Hand Sanitizer

Product NDC: 69964-0013
11-digit product format: 699640013
Labeler code: 69964
Product ID: 69964-0013_adafdc21-de0a-15f6-e053-2995a90a4584
Type: HUMAN OTC DRUG
Nonproprietary name: Hand Sanitizer
Dosage form: GEL
Route: TOPICAL
Labeler: XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-04-14
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 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	69964-0013		I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-1	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-2	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-3	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-4	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-5	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-6	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-7	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-8	I	Inactivated by FDA	2026-10-16
excluded package	package	69964-0013	69964-0013-9	I	Inactivated by FDA	2026-10-16

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 3 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
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	69964-0013-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-7	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69964-0013-3	`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	69964-0013-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-7	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-9	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-6	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69964-0013-3	`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	69964-0013-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-7	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-9	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-6	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69964-0013-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-7	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-8	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-4	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-9	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69964-0013-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-7	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-8	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-4	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-9	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69964-0013-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-5	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-7	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-8	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-1	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-4	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-9	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-2	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-6	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69964-0013-3	`bd6a592717d7…`	`303034d00443…`

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
69964-0013-1	69964-0013 Hand Sanitizer
69964-0013-2	69964-0013 Hand Sanitizer
69964-0013-3	69964-0013 Hand Sanitizer
69964-0013-4	69964-0013 Hand Sanitizer
69964-0013-5	69964-0013 Hand Sanitizer
69964-0013-6	69964-0013 Hand Sanitizer
69964-0013-7	69964-0013 Hand Sanitizer
69964-0013-8	69964-0013 Hand Sanitizer
69964-0013-9	69964-0013 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69964-0013-1	Hand Sanitizer	29.57 mL in 1 BOTTLE	GEL	29.57	2
69964-0013-2	Hand Sanitizer	29.57 mL in 1 BOTTLE	GEL	29.57	2
69964-0013-3	Hand Sanitizer	29.57 mL in 1 BOTTLE	GEL	29.57	2
69964-0013-4	Hand Sanitizer	29.57 mL in 1 BOTTLE	GEL	29.57	2
69964-0013-5	Hand Sanitizer	29.57 mL in 1 BOTTLE	GEL	29.57	2
69964-0013-6	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	2
69964-0013-7	Hand Sanitizer	100 mL in 1 BOTTLE	GEL	100	2
69964-0013-8	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	2
69964-0013-9	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69964-0013	HAND SANITIZER GEL [XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD]	2	Legacy NDC, 9 package rows	20200826_adaf7316-75a6-5417-e053-2995a90ad35b.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	adaf7316-75a6-5417-e053-2995a90ad35b	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	adaf7316-75a6-5417-e053-2995a90ad35b	2
581662	ethanol 70 % Topical Gel	SY	adaf7316-75a6-5417-e053-2995a90ad35b	2
581662	ethyl alcohol 70 % Topical Gel	SY	adaf7316-75a6-5417-e053-2995a90ad35b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69964-0013-1	69964001301	29.57 mL in 1 BOTTLE (69964-0013-1)	29.57 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-2	69964001302	29.57 mL in 1 BOTTLE (69964-0013-2)	29.57 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-3	69964001303	29.57 mL in 1 BOTTLE (69964-0013-3)	29.57 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-4	69964001304	29.57 mL in 1 BOTTLE (69964-0013-4)	29.57 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-5	69964001305	29.57 mL in 1 BOTTLE (69964-0013-5)	29.57 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-6	69964001306	60 mL in 1 BOTTLE (69964-0013-6)	60 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-7	69964001307	100 mL in 1 BOTTLE (69964-0013-7)	100 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-8	69964001308	250 mL in 1 BOTTLE (69964-0013-8)	250 ml	2020-04-14	0000-00-00	No	No	Current
69964-0013-9	69964001309	500 mL in 1 BOTTLE (69964-0013-9)	500 ml	2020-04-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
69964-0013 Hand Sanitizer	XIAMEN ROSEMARY BIOTECHNOLOGY CO.,LTD	2020-08-25	HUMAN OTC DRUG LABEL	2