-1	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-2	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-3	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-4	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-5	I	Inactivated by FDA	2026-10-05
excluded package	package	79516-9664	79516-9664-6	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 4 · 198 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79516-9664-4	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79516-9664-4	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79516-9664-4	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79516-9664-4	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79516-9664-4	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79516-9664-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79516-9664-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79516-9664-3	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
79516-9664-1	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-2	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-3	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-4	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-5	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-6	d6a99b39-77ec-a426-e053-dadaa90af4c2	a7aa183f-8437-ff69-e053-2a95a90af0e0
79516-9664-7	d6a99b39-f7ad-a426-e053-dadaa90af4c2	TOP NOW
79516-9664-8	d6a99b39-f7ad-a426-e053-dadaa90af4c2	TOP NOW
79516-9664-9	d6a99b39-f7ad-a426-e053-dadaa90af4c2	TOP NOW

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79516-9664-1	Hand Sanitizer	0.03 L in 1 BOTTLE, PLASTIC	GEL	0.03	2
79516-9664-2	Hand Sanitizer	0.12 L in 1 BOTTLE, PLASTIC	GEL	0.12	2
79516-9664-3	Hand Sanitizer	0.252 L in 1 BOTTLE, PUMP	GEL	0.252	2
79516-9664-4	Hand Sanitizer	0.5 L in 1 BOTTLE, PUMP	GEL	0.5	2
79516-9664-5	Hand Sanitizer	1.893 L in 1 BOTTLE, PUMP	GEL	1.893	2
79516-9664-6	Hand Sanitizer	3.785 L in 1 BOTTLE, PUMP	GEL	3.785	2
79516-9664-7	Hand Sanitizer	0.12 L in 1 BOTTLE, SPRAY	GEL	0.12	1
79516-9664-8	Hand Sanitizer	1.893 L in 1 BOTTLE, PLASTIC	GEL	1.893	1
79516-9664-9	Hand Sanitizer	3.785 L in 1 BOTTLE, PLASTIC	GEL	3.785	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79516-9664	HAND SANITIZER (ALCOHOL) GEL HAND SANITIZER (WHO RECOMMENDED HAND RUB) LIQUID [ONE SANITIZER, LLC]	2	Legacy NDC, 6 package rows	20200722_a7aa183f-8437-ff69-e053-2a95a90af0e0.zip
79516-9664	HAND SANITIZER (ALCOHOL) GEL [ONE SANITIZER LLC]	1	Legacy NDC, 3 package rows	20200715_aa55e2fa-424d-2477-e053-2995a90aa7c7.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
1041498	ethanol 80 % Topical Gel	PSN	a7aa183f-8437-ff69-e053-2a95a90af0e0	2
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a7aa183f-8437-ff69-e053-2a95a90af0e0	2
1041498	ethanol 80 % Topical Gel	SY	a7aa183f-8437-ff69-e053-2a95a90af0e0	2
1041498	ethanol 80 % Topical Gel	PSN	aa55e2fa-424d-2477-e053-2995a90aa7c7	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	aa55e2fa-424d-2477-e053-2995a90aa7c7	1
1041498	ethanol 80 % Topical Gel	SY	aa55e2fa-424d-2477-e053-2995a90aa7c7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79516-9664-1	79516966401	.03 L in 1 BOTTLE, PLASTIC (79516-9664-1)		2020-06-01	0000-00-00	No	No	Current
79516-9664-2	79516966402	.12 L in 1 BOTTLE, PLASTIC (79516-9664-2)		2020-06-01	0000-00-00	No	No	Current
79516-9664-3	79516966403	.252 L in 1 BOTTLE, PUMP (79516-9664-3)		2020-06-01	0000-00-00	No	No	Current
79516-9664-4	79516966404	.5 L in 1 BOTTLE, PUMP (79516-9664-4)		2020-06-01	0000-00-00	No	No	Current
79516-9664-5	79516966405	1.893 L in 1 BOTTLE, PUMP (79516-9664-5)	1.893 l	2020-06-01	0000-00-00	No	No	Current
79516-9664-6	79516966406	3.785 L in 1 BOTTLE, PUMP (79516-9664-6)	3.785 l	2020-06-01	0000-00-00	No	No	Current
79516-9664-7	79516966407	.12 L in 1 BOTTLE, SPRAY (79516-9664-7)		2020-03-30	0000-00-00	No	No	Current
79516-9664-8	79516966408	1.893 L in 1 BOTTLE, PLASTIC (79516-9664-8)	1.893 l	2020-03-30	0000-00-00	No	No	Current
79516-9664-9	79516966409	3.785 L in 1 BOTTLE, PLASTIC (79516-9664-9)	3.785 l	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - One Sanitizer, LLC \| Brenntag North America Inc	One Sanitizer, LLC \| Brenntag North America Inc	2020-07-21	HUMAN OTC DRUG LABEL	2
TOP NOW	One Sanitizer LLC \| Brenntag North America	2020-07-13	HUMAN OTC DRUG LABEL	1