Hand Sanitizer

Product NDC: 80806-421
11-digit product format: 808060421
Labeler code: 80806
Product ID: 80806-421_b3ecbdc0-86c0-819a-e053-2a95a90a4311
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Laavo Clean S.A. de C.V.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80806-421		I	Inactivated by FDA	2026-10-15
excluded product	product	80806-421		I	Inactivated by FDA	2026-10-15
excluded product	product	80806-421		I	Inactivated by FDA	2026-10-15
excluded product	product	80806-421		I	Inactivated by FDA	2026-10-15
excluded product	product	80806-421		I	Inactivated by FDA	2026-10-15
excluded package	package	80806-421	80806-421-03	I	Inactivated by FDA	2026-10-15
excluded package	package	80806-421	80806-421-05	I	Inactivated by FDA	2026-10-15
excluded package	package	80806-421	80806-421-07	I	Inactivated by FDA	2026-10-15
excluded package	package	80806-421	80806-421-09	I	Inactivated by FDA	2026-10-15
excluded package	package	80806-421	80806-421-11	I	Inactivated by FDA	2026-10-15

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 2 of 3 · 180 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
2025-02-02 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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80806-421-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80806-421-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80806-421-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80806-421-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	80806-421-05	`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…`
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	80806-421-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80806-421-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80806-421-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80806-421-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80806-421-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80806-421-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80806-421-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80806-421-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80806-421-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80806-421-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80806-421-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80806-421-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80806-421-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80806-421-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	80806-421-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80806-421-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80806-421-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80806-421-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80806-421-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	80806-421-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80806-421-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80806-421-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80806-421-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80806-421-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	80806-421-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
80806-421-03	d6a99b39-656d-a426-e053-dadaa90af4c2	b3e0eb97-bad4-4953-e053-2995a90a571b
80806-421-05	d6a99b39-ff63-a426-e053-dadaa90af4c2	b3eca691-b26b-24a4-e053-2995a90ad0a6
80806-421-07	d6a99b39-4ad1-a426-e053-dadaa90af4c2	b3ecada5-37ec-13f7-e053-2995a90aac50
80806-421-09	d6a99b39-b3c1-a426-e053-dadaa90af4c2	b3ecd002-e0e0-8198-e053-2a95a90a6a43
80806-421-11	d6a99b39-659a-a426-e053-dadaa90af4c2	b3ef5c99-915f-25d9-e053-2a95a90ab864

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80806-421-03	Hand Sanitizer	125 mL in 1 BOTTLE	GEL	125	1
80806-421-05	Hand Sanitizer	750 mL in 1 BOTTLE	GEL	750	1
80806-421-07	Hand Sanitizer	3780 mL in 1 BOTTLE	GEL	3780	1
80806-421-09	Hand Sanitizer	20000 mL in 1 CONTAINER	GEL	20000	1
80806-421-11	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80806-421	HAND SANITIZER (ALCOHOL) GEL [LAAVO CLEAN S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20201113_b3eca691-b26b-24a4-e053-2995a90ad0a6.zip
80806-421	HAND SANITIZER (ALCOHOL) GEL [LAAVO CLEAN S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20201113_b3ecd002-e0e0-8198-e053-2a95a90a6a43.zip
80806-421	HAND SANITIZER (ALCOHOL) GEL [LAAVO CLEAN S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20201113_b3ef5c99-915f-25d9-e053-2a95a90ab864.zip
80806-421	HAND SANITIZER (ALCOHOL) GEL [LAAVO CLEAN S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20201113_b3e0eb97-bad4-4953-e053-2995a90a571b.zip
80806-421	HAND SANITIZER (ALCOHOL) GEL [LAAVO CLEAN S.A. DE C.V.]	1	Legacy NDC, 1 package rows	20201113_b3ecada5-37ec-13f7-e053-2995a90aac50.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	b3e0eb97-bad4-4953-e053-2995a90a571b	1
1041498	ethanol 80 % Topical Gel	PSN	b3eca691-b26b-24a4-e053-2995a90ad0a6	1
1041498	ethanol 80 % Topical Gel	PSN	b3ecada5-37ec-13f7-e053-2995a90aac50	1
1041498	ethanol 80 % Topical Gel	PSN	b3ecd002-e0e0-8198-e053-2a95a90a6a43	1
1041498	ethanol 80 % Topical Gel	PSN	b3ef5c99-915f-25d9-e053-2a95a90ab864	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b3e0eb97-bad4-4953-e053-2995a90a571b	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b3eca691-b26b-24a4-e053-2995a90ad0a6	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b3ecada5-37ec-13f7-e053-2995a90aac50	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b3ecd002-e0e0-8198-e053-2a95a90a6a43	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b3ef5c99-915f-25d9-e053-2a95a90ab864	1
1041498	ethanol 80 % Topical Gel	SY	b3e0eb97-bad4-4953-e053-2995a90a571b	1
1041498	ethanol 80 % Topical Gel	SY	b3eca691-b26b-24a4-e053-2995a90ad0a6	1
1041498	ethanol 80 % Topical Gel	SY	b3ecada5-37ec-13f7-e053-2995a90aac50	1
1041498	ethanol 80 % Topical Gel	SY	b3ecd002-e0e0-8198-e053-2a95a90a6a43	1
1041498	ethanol 80 % Topical Gel	SY	b3ef5c99-915f-25d9-e053-2a95a90ab864	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80806-421-03	80806042103	125 mL in 1 BOTTLE (80806-421-03)	125 ml	2020-03-30	0000-00-00	No	No	Current
80806-421-05	80806042105	750 mL in 1 BOTTLE (80806-421-05)	750 ml	2020-03-30	0000-00-00	No	No	Current
80806-421-07	80806042107	3780 mL in 1 BOTTLE (80806-421-07)	3780 ml	2020-03-30	0000-00-00	No	No	Current
80806-421-09	80806042109	20000 mL in 1 CONTAINER (80806-421-09)	20000 ml	2020-03-30	0000-00-00	No	No	Current
80806-421-11	80806042111	60 mL in 1 BOTTLE (80806-421-11)	60 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - Laavo Clean S.A. de C.V.	Laavo Clean S.A. de C.V.	2020-11-12	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Laavo Clean S.A. de C.V.	Laavo Clean S.A. de C.V.	2020-11-12	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Laavo Clean S.A. de C.V.	Laavo Clean S.A. de C.V.	2020-11-12	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Laavo Clean S.A. de C.V.	Laavo Clean S.A. de C.V.	2020-11-12	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Laavo Clean S.A. de C.V.	Laavo Clean S.A. de C.V.	2020-11-11	HUMAN OTC DRUG LABEL	1