ANTISEPTIC HAND SANITIZER

Product NDC: 78433-101
11-digit product format: 784330101
Labeler code: 78433
Product ID: 78433-101_a981dc46-3c36-4f3d-80a9-691747e50800
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-07
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 · 13 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78433-101		I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-01	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-02	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-03	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-04	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-05	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-06	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-07	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-08	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-09	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-10	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-11	I	Inactivated by FDA	2026-10-12
excluded package	package	78433-101	78433-101-12	I	Inactivated by FDA	2026-10-12

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 5 · 247 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	78433-101-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78433-101-02	`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	78433-101-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78433-101-02	`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	78433-101-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78433-101-02	`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	78433-101-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78433-101-02	`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	78433-101-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78433-101-04	`cfe11265f3b6…`	`090c488252e2…`

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
78433-101-01	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-02	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-03	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-04	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-05	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-06	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-07	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-08	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-09	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-10	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-11	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL
78433-101-12	WIEBERR ® ANTISEPTIC HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78433-101-01	ANTISEPTIC HAND SANITIZER	5 mL in 1 BOTTLE	GEL	5	1
78433-101-02	ANTISEPTIC HAND SANITIZER	10 mL in 1 BOTTLE	GEL	10	1
78433-101-03	ANTISEPTIC HAND SANITIZER	50 mL in 1 BOTTLE	GEL	50	1
78433-101-04	ANTISEPTIC HAND SANITIZER	100 mL in 1 BOTTLE	GEL	100	1
78433-101-05	ANTISEPTIC HAND SANITIZER	200 mL in 1 BOTTLE	GEL	200	1
78433-101-06	ANTISEPTIC HAND SANITIZER	250 mL in 1 BOTTLE	GEL	250	1
78433-101-07	ANTISEPTIC HAND SANITIZER	500 mL in 1 BOTTLE	GEL	500	1
78433-101-08	ANTISEPTIC HAND SANITIZER	750 mL in 1 BOTTLE	GEL	750	1
78433-101-09	ANTISEPTIC HAND SANITIZER	1000 mL in 1 BOTTLE	GEL	1000	1
78433-101-10	ANTISEPTIC HAND SANITIZER	5000 mL in 1 BOTTLE	GEL	5000	1
78433-101-11	ANTISEPTIC HAND SANITIZER	20000 mL in 1 CONTAINER	GEL	20000	1
78433-101-12	ANTISEPTIC HAND SANITIZER	1000000 mL in 1 CONTAINER	GEL	1000000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78433-101	ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI]	1	Legacy NDC, 12 package rows	20200717_173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d.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	173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d	1
581662	ethanol 70 % Topical Gel	SY	173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d	1
581662	ethyl alcohol 70 % Topical Gel	SY	173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78433-101-01	78433010101	5 mL in 1 BOTTLE (78433-101-01)	5 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-02	78433010102	10 mL in 1 BOTTLE (78433-101-02)	10 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-03	78433010103	50 mL in 1 BOTTLE (78433-101-03)	50 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-04	78433010104	100 mL in 1 BOTTLE (78433-101-04)	100 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-05	78433010105	200 mL in 1 BOTTLE (78433-101-05)	200 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-06	78433010106	250 mL in 1 BOTTLE (78433-101-06)	250 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-07	78433010107	500 mL in 1 BOTTLE (78433-101-07)	500 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-08	78433010108	750 mL in 1 BOTTLE (78433-101-08)	750 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-09	78433010109	1000 mL in 1 BOTTLE (78433-101-09)	1000 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-10	78433010110	5000 mL in 1 BOTTLE (78433-101-10)	5000 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-11	78433010111	20000 mL in 1 CONTAINER (78433-101-11)	20000 ml	2020-07-07	0000-00-00	No	No	Current
78433-101-12	78433010112	1000000 mL in 1 CONTAINER (78433-101-12)	1000000 ml	2020-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WIEBERR ® ANTISEPTIC HAND SANITIZER GEL	KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI	2020-07-07	HUMAN OTC DRUG LABEL	1