Anti-Bacterial Hand Gel

Product NDC: 69358-0004
11-digit product format: 693580004
Labeler code: 69358
Product ID: 69358-0004_c1de95a1-c4b6-46ee-98c5-62d519198075
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: UniGroup Wholesale Inc.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-11-12
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 62 mL/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69358-0004		I	Inactivated by FDA		2026-10-16
excluded package	package	69358-0004	69358-0004-1	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 1 · 42 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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`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	69358-0004-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69358-0004-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69358-0004-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69358-0004-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69358-0004-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69358-0004-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69358-0004-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69358-0004-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69358-0004-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69358-0004-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69358-0004-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69358-0004-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69358-0004-1	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69358-0004-1	2020-01-31	C162847	48780-1	9d75b9cf-e2b8-f424-e053-dadaa90a57ce	82e93f71-84b0-4933-84e8-1fa532b9ddf6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69358-0004-1	Anti-Bacterial Hand Gel	29 mL in 1 BOTTLE, SPRAY	GEL	29		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Alcohol	ACTIVE INGREDIENT	3K9958V90M	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
Alcohol	ACTIVE MOIETY	3K9958V90M	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
ULTRAMARINE BLUE	INACTIVE INGREDIENT	I39WR998BI	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69358-0004	ANTI-BACTERIAL HAND GEL (ETHYL ALCOHOL) GEL [UNIGROUP WHOLESALE INC.]	1	Legacy NDC, 1 package rows	20141112_82e93f71-84b0-4933-84e8-1fa532b9ddf6.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
1020119	isopropyl alcohol 62 % Topical Gel	PSN	82e93f71-84b0-4933-84e8-1fa532b9ddf6	1
1020119	isopropyl alcohol 0.62 ML/ML Topical Gel	SCD	82e93f71-84b0-4933-84e8-1fa532b9ddf6	1
1020119	isopropyl alcohol 62 % Topical Gel	SY	82e93f71-84b0-4933-84e8-1fa532b9ddf6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69358-0004-1	69358000401	29 mL in 1 BOTTLE, SPRAY	29 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anti-Bacterial Hand Gel - UniGroup Wholesale Inc.	UniGroup Wholesale Inc.	2014-11-12	HUMAN OTC DRUG LABEL	1