Hand Sanitizer

Product NDC: 64646-043
11-digit product format: 646460043
Labeler code: 64646
Product ID: 64646-043_cb097d2d-bdf0-5939-e053-2995a90afca8
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Charlotte Products Ltd.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-09-10
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 71 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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64646-043		I	Inactivated by FDA	2026-09-14
excluded product	product	64646-043		I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-73	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-02	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-03	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-04	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-12	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-20	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-21	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-22	I	Inactivated by FDA	2026-09-14
excluded package	package	64646-043	64646-043-23	I	Inactivated by FDA	2026-09-14

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 · 135 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	64646-043-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-22	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64646-043-21	`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	64646-043-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-22	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64646-043-21	`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	64646-043-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-22	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64646-043-21	`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	64646-043-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-22	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64646-043-21	`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	64646-043-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-22	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64646-043-21	`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	64646-043-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-22	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64646-043-21	`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	64646-043-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64646-043-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64646-043-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64646-043-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64646-043-23	`302b2466d912…`	`e7b80fea0513…`

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
64646-043-02	Enviro Solutions Gel Hand Sanitizer
64646-043-03	Enviro Solutions Gel Hand Sanitizer
64646-043-04	Enviro Solutions Gel Hand Sanitizer
64646-043-12	Enviro Solutions Gel Hand Sanitizer
64646-043-20	Enviro Solutions Gel Hand Sanitizer
64646-043-21	Enviro Solutions Gel Hand Sanitizer
64646-043-22	Enviro Solutions Gel Hand Sanitizer
64646-043-23	Enviro Solutions Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64646-043-73	Hand Sanitizer	1000 mL in 1 BOTTLE, DISPENSING	GEL	1000	2
64646-043-02	Hand Sanitizer	2000 mL in 1 BOTTLE	GEL	2000	1
64646-043-03	Hand Sanitizer	37800 mL in 1 BOTTLE	GEL	37800	1
64646-043-04	Hand Sanitizer	1250 mL in 1 BOTTLE, DISPENSING	GEL	1250	1
64646-043-12	Hand Sanitizer	500 mL in 1 BOTTLE, PUMP	GEL	500	1
64646-043-20	Hand Sanitizer	18900 mL in 1 PAIL	GEL	18900	1
64646-043-21	Hand Sanitizer	55000 mL in 1 DRUM	GEL	55000	1
64646-043-22	Hand Sanitizer	208000 mL in 1 DRUM	GEL	208000	1
64646-043-23	Hand Sanitizer	1000 mL in 1 DRUM	GEL	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64646-043	HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]	2	Legacy NDC, 1 package rows	20240202_fa5428f3-1516-d51e-e053-6294a90ad3f8.zip
64646-043	HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]	1	Legacy NDC, 8 package rows	20210911_cb09877c-fb37-394c-e053-2995a90a15d8.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
2282911	ethanol 71 % Topical Gel	PSN	fa5428f3-1516-d51e-e053-6294a90ad3f8	2
2282911	ethanol 0.71 ML/ML Topical Gel	SCD	fa5428f3-1516-d51e-e053-6294a90ad3f8	2
2282911	ethanol 71 % Topical Gel	SY	fa5428f3-1516-d51e-e053-6294a90ad3f8	2
2282911	ethanol 71 % Topical Gel	PSN	cb09877c-fb37-394c-e053-2995a90a15d8	1
2282911	ethanol 0.71 ML/ML Topical Gel	SCD	cb09877c-fb37-394c-e053-2995a90a15d8	1
2282911	ethanol 71 % Topical Gel	SY	cb09877c-fb37-394c-e053-2995a90a15d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64646-043-02	64646004302	2000 mL in 1 BOTTLE (64646-043-02)	2000 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-03	64646004303	37800 mL in 1 BOTTLE (64646-043-03)	37800 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-04	64646004304	1250 mL in 1 BOTTLE, DISPENSING (64646-043-04)	1250 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-12	64646004312	500 mL in 1 BOTTLE, PUMP (64646-043-12)	500 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-20	64646004320	18900 mL in 1 PAIL (64646-043-20)	18900 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-21	64646004321	55000 mL in 1 DRUM (64646-043-21)	55000 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-22	64646004322	208000 mL in 1 DRUM (64646-043-22)	208000 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-23	64646004323	1000 mL in 1 DRUM (64646-043-23)	1000 ml	2021-09-10	0000-00-00	No	No	Current
64646-043-73	64646004373	1000 mL in 1 BOTTLE, DISPENSING	1000 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Greven Gel Hand Sanitizer	Charlotte Products Ltd.	2024-02-01	HUMAN OTC DRUG LABEL	2
Enviro Solutions Gel Hand Sanitizer	Charlotte Products Ltd.	2021-09-02	HUMAN OTC DRUG LABEL	1