Hand Sanitizer

Product NDC: 75815-521
11-digit product format: 758150521
Labeler code: 75815
Product ID: 75815-521_a5771a01-4e1c-a874-e053-2a95a90a11a8
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: KB HPS
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-11
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75815-521		I	Inactivated by FDA	2026-10-05
excluded product	product	75815-521		I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-02	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-04	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-06	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-08	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-10	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-12	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-14	I	Inactivated by FDA	2026-10-05
excluded package	package	75815-521	75815-521-16	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 3 · 180 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 package	package	75815-521-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75815-521-14	`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 package	package	75815-521-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75815-521-14	`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 package	package	75815-521-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75815-521-14	`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 package	package	75815-521-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75815-521-14	`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 package	package	75815-521-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75815-521-14	`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 package	package	75815-521-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75815-521-14	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
75815-521-02	d6a99b39-716d-a426-e053-dadaa90af4c2	a51d014c-651c-19bf-e053-2995a90a3d79
75815-521-04	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-06	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-08	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-10	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-12	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-14	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7
75815-521-16	d6a99b39-56c5-a426-e053-dadaa90af4c2	a577322f-918f-7bb0-e053-2995a90a90e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75815-521-02	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-04	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-06	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-08	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-10	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-12	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-14	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1
75815-521-16	Hand Sanitizer	30000 mL in 1 BOTTLE, PUMP	GEL	30000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75815-521	HAND SANITIZER (ALCOHOL) GEL [KB HPS]	1	Legacy NDC, 1 package rows	20200509_a51d014c-651c-19bf-e053-2995a90a3d79.zip
75815-521	HAND SANITIZER (ALCOHOL) GEL [KB HPS]	1	Legacy NDC, 7 package rows	20200513_a577322f-918f-7bb0-e053-2995a90a90e7.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	a51d014c-651c-19bf-e053-2995a90a3d79	1
1041498	ethanol 80 % Topical Gel	PSN	a577322f-918f-7bb0-e053-2995a90a90e7	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a51d014c-651c-19bf-e053-2995a90a3d79	1
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a577322f-918f-7bb0-e053-2995a90a90e7	1
1041498	ethanol 80 % Topical Gel	SY	a51d014c-651c-19bf-e053-2995a90a3d79	1
1041498	ethanol 80 % Topical Gel	SY	a577322f-918f-7bb0-e053-2995a90a90e7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75815-521-02	75815052102	30000 mL in 1 BOTTLE, PUMP (75815-521-02)	30000 ml	2020-05-07	0000-00-00	No	No	Current
75815-521-04	75815052104	30000 mL in 1 BOTTLE, PUMP (75815-521-04)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-06	75815052106	30000 mL in 1 BOTTLE, PUMP (75815-521-06)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-08	75815052108	30000 mL in 1 BOTTLE, PUMP (75815-521-08)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-10	75815052110	30000 mL in 1 BOTTLE, PUMP (75815-521-10)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-12	75815052112	30000 mL in 1 BOTTLE, PUMP (75815-521-12)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-14	75815052114	30000 mL in 1 BOTTLE, PUMP (75815-521-14)	30000 ml	2020-05-11	0000-00-00	No	No	Current
75815-521-16	75815052116	30000 mL in 1 BOTTLE, PUMP (75815-521-16)	30000 ml	2020-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - KB HPS	KB HPS	2020-05-12	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - KB HPS	KB HPS	2020-05-08	HUMAN OTC DRUG LABEL	1