HAND SANITIZING

Product NDC: 65365-002
11-digit product format: 653650002
Labeler code: 65365
Product ID: 65365-002_e4752d2c-1463-4940-93f8-6af8c91d2f60
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Sigan Industries
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 62 mg/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65365-002		I	Inactivated by FDA	2026-10-15
excluded package	package	65365-002	65365-002-01	I	Inactivated by FDA	2026-10-15
excluded package	package	65365-002	65365-002-02	I	Inactivated by FDA	2026-10-15
excluded package	package	65365-002	65365-002-03	I	Inactivated by FDA	2026-10-15

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 · 88 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	65365-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65365-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65365-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65365-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65365-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65365-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65365-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65365-002-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65365-002-01	`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 package	package	65365-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65365-002-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65365-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65365-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65365-002-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65365-002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65365-002-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65365-002-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65365-002-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65365-002-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65365-002-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65365-002-01	`367a005e9d99…`	`383a685ebd0f…`
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	65365-002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65365-002-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65365-002-01	`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	65365-002-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65365-002-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65365-002-01	`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	65365-002-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65365-002-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65365-002-01	`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	65365-002-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65365-002-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65365-002-01	`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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65365-002-01	2019-10-29	C162847	48780-1	960f7f55-d42d-8e05-e053-dbdaa90a074a	time & again™ HAND SANITIZING GEL MANDARIN
65365-002-02	2019-10-29	C162847	48780-1	960f7f55-d42d-8e05-e053-dbdaa90a074a	time & again™ HAND SANITIZING GEL MANDARIN
65365-002-03	2019-10-29	C162847	48780-1	960f7f55-d42d-8e05-e053-dbdaa90a074a	time & again™ HAND SANITIZING GEL MANDARIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65365-002-01	HAND SANITIZING MANDARIN	232 mL in 1 BOTTLE, PUMP	GEL	232	1
65365-002-02	HAND SANITIZING MANDARIN	59 mL in 1 BOTTLE	GEL	59	1
65365-002-03	HAND SANITIZING MANDARIN	15 mL in 1 BOTTLE	GEL	15	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
CHAMAEMELUM NOBILE FLOWER	INACTIVE INGREDIENT	O2T154T6OG	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
GLYCERYL COCOATE	INACTIVE INGREDIENT	WVK1CT5994	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
ROSEMARY	INACTIVE INGREDIENT	IJ67X351P9	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
SAGE	INACTIVE INGREDIENT	065C5D077J	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
URTICA DIOICA LEAF	INACTIVE INGREDIENT	X6M0DRN46Q	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65365-002	HAND SANITIZING (ALCOHOL) GEL [SIGAN INDUSTRIES]	1	Legacy NDC, 3 package rows	20110315_fd7c761f-9fc6-4929-88b8-a4474fb9ef24.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
581660	ethanol 62 % Topical Gel	PSN	fd7c761f-9fc6-4929-88b8-a4474fb9ef24	1
581660	ethanol 0.62 ML/ML Topical Gel	SCD	fd7c761f-9fc6-4929-88b8-a4474fb9ef24	1
581660	ethanol 62 % Topical Gel	SY	fd7c761f-9fc6-4929-88b8-a4474fb9ef24	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65365-002-01	65365000201	232 mL in 1 BOTTLE, PUMP	232 ml	Historical
65365-002-02	65365000202	59 mL in 1 BOTTLE	59 ml	Historical
65365-002-03	65365000203	15 mL in 1 BOTTLE	15 ml	Historical