ServClean Gel Hand Sanitizer

Product NDC: 64646-380
11-digit product format: 646460380
Labeler code: 64646
Product ID: 64646-380_caf4e3a9-6cb5-a776-e053-2a95a90aee1b
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64646-380		I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-02	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-03	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-04	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-12	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-20	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-21	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-22	I	Inactivated by FDA	2026-10-05
excluded package	package	64646-380	64646-380-23	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 1 · 36 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
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	64646-380-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64646-380-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-21	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64646-380-22	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-23	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-21	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64646-380-22	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-23	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-21	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64646-380-22	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
64646-380-02	2024-07-22	SC Gel Hand Sanitizer
64646-380-03	2024-07-22	SC Gel Hand Sanitizer
64646-380-04	2024-07-22	SC Gel Hand Sanitizer
64646-380-12	2024-07-22	SC Gel Hand Sanitizer
64646-380-20	2024-07-22	SC Gel Hand Sanitizer
64646-380-21	2024-07-22	SC Gel Hand Sanitizer
64646-380-22	2024-07-22	SC Gel Hand Sanitizer
64646-380-23	2024-07-22	SC Gel Hand Sanitizer
64646-380-02	2023-01-30	SC Gel Hand Sanitizer
64646-380-03	2023-01-30	SC Gel Hand Sanitizer
64646-380-04	2023-01-30	SC Gel Hand Sanitizer
64646-380-12	2023-01-30	SC Gel Hand Sanitizer
64646-380-20	2023-01-30	SC Gel Hand Sanitizer
64646-380-21	2023-01-30	SC Gel Hand Sanitizer
64646-380-22	2023-01-30	SC Gel Hand Sanitizer
64646-380-23	2023-01-30	SC Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64646-380-02	ServClean Gel Hand Sanitizer	2000 mL in 1 BOTTLE	GEL	2000	2
64646-380-03	ServClean Gel Hand Sanitizer	3780 mL in 1 BOTTLE	GEL	3780	2
64646-380-04	ServClean Gel Hand Sanitizer	1250 mL in 1 BOTTLE, DISPENSING	GEL	1250	2
64646-380-12	ServClean Gel Hand Sanitizer	500 mL in 1 BOTTLE, PUMP	GEL	500	2
64646-380-20	ServClean Gel Hand Sanitizer	18900 mL in 1 PAIL	GEL	18900	2
64646-380-21	ServClean Gel Hand Sanitizer	55000 mL in 1 DRUM	GEL	55000	2
64646-380-22	ServClean Gel Hand Sanitizer	208000 mL in 1 DRUM	GEL	208000	2
64646-380-23	ServClean Gel Hand Sanitizer	1000000 mL in 1 DRUM	GEL	1000000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64646-380	SERVCLEAN GEL HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]	2	Legacy NDC, 8 package rows	20240724_caf4dba6-db03-2a91-e053-2995a90a8d69.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	caf4dba6-db03-2a91-e053-2995a90a8d69	2
2282911	ethanol 0.71 ML/ML Topical Gel	SCD	caf4dba6-db03-2a91-e053-2995a90a8d69	2
2282911	ethanol 71 % Topical Gel	SY	caf4dba6-db03-2a91-e053-2995a90a8d69	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64646-380-02	64646038002	2000 mL in 1 BOTTLE (64646-380-02)	2000 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-03	64646038003	3780 mL in 1 BOTTLE (64646-380-03)	3780 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-04	64646038004	1250 mL in 1 BOTTLE, DISPENSING (64646-380-04)	1250 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-12	64646038012	500 mL in 1 BOTTLE, PUMP (64646-380-12)	500 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-20	64646038020	18900 mL in 1 PAIL (64646-380-20)	18900 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-21	64646038021	55000 mL in 1 DRUM (64646-380-21)	55000 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-22	64646038022	208000 mL in 1 DRUM (64646-380-22)	208000 ml	2021-09-10	0000-00-00	No	No	Current
64646-380-23	64646038023	1000000 mL in 1 DRUM (64646-380-23)	1000000 ml	2021-09-10	0000-00-00	No	No	Current