Sani-Kure Extra Strength Hand Sanitizer

Product NDC: 78923-001
11-digit product format: 789230001
Labeler code: 78923
Product ID: 78923-001_d5f4878d-f211-a454-e053-2995a90a700b
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: KOLORCURE CORPORATION
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-30
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 74 mL/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	78923-001		I	Inactivated by FDA	2026-10-05
excluded product	product	78923-001		I	Inactivated by FDA	2026-10-05
excluded product	product	78923-001		I	Inactivated by FDA	2026-10-05
excluded package	package	78923-001	78923-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78923-001	78923-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78923-001	78923-001-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78923-001	78923-001-32	I	Inactivated by FDA	2026-10-05
excluded package	package	78923-001	78923-001-38	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 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 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	78923-001-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78923-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78923-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78923-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78923-001-32	`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 package	package	78923-001-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78923-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78923-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78923-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78923-001-32	`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 package	package	78923-001-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78923-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78923-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78923-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78923-001-32	`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 package	package	78923-001-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78923-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78923-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78923-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78923-001-32	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	78923-001-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78923-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78923-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78923-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78923-001-32	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
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	78923-001-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78923-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78923-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78923-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78923-001-32	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
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	78923-001-38	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78923-001-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78923-001-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78923-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78923-001-32	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
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	78923-001-38	`ed331223b511…`	`672a5bd82f5f…`

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
78923-001-02	0191ceaa-6cca-198a-e063-dbdaa90aec3e	a7c04185-d309-931b-e053-2a95a90ac783
78923-001-04	0191ceaa-6884-198a-e063-dbdaa90aec3e	a932b278-ee8a-c37a-e053-2995a90aa2a1
78923-001-08	0191ceaa-6884-198a-e063-dbdaa90aec3e	a932b278-ee8a-c37a-e053-2995a90aa2a1
78923-001-32	0191ceaa-6afb-198a-e063-dbdaa90aec3e	ab65d627-2c5a-b64e-e053-2a95a90a335d
78923-001-38	0191ceaa-6afb-198a-e063-dbdaa90aec3e	ab65d627-2c5a-b64e-e053-2a95a90a335d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78923-001-32	Sani-Kure Extra Strength Hand Sanitizer	946 mL in 1 BOTTLE, SPRAY	SOLUTION	946	3
78923-001-38	Sani-Kure Extra Strength Hand Sanitizer	3800 mL in 1 BOTTLE, SPRAY	SOLUTION	3800	3
78923-001-02	Sani-Kure Extra Strength Hand Sanitizer	59 mL in 1 BOTTLE, SPRAY	SOLUTION	59	2
78923-001-04	Sani-Kure Extra Strength Hand Sanitizer	118 mL in 1 BOTTLE, SPRAY	SOLUTION	118	2
78923-001-08	Sani-Kure Extra Strength Hand Sanitizer	236 mL in 1 BOTTLE, SPRAY	SOLUTION	236	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78923-001	SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]	3	Legacy NDC, 2 package rows	20220120_ab65d627-2c5a-b64e-e053-2a95a90a335d.zip
78923-001	SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]	2	Legacy NDC, 1 package rows	20220120_a7c04185-d309-931b-e053-2a95a90ac783.zip
78923-001	SANI-KURE EXTRA STRENGTH HAND SANITIZER (ALCOHOL) SOLUTION [KOLORCURE CORPORATION]	2	Legacy NDC, 2 package rows	20220120_a932b278-ee8a-c37a-e053-2995a90aa2a1.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
78923-001-02	78923000102	59 mL in 1 BOTTLE, SPRAY (78923-001-02)	59 ml	2020-03-30	0000-00-00	No	No	Current
78923-001-04	78923000104	118 mL in 1 BOTTLE, SPRAY (78923-001-04)	118 ml	2020-03-30	0000-00-00	No	No	Current
78923-001-08	78923000108	236 mL in 1 BOTTLE, SPRAY (78923-001-08)	236 ml	2020-03-30	0000-00-00	No	No	Current
78923-001-32	78923000132	946 mL in 1 BOTTLE, SPRAY (78923-001-32)	946 ml	2020-03-30	0000-00-00	No	No	Current
78923-001-38	78923000138	3800 mL in 1 BOTTLE, SPRAY (78923-001-38)	3800 ml	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sani-Kure Extra Strength Hand Sanitizer - KOLORCURE CORPORATION	KOLORCURE CORPORATION	2022-01-19	HUMAN OTC DRUG LABEL	3
Sani-Kure Extra Strength Hand Sanitizer - KOLORCURE CORPORATION	KOLORCURE CORPORATION	2022-01-19	HUMAN OTC DRUG LABEL	2
Sani-Kure Extra Strength Hand Sanitizer - KOLORCURE CORPORATION	KOLORCURE CORPORATION	2022-01-19	HUMAN OTC DRUG LABEL	2