Hand Sanitizer

Product NDC: 80869-420
11-digit product format: 808690420
Labeler code: 80869
Product ID: 80869-420_b69df3b8-ec3c-06a1-e053-2995a90acc82
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: GMA Supplies LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/100mL
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80869-420		I	Inactivated by FDA	2026-10-05
excluded product	product	80869-420		I	Inactivated by FDA	2026-10-05
excluded product	product	80869-420		I	Inactivated by FDA	2026-10-05
excluded product	product	80869-420		I	Inactivated by FDA	2026-10-05
excluded package	package	80869-420	80869-420-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80869-420	80869-420-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80869-420	80869-420-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80869-420	80869-420-04	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 3 · 152 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 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	80869-420-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80869-420-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80869-420-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80869-420-03	`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 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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80869-420-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80869-420-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80869-420-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80869-420-03	`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 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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80869-420-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80869-420-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80869-420-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80869-420-03	`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 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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80869-420-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80869-420-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80869-420-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80869-420-03	`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 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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80869-420-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80869-420-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80869-420-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80869-420-03	`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 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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80869-420-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80869-420-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80869-420-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80869-420-03	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80869-420-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80869-420-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80869-420-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80869-420-03	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
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 product	product		`ed331223b511…`	`672a5bd82f5f…`

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
80869-420-01	d6a99b39-66ff-a426-e053-dadaa90af4c2	b1cf84af-7556-a9d0-e053-2a95a90adad9
80869-420-02	d6a99b39-4c42-a426-e053-dadaa90af4c2	b1cfaa2a-b913-8798-e053-2a95a90ab4e6
80869-420-03	d6a99b39-6702-a426-e053-dadaa90af4c2	b1cfc126-63f3-4ad9-e053-2a95a90a86cf
80869-420-04	d6a99b39-e7bd-a426-e053-dadaa90af4c2	b1cfdb43-564d-3fd8-e053-2995a90a6806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80869-420-01	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	2
80869-420-02	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	2
80869-420-03	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	2
80869-420-04	Hand Sanitizer	4000 mL in 1 BOTTLE	GEL	4000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80869-420	HAND SANITIZER (ALCOHOL) GEL [GMA SUPPLIES LLC]	2	Legacy NDC, 1 package rows	20201217_b1cfc126-63f3-4ad9-e053-2a95a90a86cf.zip
80869-420	HAND SANITIZER (ALCOHOL) GEL [GMA SUPPLIES LLC]	2	Legacy NDC, 1 package rows	20201217_b1cfdb43-564d-3fd8-e053-2995a90a6806.zip
80869-420	HAND SANITIZER (ALCOHOL) GEL [GMA SUPPLIES LLC]	2	Legacy NDC, 1 package rows	20201217_b1cf84af-7556-a9d0-e053-2a95a90adad9.zip
80869-420	HAND SANITIZER (ALCOHOL) GEL [GMA SUPPLIES LLC]	2	Legacy NDC, 1 package rows	20201217_b1cfaa2a-b913-8798-e053-2a95a90ab4e6.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
581662	ethanol 70 % Topical Gel	PSN	b1cf84af-7556-a9d0-e053-2a95a90adad9	2
581662	ethanol 70 % Topical Gel	PSN	b1cfaa2a-b913-8798-e053-2a95a90ab4e6	2
581662	ethanol 70 % Topical Gel	PSN	b1cfc126-63f3-4ad9-e053-2a95a90a86cf	2
581662	ethanol 70 % Topical Gel	PSN	b1cfdb43-564d-3fd8-e053-2995a90a6806	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	b1cf84af-7556-a9d0-e053-2a95a90adad9	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	b1cfaa2a-b913-8798-e053-2a95a90ab4e6	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	b1cfc126-63f3-4ad9-e053-2a95a90a86cf	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	b1cfdb43-564d-3fd8-e053-2995a90a6806	2
581662	ethanol 70 % Topical Gel	SY	b1cf84af-7556-a9d0-e053-2a95a90adad9	2
581662	ethanol 70 % Topical Gel	SY	b1cfaa2a-b913-8798-e053-2a95a90ab4e6	2
581662	ethanol 70 % Topical Gel	SY	b1cfc126-63f3-4ad9-e053-2a95a90a86cf	2
581662	ethanol 70 % Topical Gel	SY	b1cfdb43-564d-3fd8-e053-2995a90a6806	2
581662	ethyl alcohol 70 % Topical Gel	SY	b1cf84af-7556-a9d0-e053-2a95a90adad9	2
581662	ethyl alcohol 70 % Topical Gel	SY	b1cfaa2a-b913-8798-e053-2a95a90ab4e6	2
581662	ethyl alcohol 70 % Topical Gel	SY	b1cfc126-63f3-4ad9-e053-2a95a90a86cf	2
581662	ethyl alcohol 70 % Topical Gel	SY	b1cfdb43-564d-3fd8-e053-2995a90a6806	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80869-420-01	80869042001	60 mL in 1 BOTTLE (80869-420-01)	60 ml	2020-03-30	0000-00-00	No	No	Current
80869-420-02	80869042002	250 mL in 1 BOTTLE (80869-420-02)	250 ml	2020-03-30	0000-00-00	No	No	Current
80869-420-03	80869042003	500 mL in 1 BOTTLE (80869-420-03)	500 ml	2020-03-30	0000-00-00	No	No	Current
80869-420-04	80869042004	4000 mL in 1 BOTTLE (80869-420-04)	4000 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - GMA Supplies LLC	GMA Supplies LLC	2020-12-16	HUMAN OTC DRUG LABEL	2
Hand Sanitizer - GMA Supplies LLC	GMA Supplies LLC	2020-12-16	HUMAN OTC DRUG LABEL	2
Hand Sanitizer - GMA Supplies LLC	GMA Supplies LLC	2020-12-16	HUMAN OTC DRUG LABEL	2
Hand Sanitizer - GMA Supplies LLC	GMA Supplies LLC	2020-12-16	HUMAN OTC DRUG LABEL	2