Gel Hand Sanitizer

Product NDC: 75816-275
11-digit product format: 758160275
Labeler code: 75816
Product ID: 75816-275_a3817e2d-a4ff-64bf-e053-2995a90a2fe8
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Classic Coatings Systems
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-04-20
Marketing end: 0000-00-00
Substance: ISOPROPYL ALCOHOL
Active strength: 75 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75816-275		I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-01	I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-05	I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-06	I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-27	I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-32	I	Inactivated by FDA	2026-10-12
excluded package	package	75816-275	75816-275-55	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 3 · 126 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	75816-275-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75816-275-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75816-275-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75816-275-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75816-275-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75816-275-55	`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	75816-275-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75816-275-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75816-275-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75816-275-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75816-275-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75816-275-55	`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	75816-275-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75816-275-27	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75816-275-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75816-275-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75816-275-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75816-275-55	`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	75816-275-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75816-275-27	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75816-275-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75816-275-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75816-275-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75816-275-55	`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	75816-275-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75816-275-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75816-275-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75816-275-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75816-275-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75816-275-55	`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	75816-275-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75816-275-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75816-275-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75816-275-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75816-275-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75816-275-55	`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	75816-275-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75816-275-27	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75816-275-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75816-275-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75816-275-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75816-275-55	`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	75816-275-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75816-275-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75816-275-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75816-275-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75816-275-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75816-275-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75816-275-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75816-275-27	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75816-275-32	`0efc9e666f02…`	`f202fb6c5f17…`

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, Related label table
NDC	Related label
75816-275-01	a38183fb-82e3-46df-e053-2995a90a41af
75816-275-05	a38183fb-82e3-46df-e053-2995a90a41af
75816-275-06	a38183fb-82e3-46df-e053-2995a90a41af
75816-275-27	a38183fb-82e3-46df-e053-2995a90a41af
75816-275-32	a38183fb-82e3-46df-e053-2995a90a41af
75816-275-55	a38183fb-82e3-46df-e053-2995a90a41af

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75816-275-01	Gel Hand Sanitizer	3785 mL in 1 JUG	GEL	3785	1
75816-275-05	Gel Hand Sanitizer	18927 mL in 1 PAIL	GEL	18927	1
75816-275-06	Gel Hand Sanitizer	177 mL in 1 BOTTLE, DISPENSING	GEL	177	1
75816-275-27	Gel Hand Sanitizer	1040988 mL in 1 CONTAINER	GEL	1040988	1
75816-275-32	Gel Hand Sanitizer	946 mL in 1 BOTTLE, DISPENSING	GEL	946	1
75816-275-55	Gel Hand Sanitizer	208198 mL in 1 DRUM	GEL	208198	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75816-275	GEL HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [CLASSIC COATINGS SYSTEMS]	1	Legacy NDC, 6 package rows	20200501_a38183fb-82e3-46df-e053-2995a90a41af.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2285607	isopropyl alcohol 75 % Topical Gel	PSN	a38183fb-82e3-46df-e053-2995a90a41af	1
2285607	isopropyl alcohol 0.75 ML/ML Topical Gel	SCD	a38183fb-82e3-46df-e053-2995a90a41af	1
2285607	isopropyl alcohol 75 % Topical Gel	SY	a38183fb-82e3-46df-e053-2995a90a41af	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75816-275-01	75816027501	3785 mL in 1 JUG (75816-275-01)	3785 ml	2020-04-20	0000-00-00	No	No	Current
75816-275-05	75816027505	18927 mL in 1 PAIL (75816-275-05)	18927 ml	2020-04-20	0000-00-00	No	No	Current
75816-275-06	75816027506	177 mL in 1 BOTTLE, DISPENSING (75816-275-06)	177 ml	2020-04-20	0000-00-00	No	No	Current
75816-275-27	75816027527	1040988 mL in 1 CONTAINER (75816-275-27)	1040988 ml	2020-04-20	0000-00-00	No	No	Current
75816-275-32	75816027532	946 mL in 1 BOTTLE, DISPENSING (75816-275-32)	946 ml	2020-04-20	0000-00-00	No	No	Current
75816-275-55	75816027555	208198 mL in 1 DRUM (75816-275-55)	208198 ml	2020-04-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gel Hand Sanitizer - Classic Coatings Systems	Classic Coatings Systems	2020-04-17	HUMAN OTC DRUG LABEL	1