Hand Sanitizer

Product NDC: 78763-101
11-digit product format: 787630101
Labeler code: 78763
Product ID: 78763-101_ae6a43c6-8a46-04e3-e053-2a95a90a8d84
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Lubdeco S.A. de C.V.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-20
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 700 mL/1000mL
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	78763-101		I	Inactivated by FDA	2026-10-05
excluded product	product	78763-101		I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-11	I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-14	I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78763-101	78763-101-99	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 · 144 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	78763-101-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78763-101-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78763-101-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78763-101-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78763-101-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78763-101-01	`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	78763-101-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78763-101-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78763-101-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78763-101-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78763-101-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78763-101-01	`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	78763-101-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78763-101-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78763-101-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78763-101-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78763-101-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78763-101-01	`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	78763-101-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78763-101-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78763-101-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78763-101-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78763-101-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78763-101-01	`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	78763-101-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78763-101-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78763-101-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78763-101-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78763-101-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78763-101-01	`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	78763-101-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78763-101-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78763-101-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78763-101-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78763-101-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78763-101-01	`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 package	package	78763-101-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78763-101-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78763-101-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78763-101-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78763-101-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78763-101-01	`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 package	package	78763-101-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78763-101-02	`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
78763-101-01	d6a99b39-94c9-a426-e053-dadaa90af4c2	Hand Sanitizer
78763-101-02	d6a99b39-43af-a426-e053-dadaa90af4c2	aaed2286-253c-44c9-e053-2995a90a3b19
78763-101-04	d6a99b39-94c9-a426-e053-dadaa90af4c2	Hand Sanitizer
78763-101-11	d6a99b39-43af-a426-e053-dadaa90af4c2	aaed2286-253c-44c9-e053-2995a90a3b19
78763-101-14	d6a99b39-43af-a426-e053-dadaa90af4c2	aaed2286-253c-44c9-e053-2995a90a3b19
78763-101-99	d6a99b39-94c9-a426-e053-dadaa90af4c2	Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78763-101-01	Hand Sanitizer	1 mL in 1 BOTTLE	LIQUID	1	2
78763-101-02	Hand Sanitizer	2.5 mL in 1 PACKET	LIQUID	2.5	2
78763-101-04	Hand Sanitizer	3.78 mL in 1 BOTTLE	LIQUID	3.78	2
78763-101-11	Hand Sanitizer	1000 mL in 1 BOTTLE	LIQUID	1000	2
78763-101-14	Hand Sanitizer	3780 mL in 1 BOTTLE	LIQUID	3780	2
78763-101-99	Hand Sanitizer	2.5 mL in 1 PACKET	LIQUID	2.5	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78763-101	HAND SANITIZER (ETHYL ALCOHOL) LIQUID [LUBDECO S.A. DE C.V.]	2	Legacy NDC, 3 package rows	20200721_aaed2286-253c-44c9-e053-2995a90a3b19.zip
78763-101	HAND SANITIZER (ETHYL ALCOHOL) LIQUID [LUBDECO S.A. DE C.V.]	2	Legacy NDC, 3 package rows	20200904_a73a8acd-057e-4fb5-e053-2995a90aaac9.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	a73a8acd-057e-4fb5-e053-2995a90aaac9	2
581662	ethanol 70 % Topical Gel	PSN	aaed2286-253c-44c9-e053-2995a90a3b19	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a73a8acd-057e-4fb5-e053-2995a90aaac9	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	aaed2286-253c-44c9-e053-2995a90a3b19	2
581662	ethanol 70 % Topical Gel	SY	a73a8acd-057e-4fb5-e053-2995a90aaac9	2
581662	ethanol 70 % Topical Gel	SY	aaed2286-253c-44c9-e053-2995a90a3b19	2
581662	ethyl alcohol 70 % Topical Gel	SY	a73a8acd-057e-4fb5-e053-2995a90aaac9	2
581662	ethyl alcohol 70 % Topical Gel	SY	aaed2286-253c-44c9-e053-2995a90a3b19	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78763-101-01	78763010101	1 mL in 1 BOTTLE (78763-101-01)	1 ml	2020-07-20	0000-00-00	No	No	Current
78763-101-02	78763010102	2.5 mL in 1 PACKET (78763-101-02)	2.5 ml	2020-07-20	0000-00-00	No	No	Current
78763-101-04	78763010104	3.78 mL in 1 BOTTLE (78763-101-04)	3.78 ml	2020-07-20	0000-00-00	No	No	Current
78763-101-11	78763010111	1000 mL in 1 BOTTLE (78763-101-11)	1000 ml	2020-07-20	0000-00-00	No	No	Current
78763-101-14	78763010114	3780 mL in 1 BOTTLE (78763-101-14)	3780 ml	2020-07-20	0000-00-00	No	No	Current
78763-101-99	78763010199	2.5 mL in 1 PACKET (78763-101-99)	2.5 ml	2020-07-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer	Lubdeco S.A. de C.V.	2020-09-03	HUMAN OTC DRUG LABEL	2
Hand Sanitizer - Lubdeco S.A. de C.V.	Lubdeco S.A. de C.V.	2020-07-21	HUMAN OTC DRUG LABEL	2