Hand Sanitizer

Product NDC: 80135-001
11-digit product format: 801350001
Labeler code: 80135
Product ID: 80135-001_ad3ef011-effe-9d17-e053-2995a90a538f
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Tantum Lab SA de CV
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-08-19
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80135-001		I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-07	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-08	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-09	I	Inactivated by FDA	2026-10-05
excluded package	package	80135-001	80135-001-10	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 4 · 198 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	80135-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80135-001-07	`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	80135-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80135-001-07	`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	80135-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80135-001-07	`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	80135-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80135-001-07	`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	80135-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80135-001-07	`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	80135-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80135-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80135-001-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80135-001-10	`cdf11ea48f46…`	`ba0047e9e063…`

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
80135-001-01	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-02	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-03	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-04	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-05	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-06	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-07	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-08	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-09	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9
80135-001-10	ad3eec9b-5d55-53cd-e053-2a95a90a6ea9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80135-001-01	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1
80135-001-02	Hand Sanitizer	120 mL in 1 BOTTLE	GEL	120	1
80135-001-03	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	1
80135-001-04	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
80135-001-05	Hand Sanitizer	1000 mL in 1 BOTTLE	GEL	1000	1
80135-001-06	Hand Sanitizer	4000 mL in 1 BOTTLE	GEL	4000	1
80135-001-07	Hand Sanitizer	20000 mL in 1 DRUM	GEL	20000	1
80135-001-08	Hand Sanitizer	50000 mL in 1 DRUM	GEL	50000	1
80135-001-09	Hand Sanitizer	200000 mL in 1 DRUM	GEL	200000	1
80135-001-10	Hand Sanitizer	1000000 mL in 1 DRUM	GEL	1000000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80135-001	HAND SANITIZER (ALCOHOL) GEL [TANTUM LAB SA DE CV]	1	Legacy NDC, 10 package rows	20200820_ad3eec9b-5d55-53cd-e053-2a95a90a6ea9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80135-001-01	80135000101	60 mL in 1 BOTTLE (80135-001-01)	60 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-02	80135000102	120 mL in 1 BOTTLE (80135-001-02)	120 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-03	80135000103	250 mL in 1 BOTTLE (80135-001-03)	250 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-04	80135000104	500 mL in 1 BOTTLE (80135-001-04)	500 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-05	80135000105	1000 mL in 1 BOTTLE (80135-001-05)	1000 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-06	80135000106	4000 mL in 1 BOTTLE (80135-001-06)	4000 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-07	80135000107	20000 mL in 1 DRUM (80135-001-07)	20000 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-08	80135000108	50000 mL in 1 DRUM (80135-001-08)	50000 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-09	80135000109	200000 mL in 1 DRUM (80135-001-09)	200000 ml	2020-08-19	0000-00-00	No	No	Current
80135-001-10	80135000110	1000000 mL in 1 DRUM (80135-001-10)	1000000 ml	2020-08-19	0000-00-00	No	No	Current