Hand Sanitizer

Product NDC: 71927-001
11-digit product format: 719270001
Labeler code: 71927
Product ID: 71927-001_3239e5cb-62d5-8f7c-e063-6294a90a336b
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Orazen Inc
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-07-15
Substance: ALCOHOL
Active strength: 62 mL/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	71927-001		I	Inactivated by FDA		2026-09-14
excluded package	package	71927-001	71927-001-01	I	Inactivated by FDA		2026-09-14

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 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71927-001-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71927-001-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-001-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71927-001-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-001-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71927-001-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-001-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71927-001-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-001-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71927-001-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-001-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71927-001-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-001-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71927-001-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-001-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71927-001-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Hand Sanitizer
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581660	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
aa846bb7-a64b-3358-e053-2995a90a9d09	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71927-001-02	2025-04-07	C162847	48780-1	2cef2736-86fe-d83d-e063-dadaa90ab31f	71927-001
71927-001-01	2025-01-30	C162847	48780-1	2cef2736-91d1-d83d-e063-dadaa90ab31f	600b618b-183a-18f6-e053-2a91aa0ae7ff
71927-001-02	2025-01-30	C162847	48780-1	2cef2736-86fe-d83d-e063-dadaa90ab31f	71927-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71927-001-02	Hand Sanitizer	30 mL in 1 BOTTLE, PLASTIC	GEL	30		2
71927-001-01	Hand Sanitizer	30 mL in 1 BOTTLE, PLASTIC	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71927-001	HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]	2	Current NDC, Legacy NDC, 1 package rows	20250409_aa846bb7-a64b-3358-e053-2995a90a9d09.zip
71927-001	HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC]	1	Current NDC, Legacy NDC, 1 package rows	20171211_600b618b-183a-18f6-e053-2a91aa0ae7ff.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 51 · 1,015 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Defense Antifungal Medicated Bar	TOLNAFTATE	Defense Soap LLC	812d78ea-a14a-e3a2-e053-2a91aa0a6ff5	2026-09-09	Warnings	Exact identifier application number: M005
Medline	MICONAZOLE NITRATE	Medline Industries, LP	0d997d1d-8663-201f-e063-6394a90a285e	2026-09-08	Warnings	Exact identifier application number: M005
Remedy Antifungal With Olivamine	MICONAZOLE NITRATE	Medline Industries, LP	28c5183e-05b4-1754-e054-00144ff8d46c	2026-09-08	Warnings	Exact identifier application number: M005
Claravie	MICONAZOLE NITRATE 2%	Gentell LLC	5afdc429-cb44-703c-e063-6294a90a971a	2026-09-08	Warnings	Exact identifier application number: M005
Inlifay ANTIFUNGAL	MICONAZOLE NITRATE 2% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a832f39-ac11-d8b3-e063-6394a90acb39	2026-09-06	Warnings	Exact identifier application number: M005
Noicaky FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5adcc5f7-2d47-2ad7-e063-6294a90a4848	2026-09-06	Warnings	Exact identifier application number: M005
LIFE66II ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5ab83796-0780-3b58-e063-6394a90a2e4e	2026-09-05	Warnings	Exact identifier application number: M005
FGPER Topical Antifungal Pen	UNDECYLENIC ACID	Guangzhou ChuanMa International Trading Co.,Ltd.	5abdcbff-6ab1-2f0a-e063-6294a90a57ef	2026-09-05	Warnings	Exact identifier application number: M005
Jock Itch Powder	MICONAZOLE NITRATE	Premier Brands of America Inc	5aaacc88-6752-ab47-e063-6394a90af7cd	2026-09-04	Warnings	Exact identifier application number: M005
ANTIFUNGAL BODY WASH	TOLNAFTATE	Guangzhou ChuanMa International Trading Co.,Ltd.	5a695043-f776-df5a-e063-6394a90ac274	2026-09-01	Warnings	Exact identifier application number: M005
KetoconClear Cream	KETOCONAZOLE	Guangzhou Shunfei Network Technology Co., Ltd.	5a54eebe-5b4a-28dd-e063-6294a90a607f	2026-08-31	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	InvaDerm Corporation	5a5cfed9-0587-7bef-e063-6294a90a64bf	2026-08-31	Warnings	Exact identifier application number: M005
Gembooxt RINGWORM Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	464a33c3-6d16-0cfd-e063-6294a90abf4b	2026-08-27	Warnings	Exact identifier application number: M005
DrAny NAIL FUNGUS TREATMENT	UNDECYLENIC ACID, TOLNAFTATE	Hong Kong Juxin Negosyo Kag Komersyo Co., Limited	59ef412b-fc7b-0a84-e063-6394a90abf25	2026-08-26	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	7fd4037e-d350-47b7-a7d9-a43b8e366fa0	2026-08-25	Warnings	Exact identifier application number: M005
WISH HAND SANITIZER pink dragon blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	593b3fbe-a8de-1c09-e063-6294a90adc69	2026-08-24	Warnings	Exact identifier application number: M005
Okkazhie WART REMOVER	40% SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	59c2d759-d1e9-6c9d-e063-6294a90a04db	2026-08-23	Warnings	Exact identifier application number: M005
1% ketoconazole anti dandruff	1% KETOCONAZOLE ANTI DANDRUFF SHAMPOO	Fast Sold LLC	7bb3598c-9597-4f3d-9a68-bd9565737928	2026-08-22	Warnings	Exact identifier application number: M005
JELVOXA ANTIFUNGAL	UNDECYLENIC ACID	Wuhan Ruihengjie Technology Co., Ltd.	59a2f16e-ef72-f1cb-e063-6394a90abb28	2026-08-22	Warnings	Exact identifier application number: M005
Viachs ANTIFUNGAL Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	598b7e0c-c76d-2f56-e063-6394a90a7053	2026-08-21	Warnings	Exact identifier application number: M005

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
581660	ethanol 62 % Topical Gel	PSN	aa846bb7-a64b-3358-e053-2995a90a9d09	2
581660	ethanol 0.62 ML/ML Topical Gel	SCD	aa846bb7-a64b-3358-e053-2995a90a9d09	2
581660	ethanol 62 % Topical Gel	SY	aa846bb7-a64b-3358-e053-2995a90a9d09	2
581660	ethanol 62 % Topical Gel	PSN	600b618b-183a-18f6-e053-2a91aa0ae7ff	1
581660	ethanol 0.62 ML/ML Topical Gel	SCD	600b618b-183a-18f6-e053-2a91aa0ae7ff	1
581660	ethanol 62 % Topical Gel	SY	600b618b-183a-18f6-e053-2a91aa0ae7ff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71927-001-01	71927000101	30 mL in 1 BOTTLE, PLASTIC (71927-001-01)	30 ml	2017-12-11	0000-00-00	No	No	Current
71927-001-02	71927000102	30 mL in 1 BOTTLE, PLASTIC (71927-001-02)	30 ml	2020-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
71927-001	Orazen Inc	2025-04-07	HUMAN OTC DRUG LABEL	2
Hand Sanitizer - Orazen Inc	Orazen Inc	2017-12-10	HUMAN OTC DRUG LABEL	1