Lemuel Hand Sanitizer

Product NDC: 78475-394
11-digit product format: 784750394
Labeler code: 78475
Product ID: 78475-394_cf82d9f0-66cf-2118-e053-2995a90a6750
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Laboratorios Lemuel SRL
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-17
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 mL/100mL
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	78475-394		I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-10	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-11	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-12	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-13	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-14	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-15	I	Inactivated by FDA	2026-10-12
excluded package	package	78475-394	78475-394-16	I	Inactivated by FDA	2026-10-12

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	78475-394-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78475-394-13	`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	78475-394-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78475-394-13	`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	78475-394-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78475-394-13	`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	78475-394-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78475-394-13	`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	78475-394-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78475-394-13	`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	78475-394-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78475-394-13	`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	78475-394-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78475-394-13	`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	78475-394-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78475-394-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78475-394-14	`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
78475-394-10	Hand Sanitizer
78475-394-11	Hand Sanitizer
78475-394-12	Hand Sanitizer
78475-394-13	Hand Sanitizer
78475-394-14	Hand Sanitizer
78475-394-15	Hand Sanitizer
78475-394-16	Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78475-394-10	Lemuel Hand Sanitizer	59.14 mL in 1 BOTTLE, PLASTIC	GEL	59.14	3
78475-394-11	Lemuel Hand Sanitizer	118.28 mL in 1 BOTTLE, PLASTIC	GEL	118.28	3
78475-394-12	Lemuel Hand Sanitizer	236.56 mL in 1 BOTTLE, PLASTIC	GEL	236.56	3
78475-394-13	Lemuel Hand Sanitizer	473.12 mL in 1 BOTTLE, PLASTIC	GEL	473.12	3
78475-394-14	Lemuel Hand Sanitizer	3786 mL in 1 BOTTLE, PLASTIC	GEL	3786	3
78475-394-15	Lemuel Hand Sanitizer	1893 mL in 1 BOTTLE, PLASTIC	GEL	1893	3
78475-394-16	Lemuel Hand Sanitizer	946.24 mL in 1 BOTTLE, PLASTIC	GEL	946.24	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78475-394	LEMUEL HAND SANITIZER (ALCOHOL) GEL [LABORATORIOS LEMUEL SRL]	3	Legacy NDC, 7 package rows	20211030_a72faeed-1f82-1918-e053-2a95a90a6b78.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	a72faeed-1f82-1918-e053-2a95a90a6b78	3
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a72faeed-1f82-1918-e053-2a95a90a6b78	3
1305100	ethanol 75 % Topical Gel	SY	a72faeed-1f82-1918-e053-2a95a90a6b78	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78475-394-10	78475039410	59.14 mL in 1 BOTTLE, PLASTIC (78475-394-10)	59.14 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-11	78475039411	118.28 mL in 1 BOTTLE, PLASTIC (78475-394-11)	118.28 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-12	78475039412	236.56 mL in 1 BOTTLE, PLASTIC (78475-394-12)	236.56 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-13	78475039413	473.12 mL in 1 BOTTLE, PLASTIC (78475-394-13)	473.12 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-14	78475039414	3786 mL in 1 BOTTLE, PLASTIC (78475-394-14)	3786 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-15	78475039415	1893 mL in 1 BOTTLE, PLASTIC (78475-394-15)	1893 ml	2020-06-17	0000-00-00	No	No	Current
78475-394-16	78475039416	946.24 mL in 1 BOTTLE, PLASTIC (78475-394-16)	946.24 ml	2020-06-17	0000-00-00	No	No	Current