Instant Hand Sanitizer - Cocoa Butter

Product NDC: 57337-015
Requested package NDC: 57337-015-01
11-digit product format: 573370015
Labeler code: 57337
Product ID: 57337-015_126c057a-5b1c-c246-e063-6294a90a6936
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Rejoice International, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-07-05
Substance: ALCOHOL
Active strength: 147 mL/237mL
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: Instant Hand Sanitizer - Cocoa Butter
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	147 mL/237mL

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
97dee45e-53be-4b37-a427-fc24388c0e05	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-015-01	2024-02-28	C162847	48780-1	1030e365-1b40-111a-e063-dadaa90a10e2	Instant Hand Sanitizer - Cocoa Butter
57337-015-01	2024-01-30	C162847	48780-1	1030e365-1b40-111a-e063-dadaa90a10e2	Instant Hand Sanitizer - Cocoa Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-015-01	Instant Hand Sanitizer - Cocoa Butter	236 mL in 1 BOTTLE	GEL	236		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
CARBOMER HOMOPOLYMER TYPE B	INACTIVE INGREDIENT	HHT01ZNK31	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-015	INSTANT HAND SANITIZER - COCOA BUTTER (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240229_97dee45e-53be-4b37-a427-fc24388c0e05.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 107 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MyMedic Calendula Gel	CALENDULA OFFICINALIS FLOWER	Nantong Health & Beyond Hygienic Products Inc.	0f0aa235-ac35-ac91-e063-6394a90a73fc	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Oral Pain Relief Gel	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	0f0b6157-ec18-13ef-e063-6294a90a2e0c	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Super Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	0f0c535d-8ff3-4799-e063-6394a90a7063	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0f0d1ba7-fe9c-8e0b-e063-6394a90a3081	2024-01-16	Warnings	Exact identifier application number: M003
White Petrolatum	WHITE PETROLATUM	Nantong Health & Beyond Hygienic Products Inc.	0f0d6ff0-ff30-aaf8-e063-6394a90a2716	2024-01-16	Warnings	Exact identifier application number: M003
Thompson Hand Sanitizer	ETHYL ALCOHOL	Thompson	deada606-8a82-9eeb-e053-2a95a90a9e6d	2024-01-16	Warnings	Exact identifier application number: M003
MyMedic Arnica Gel	ARNICA MONTANA	Nantong Health & Beyond Hygienic Products Inc.	0ef8760d-27c0-7ece-e063-6294a90a6873	2024-01-15	Warnings	Exact identifier application number: M003
American Safety First Aid Antispetic	HYDROGEN PEROXIDE	Orazen Inc	ea2fbdfe-1932-9fb4-e053-2a95a90a3563	2024-01-15	Warnings	Exact identifier application number: M003
First Aid Antispetic	BENZALKONIUM CHLORIDE	Orazen Inc	ea2debcb-892c-339f-e053-2a95a90a4b18	2024-01-15	Warnings	Exact identifier application number: M003
Ever Ready First Aid	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Ever Ready First Aid	e53f3bf5-25c0-2b86-e053-2a95a90a010f	2024-01-15	Warnings	Exact identifier application number: M003
FIRST SHIELD First Aid Antiseptic	BENZALKONIUM CHLORIDE	Ever Ready First Aid	e013ef0a-ef3d-7af5-e053-2a95a90a54d3	2024-01-15	Warnings	Exact identifier application number: M003
Latalia Hand Sanitizer 80 Alcohol Antiseptic	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae55fab3-3177-383e-e053-2995a90a17a0	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipe	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD	ae564635-898e-fbf6-e053-2995a90a8119	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Sanitizing Wipes	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD	af850b5e-c99f-3d4e-e053-2995a90a7948	2024-01-10	Warnings	Exact identifier application number: M003
Latalia Alcohol Antiseptic 80 Sanitizing	ALCOHOL	INTERNATIONAL CONSUMER PRODUCTS (PVT) LTD	ba4b8fb3-09db-fa29-e053-2995a90a8617	2024-01-10	Warnings	Exact identifier application number: M003
Northside Hospital Amenity Kit--GI Dept	ALCOHOL	ASP Global, LLc	c284eba4-0b92-4981-b3f8-d8d99b58bdfd	2024-01-10	Warnings	Exact identifier application number: M003
Meijer 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Meijer, Inc.	33143d87-3e57-4a17-a96c-b699ad034b5b	2024-01-09	Warnings	Exact identifier application number: M003
Meijer 70 Isopropyl Alcohol Wipes First Aid Antiseptic	ISOPROPYL ALCOHOL	Meijer, Inc	2046162f-cb70-416c-ae37-14999883a807	2024-01-09	Warnings	Exact identifier application number: M003
Lightning X Antiseptic	BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	0e6b10e7-6e84-6bfc-e063-6294a90a8537	2024-01-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE 3.0%	Trifecta Pharmaceuticals USA, LLC.	e4e45f11-7cd4-e693-e053-2a95a90a4c34	2024-01-02	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	97dee45e-53be-4b37-a427-fc24388c0e05	3
581660	ethanol 0.62 ML/ML Topical Gel	SCD	97dee45e-53be-4b37-a427-fc24388c0e05	3
581660	ethanol 62 % Topical Gel	SY	97dee45e-53be-4b37-a427-fc24388c0e05	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-015-01	57337001501	236 mL in 1 BOTTLE (57337-015-01)	236 ml	2013-07-05	0000-00-00	No	No	Current

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