Hand Sanitizer

Product NDC: 78795-101
11-digit product format: 787950101
Labeler code: 78795
Product ID: 78795-101_d6694fb1-0f3f-6811-e053-2995a90ad485
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Platinum System Inc
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-26
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 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	78795-101		I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-14	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-21	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-45	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-50	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-69	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-76	I	Inactivated by FDA	2026-10-05
excluded package	package	78795-101	78795-101-83	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 package	package	78795-101-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-69	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78795-101-83	`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	78795-101-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-69	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78795-101-83	`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	78795-101-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-69	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-76	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78795-101-83	`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	78795-101-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-69	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-76	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78795-101-83	`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	78795-101-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-69	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-76	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78795-101-83	`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	78795-101-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-69	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-76	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78795-101-83	`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	78795-101-45	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-69	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-76	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78795-101-83	`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	78795-101-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78795-101-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78795-101-69	`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
78795-101-14	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-21	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-45	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-50	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-69	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-76	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts
78795-101-83	GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78795-101-14	Hand Sanitizer	150 mL in 1 TUBE	SOLUTION	150	2
78795-101-21	Hand Sanitizer	50 in 1 CARTON	SOLUTION	50	2
78795-101-21	Hand Sanitizer	3 mL in 1 PACKET	SOLUTION	3	2
78795-101-45	Hand Sanitizer	260 mL in 1 BOTTLE	SOLUTION	260	2
78795-101-50	Hand Sanitizer	50 mL in 1 TUBE	SOLUTION	50	2
78795-101-69	Hand Sanitizer	500 mL in 1 BOTTLE	SOLUTION	500	2
78795-101-76	Hand Sanitizer	1000 mL in 1 BOTTLE	SOLUTION	1000	2
78795-101-83	Hand Sanitizer	3780 mL in 1 BOTTLE	SOLUTION	3780	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78795-101	HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [PLATINUM SYSTEM INC]	2	Legacy NDC, 8 package rows	20220126_a62cc8dc-e3c4-19e1-e053-2a95a90a41a6.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	a62cc8dc-e3c4-19e1-e053-2a95a90a41a6	2
582753	ethanol 0.7 ML/ML Topical Solution	SCD	a62cc8dc-e3c4-19e1-e053-2a95a90a41a6	2
582753	ethanol 70 % Topical Solution	SY	a62cc8dc-e3c4-19e1-e053-2a95a90a41a6	2
582753	ethyl alcohol 70 % Topical Solution	SY	a62cc8dc-e3c4-19e1-e053-2a95a90a41a6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78795-101-14	78795010114	150 mL in 1 TUBE (78795-101-14)	150 ml	2020-06-26	0000-00-00	No	No	Current
78795-101-21	78795010121	50 PACKET in 1 CARTON (78795-101-21) > 3 mL in 1 PACKET	50 packet	2020-06-26	0000-00-00	No	No	Current
78795-101-45	78795010145	260 mL in 1 BOTTLE (78795-101-45)	260 ml	2020-06-26	0000-00-00	No	No	Current
78795-101-50	78795010150	50 mL in 1 TUBE (78795-101-50)	50 ml	2020-06-26	0000-00-00	No	No	Current
78795-101-69	78795010169	500 mL in 1 BOTTLE (78795-101-69)	500 ml	2020-06-26	0000-00-00	No	No	Current
78795-101-76	78795010176	1000 mL in 1 BOTTLE (78795-101-76)	1000 ml	2020-06-26	0000-00-00	No	No	Current
78795-101-83	78795010183	3780 mL in 1 BOTTLE (78795-101-83)	3780 ml	2020-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GelShop Hand Sanitizer (Alcohol Antiseptic 70%) Drug Facts	Platinum System Inc \| Les Entreprises Stefmar Inc	2022-01-25	HUMAN OTC DRUG LABEL	2