Kern Sani Hand Sanitizer

Product NDC: 77804-001
11-digit product format: 778040001
Labeler code: 77804
Product ID: 77804-001_8eb36da6-0b15-410f-b59a-f38064f6f019
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: KERN SANI, INC.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-16
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77804-001		I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-01	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-02	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-03	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-04	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-11	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-12	I	Inactivated by FDA	2026-10-16
excluded package	package	77804-001	77804-001-13	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 1 of 2 · 120 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	77804-001-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77804-001-01	`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	77804-001-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77804-001-01	`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	77804-001-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77804-001-01	`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	77804-001-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77804-001-01	`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	77804-001-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77804-001-01	`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	77804-001-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77804-001-01	`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	77804-001-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77804-001-01	`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	77804-001-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	77804-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	77804-001-13	`ed331223b511…`	`672a5bd82f5f…`

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
77804-001-01	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-02	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-03	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-04	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-11	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-12	ebf0d903-6796-4716-8bd9-d33d4db8b8d0
77804-001-13	ebf0d903-6796-4716-8bd9-d33d4db8b8d0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77804-001-01	Kern Sani Hand Sanitizer	118 mL in 1 BOTTLE, PUMP	SOLUTION	118	3
77804-001-02	Kern Sani Hand Sanitizer	236 mL in 1 BOTTLE, PUMP	SOLUTION	236	3
77804-001-03	Kern Sani Hand Sanitizer	473 mL in 1 BOTTLE, PUMP	SOLUTION	473	3
77804-001-04	Kern Sani Hand Sanitizer	946 mL in 1 BOTTLE, PUMP	SOLUTION	946	3
77804-001-11	Kern Sani Hand Sanitizer	3786 mL in 1 BOTTLE, PUMP	SOLUTION	3786	3
77804-001-12	Kern Sani Hand Sanitizer	18928 mL in 1 JUG	SOLUTION	18928	3
77804-001-13	Kern Sani Hand Sanitizer	189270 mL in 1 DRUM	SOLUTION	189270	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77804-001	KERN SANI HAND SANITIZER (ALCOHOL) SOLUTION [KERN SANI, INC.]	3	Legacy NDC, 7 package rows	20211106_ebf0d903-6796-4716-8bd9-d33d4db8b8d0.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
582753	ethanol 70 % Topical Solution	PSN	ebf0d903-6796-4716-8bd9-d33d4db8b8d0	3
582753	ethanol 0.7 ML/ML Topical Solution	SCD	ebf0d903-6796-4716-8bd9-d33d4db8b8d0	3
582753	ethanol 70 % Topical Solution	SY	ebf0d903-6796-4716-8bd9-d33d4db8b8d0	3
582753	ethyl alcohol 70 % Topical Solution	SY	ebf0d903-6796-4716-8bd9-d33d4db8b8d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77804-001-01	77804000101	118 mL in 1 BOTTLE, PUMP (77804-001-01)	118 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-02	77804000102	236 mL in 1 BOTTLE, PUMP (77804-001-02)	236 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-03	77804000103	473 mL in 1 BOTTLE, PUMP (77804-001-03)	473 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-04	77804000104	946 mL in 1 BOTTLE, PUMP (77804-001-04)	946 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-11	77804000111	3786 mL in 1 BOTTLE, PUMP (77804-001-11)	3786 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-12	77804000112	18928 mL in 1 JUG (77804-001-12)	18928 ml	2020-05-16	0000-00-00	No	No	Current
77804-001-13	77804000113	189270 mL in 1 DRUM (77804-001-13)	189270 ml	2020-05-16	0000-00-00	No	No	Current