LACTONE HAND SANITIZER

Product NDC: 75348-606
11-digit product format: 753480606
Labeler code: 75348
Product ID: 75348-606_aa7ebce0-afb0-5d9e-e053-2995a90ac42d
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 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 · 16 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75348-606		I	Inactivated by FDA	2026-10-05
excluded product	product	75348-606		I	Inactivated by FDA	2026-10-05
excluded product	product	75348-606		I	Inactivated by FDA	2026-10-05
excluded product	product	75348-606		I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-02	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-04	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-08	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-16	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-32	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-01	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-50	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-19	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-38	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-05	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-10	I	Inactivated by FDA	2026-10-05
excluded package	package	75348-606	75348-606-25	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 6 · 304 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75348-606-01	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75348-606-01	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75348-606-01	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75348-606-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
75348-606-01	c7ccaba7-181e-fd44-e053-dadaa90aa01b	Hand Sanitizer 606
75348-606-02	c7ccaba7-17ca-fd44-e053-dadaa90aa01b	Hand Sanitizer
75348-606-04	c7ccaba7-17ca-fd44-e053-dadaa90aa01b	Hand Sanitizer
75348-606-05	c7ccaba7-1374-fd44-e053-dadaa90aa01b	LACTONE HAND SANITIZER
75348-606-08	c7ccaba7-17ca-fd44-e053-dadaa90aa01b	Hand Sanitizer
75348-606-10	c7ccaba7-1374-fd44-e053-dadaa90aa01b	LACTONE HAND SANITIZER
75348-606-16	c7ccaba7-17ca-fd44-e053-dadaa90aa01b	Hand Sanitizer
75348-606-19	c7ccaba7-1101-fd44-e053-dadaa90aa01b	Hand sanitizer 606 gallon
75348-606-25	c7ccaba7-1374-fd44-e053-dadaa90aa01b	LACTONE HAND SANITIZER
75348-606-32	c7ccaba7-17ca-fd44-e053-dadaa90aa01b	Hand Sanitizer
75348-606-38	c7ccaba7-1101-fd44-e053-dadaa90aa01b	Hand sanitizer 606 gallon
75348-606-50	c7ccaba7-181e-fd44-e053-dadaa90aa01b	Hand Sanitizer 606

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75348-606-02	LACTONE HAND SANITIZER	59 mL in 1 BOTTLE, PLASTIC	GEL	59	7
75348-606-04	LACTONE HAND SANITIZER	118 mL in 1 BOTTLE, PLASTIC	GEL	118	7
75348-606-08	LACTONE HAND SANITIZER	236 mL in 1 BOTTLE, PLASTIC	GEL	236	7
75348-606-16	LACTONE HAND SANITIZER	473 mL in 1 BOTTLE, PLASTIC	GEL	473	7
75348-606-32	LACTONE HAND SANITIZER	946 mL in 1 BOTTLE, PLASTIC	GEL	946	7
75348-606-01	LACTONE HAND SANITIZER	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	1
75348-606-05	LACTONE HAND SANITIZER	50 mL in 1 BOTTLE	GEL	50	1
75348-606-10	LACTONE HAND SANITIZER	100 mL in 1 BOTTLE	GEL	100	1
75348-606-19	LACTONE HAND SANITIZER	19000 mL in 1 BOTTLE, PLASTIC	GEL	19000	1
75348-606-25	LACTONE HAND SANITIZER	250 mL in 1 BOTTLE	GEL	250	1
75348-606-38	LACTONE HAND SANITIZER	3800 mL in 1 BOTTLE, PLASTIC	GEL	3800	1
75348-606-50	LACTONE HAND SANITIZER	500 mL in 1 BOTTLE, PLASTIC	GEL	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75348-606	LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]	7	Legacy NDC, 5 package rows	20200607_a33959b4-3d50-290f-e053-2a95a90a460b.zip
75348-606	LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]	1	Legacy NDC, 2 package rows	20200715_aa74394e-f181-2ab5-e053-2995a90a6fef.zip
75348-606	LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]	1	Legacy NDC, 2 package rows	20200716_aa7ebce0-afbe-5d9e-e053-2995a90ac42d.zip
75348-606	LACTONE HAND SANITIZER (ALCOHOL) GEL [ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI]	1	Legacy NDC, 3 package rows	20200425_b996b2fb-59db-4435-8b21-f11baf6de491.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
1041498	ethanol 80 % Topical Gel	PSN	a33959b4-3d50-290f-e053-2a95a90a460b	7
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a33959b4-3d50-290f-e053-2a95a90a460b	7
1041498	ethanol 80 % Topical Gel	SY	a33959b4-3d50-290f-e053-2a95a90a460b	7
1041498	ethanol 80 % Topical Gel	PSN	aa74394e-f181-2ab5-e053-2995a90a6fef	1
1041498	ethanol 80 % Topical Gel	PSN	aa7ebce0-afbe-5d9e-e053-2995a90ac42d	1
1041498	ethanol 80 % Topical Gel	PSN	b996b2fb-59db-4435-8b21-f11baf6de491	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	aa74394e-f181-2ab5-e053-2995a90a6fef	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	aa7ebce0-afbe-5d9e-e053-2995a90ac42d	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	b996b2fb-59db-4435-8b21-f11baf6de491	1
1041498	ethanol 80 % Topical Gel	SY	aa74394e-f181-2ab5-e053-2995a90a6fef	1
1041498	ethanol 80 % Topical Gel	SY	aa7ebce0-afbe-5d9e-e053-2995a90ac42d	1
1041498	ethanol 80 % Topical Gel	SY	b996b2fb-59db-4435-8b21-f11baf6de491	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75348-606-01	75348060601	1000 mL in 1 BOTTLE, PLASTIC (75348-606-01)	1000 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-02	75348060602	59 mL in 1 BOTTLE, PLASTIC (75348-606-02)	59 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-04	75348060604	118 mL in 1 BOTTLE, PLASTIC (75348-606-04)	118 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-05	75348060605	50 mL in 1 BOTTLE (75348-606-05)	50 ml	2020-04-22	0000-00-00	No	No	Current
75348-606-08	75348060608	236 mL in 1 BOTTLE, PLASTIC (75348-606-08)	236 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-10	75348060610	100 mL in 1 BOTTLE (75348-606-10)	100 ml	2020-04-22	0000-00-00	No	No	Current
75348-606-16	75348060616	473 mL in 1 BOTTLE, PLASTIC (75348-606-16)	473 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-19	75348060619	19000 mL in 1 BOTTLE, PLASTIC (75348-606-19)	19000 ml	2020-03-30	0000-00-00	No	No	Current
75348-606-25	75348060625	250 mL in 1 BOTTLE (75348-606-25)	250 ml	2020-04-22	0000-00-00	No	No	Current
75348-606-32	75348060632	946 mL in 1 BOTTLE, PLASTIC (75348-606-32)	946 ml	2020-05-22	0000-00-00	No	No	Current
75348-606-38	75348060638	3800 mL in 1 BOTTLE, PLASTIC (75348-606-38)	3800 ml	2020-03-30	0000-00-00	No	No	Current
75348-606-50	75348060650	500 mL in 1 BOTTLE, PLASTIC (75348-606-50)	500 ml	2020-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer 606	ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI \| HARDAL GLOBAL CONSULTING LLC.	2020-07-15	HUMAN OTC DRUG LABEL	1
Hand sanitizer 606 gallon	ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI \| HARDAL GLOBAL CONSULTING LLC.	2020-07-15	HUMAN OTC DRUG LABEL	1
Hand Sanitizer	ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI \| HARDAL GLOBAL CONSULTING LLC.	2020-06-05	HUMAN OTC DRUG LABEL	7
LACTONE HAND SANITIZER	ALL ONE KOZMETIK SANAYI DIS TICARET ANONIM SIRKETI	2020-04-22	HUMAN OTC DRUG LABEL	1