XtraCare Warm Vanilla

Product NDC: 57337-074
11-digit product format: 573370074
Labeler code: 57337
Product ID: 57337-074_2ded3cc6-b007-cea0-e063-6394a90aff4b
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: 2015-02-17
Substance: ALCOHOL
Active strength: 62 g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 6 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
2025-02-02 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	57337-074-01	`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	57337-074-01	`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	57337-074-01	`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: XtraCare Warm Vanilla
Listing expiration: 2027-12-31

Active Ingredients#

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

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
46e7b4fa-3722-4487-9325-f8552ea92acf	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57337-074-01	2025-02-12	C162847	48780-1	2cef2736-96cb-d83d-e063-dadaa90ab31f	XtraCare Warm Vanilla
57337-074-01	2025-01-30	C162847	48780-1	2cef2736-96cb-d83d-e063-dadaa90ab31f	XtraCare Warm Vanilla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57337-074-01	XtraCare Warm Vanilla	237 g in 1 BOTTLE	GEL	237		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
CARBOMER COPOLYMER TYPE A	INACTIVE INGREDIENT	71DD5V995L	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57337-074	XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [REJOICE INTERNATIONAL]	3	Current NDC, Legacy NDC, 1 package rows	20250214_46e7b4fa-3722-4487-9325-f8552ea92acf.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 47 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Smart Care Hand Sanitizer Champagne Toast	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	479beac0-16bc-a88c-e063-6394a90a42f5	2026-01-04	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Silicone Case 3pk	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	478b0ba2-d8ce-8101-e063-6294a90a6464	2026-01-03	Warnings	Exact identifier application number: M003
CASA COLADA SAPRY HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	47679265-2ec3-4c62-e063-6294a90a60b6	2026-01-02	Warnings	Exact identifier application number: M003
Fiji Punch Hand Sanitizer	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4767ed4b-ebec-ca75-e063-6294a90a82d3	2026-01-02	Warnings	Exact identifier application number: M003
VILLA VANILLA HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	47682ec1-5479-2ea5-e063-6394a90aa192	2026-01-02	Warnings	Exact identifier application number: M003
Wipex Sanitizing Wipes	BENZALKONIUM CHLORIDE	Unico	476d7085-82d8-5e84-e063-6394a90a6448	2026-01-02	Warnings	Exact identifier application number: M003
Alcohol Pad	ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co.,Ltd.	74dc43d1-2aba-4f8a-876a-ce712ad37eeb	2026-01-01	Warnings	Exact identifier application number: M003
Antiseptic wipe	BENZALKONIUM CHLORIDE	Yiwu Ori-Power Medtech Co.,Ltd.	fc4fc127-3130-4891-b390-6dc823cb30d4	2026-01-01	Warnings	Exact identifier application number: M003
Iodine Prep Pad Antiseptic	POVIDONE-IODINE	Yiwu Ori-Power Medtech Co.,Ltd.	0fdded64-4e89-d28c-e063-6394a90a7b8f	2026-01-01	Warnings	Exact identifier application number: M003
OP First Aid Series Alcohol Prep Pad	ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co., Ltd.	b3da7cff-4555-358e-e053-2995a90ae0ff	2026-01-01	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	Astera International LLC	a5189240-19ce-7715-e053-2995a90ad043	2025-12-31	Warnings	Exact identifier application number: M003
Water Jel Hydrogen Peroxide	HYDROGEN PEROXIDE	Water-Jel Technologies	f508c3cb-e162-4d11-9513-ff44918f82c0	2025-12-31	Warnings	Exact identifier application number: M003
HEB 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	HEB Grocery Company	e8dd7f84-3690-4ab3-a21f-43bf66984f4b	2025-12-30	Warnings	Exact identifier application number: M003
Hand Sanitizer	ALCOHOL	HAIAN KANGRUI TEXTILE CO., LTD.	4711fb91-8afd-e5db-e063-6394a90a4b9e	2025-12-29	Warnings	Exact identifier application number: M003
Antiseptic	BENZETHONIUM CHLORIDE	MPM Medical, LLC	3f660269-f83d-4f71-9a70-e2ddb2c57ec6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizing Spry	HAND SANITIZER SPRAY	SnugZ/USA, LLC	9391bc26-57e6-daec-e053-2995a90a1eb6	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Beaded Hand Sanitizer Gel	BEADED HAND SANITIZER GEL	SnugZ/USA, LLC	6deb1142-dfba-a72b-e053-2991aa0aba43	2025-12-29	Warnings	Exact identifier application number: M003
SnugZ Hand Sanitizer Gel	HAND SANITIZER GEL	SnugZ/USA, LLC	69bc7a80-0898-4c08-e053-2a91aa0a87a9	2025-12-29	Warnings	Exact identifier application number: M003
Englewood Mesh Amenity	BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	a737fe63-6285-41ee-9516-9c3030a0ab48	2025-12-29	Warnings	Exact identifier application number: M003
Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	4710c90b-ce88-b0b8-e063-6294a90a3860	2025-12-28	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	46e7b4fa-3722-4487-9325-f8552ea92acf	3
581660	ethanol 0.62 ML/ML Topical Gel	SCD	46e7b4fa-3722-4487-9325-f8552ea92acf	3
581660	ethanol 62 % Topical Gel	SY	46e7b4fa-3722-4487-9325-f8552ea92acf	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57337-074-01	57337007401	237 g in 1 BOTTLE (57337-074-01)	237 g	2015-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XtraCare Warm Vanilla	Rejoice International \| China Ningbo Shangge Cosmetic Technology Corp	2025-02-12	HUMAN OTC DRUG LABEL	3