XtraCare Hand Sanitizer

Product NDC: 57337-043
Requested package NDC: 57337-043-01
11-digit product format: 573370043
Labeler code: 57337
Product ID: 57337-043_126db003-135c-0ecb-e063-6394a90a1742
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-24
Substance: ALCOHOL
Active strength: 146 g/236g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: XtraCare Hand Sanitizer
Brand name suffix: Moisturize with Vitamin E
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	146 g/236g

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
13c99570-0859-4310-843a-5eb266698eb3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-043-01	2024-02-28	C162847	48780-1	1030e365-53fd-111a-e063-dadaa90a10e2	XtraCare Hand Sanitizer
57337-043-01	2024-01-30	C162847	48780-1	1030e365-53fd-111a-e063-dadaa90a10e2	XtraCare Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-043-01	XtraCare Hand SanitizerMoisturize with Vitamin E	236 g in 1 BOTTLE	GEL	236		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	71DD5V995L	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-043	XTRACARE HAND SANITIZER MOISTURIZE WITH VITAMIN E (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20240229_13c99570-0859-4310-843a-5eb266698eb3.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 106 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	a339dfd9-7cb8-4198-bc2a-9759648cf34e	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International	f15a90e2-4a1e-452a-b9ac-5eb6f7b3dc72	2024-02-28	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd	11ef87cc-6ff6-511b-e063-6294a90a662f	2024-02-21	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS 70% ETHYL ALCOHOL HAND SANITIZER	ETHYL ALCOHOL	MY IMPORTS USA LLC	11f19126-6abb-b14c-e063-6294a90a4e34	2024-02-21	Warnings	Exact identifier application number: M003
Antiseptic	ANTISEPTIC SPRAY	Dynarex Corporation	118192ac-7173-09c5-e063-6394a90ad550	2024-02-16	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL SPRAY	Dynarex Corporation	116e0c9c-cbe0-bf67-e063-6394a90ae530	2024-02-15	Warnings	Exact identifier application number: M003
POVIDONE-IODINE	POVIDONE-IODINE	HART Health	92b6a38e-c7bb-45e2-9c2a-7993ed1bac36	2024-02-15	Warnings	Exact identifier application number: M003
Povidone Iodine Gel Swabstick	POVIDONE IODINE GEL SWABSTICK	Dynarex Corporation	eb7e21be-521e-2d52-e053-2a95a90ade33	2024-02-13	Warnings	Exact identifier application number: M003
Antiseptic	ALCOHOL, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	71aeaf86-2b4d-4945-9606-a9db0ab6b726	2024-02-07	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE, BENZOCAINE	Safetec of America, Inc.	458e65f2-826d-4550-8c7d-17add2d7ba9a	2024-02-07	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Safetec of America, Inc.	a665e2ce-c7e1-4d79-aa58-da7595944e7f	2024-02-07	Warnings	Exact identifier application number: M003
First Aid and Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	47cb6921-5d82-4123-a9e0-0b05d4dcb5b2	2024-02-07	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbf0078-3660-fe5c-e063-6394a90afc2d	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc032af-26bc-0e8b-e063-6294a90a91b0	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 16.9oz with vitamin E	ETHYL ALCOHOL	Midwood Brands, LLC	0fc0bd79-ddd7-b9d1-e063-6394a90adc69	2024-01-25	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%V/V	Midwood Brands, LLC	0fc0970d-06a6-ade9-e063-6394a90ae7ff	2024-01-25	Warnings	Exact identifier application number: M003
Target Up and Up Pain Relieving Cleansing	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	TARGET CORPORATION	0f964747-be02-c715-e063-6294a90ad91e	2024-01-25	Warnings	Exact identifier application number: M003
SannyTize Hand Sanitizer	HAND SANITIZER	Dynarex Corporation	968713a5-64d3-86fc-e053-2995a90a088a	2024-01-24	Warnings	Exact identifier application number: M003
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	0fbd6962-59e6-7230-e063-6394a90afd8e	2024-01-24	Warnings	Exact identifier application number: M003
Cold Sore Treatment, 24-7 Life by 7-Eleven	BENZALKONIUM CHLORIDE	Lil' Drug Store Products, Inc.	0f4fb868-1462-f88e-e063-6394a90a69e4	2024-01-19	Warnings	Exact identifier application number: M003

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	13c99570-0859-4310-843a-5eb266698eb3	3
581660	ethanol 0.62 ML/ML Topical Gel	SCD	13c99570-0859-4310-843a-5eb266698eb3	3
581660	ethanol 62 % Topical Gel	SY	13c99570-0859-4310-843a-5eb266698eb3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-043-01	57337004301	236 g in 1 BOTTLE (57337-043-01)	236 g	2014-01-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Hand Sanitizer	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2024-02-28	HUMAN OTC DRUG LABEL	3