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 50 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol Wipes	ALCOHOL WIPES	ProStat First Aid LLC	0e0ef369-a0e7-5320-e063-6394a90a353f	2025-12-15	Warnings	Exact identifier application number: M003
Antiseptic Wipes	ANTISEPTIC WIPES	ProStat First Aid LLC	0e11238b-e5f2-075f-e063-6394a90aa825	2025-12-15	Warnings	Exact identifier application number: M003
3% HYDROGEN PEROXIDE	HYDROGEN PEROXIDE	Universal Distribution Center LLC	53573a9c-bddc-49ea-931e-4779a20eb14f	2025-12-15	Warnings	Exact identifier application number: M003
Hand sanitizer	HAND SANITIZER SPRAY	Guangzhou Baihua Co., Ltd	3aab4b75-7a52-46b1-e063-6294a90a7253	2025-12-14	Warnings	Exact identifier application number: M003
Hand sanitizer	HAND SANITIZER SPRAY	Guangzhou Baihua Co., Ltd	3aab2ced-cc6f-2c20-e063-6294a90a36d9	2025-12-14	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	4 Visions LLC	45c3c6da-5217-5c2b-e063-6294a90a56d3	2025-12-12	Warnings	Exact identifier application number: M003
ORBIT INNOVATIONS HAND SANITIZER	ALCOHOL ANTISEPTIC GEL	Kingkey MBC Life Technology Group Co.,Ltd	1abf5aca-346f-0d18-e063-6294a90a9339	2025-12-11	Warnings	Exact identifier application number: M003
Deeyeo	DISINFECTING WET WIPES	Henan Yeesain Health Technology Co., Ltd.	45b33db6-13b4-5e28-e063-6294a90a6ea1	2025-12-11	Warnings	Exact identifier application number: M003
DEYO	DISINFECTING WET WIPES	Henan Yeesain Health Technology Co., Ltd.	b147ed5b-ab6e-ca00-e053-2a95a90ae01a	2025-12-10	Warnings	Exact identifier application number: M003
BIOCENCE	EUCALYPTOL THYMOL	Bio-Germ Protection LLC	1ea56ac9-4fc2-41c0-adda-5a2c55bef696	2025-12-10	Warnings	Exact identifier application number: M003
BIOCENCE	EUCALYPTOL THYMOL	Bio-Germ Protection LLC	847b9edc-74e6-43fd-83cd-43e6712780c6	2025-12-10	Warnings	Exact identifier application number: M003
The Pharma-C Company 70 Isopropyl Alcohol Pads	ISOPROPYL ALCOHOL	Kleen Test Products Corporation	c5df867b-1b8d-4e38-8c32-7d528b982590	2025-12-09	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	bf399508-bd29-0d90-e053-2995a90a067f	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceb351a-06fb-8222-e053-2a95a90aadbf	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dcead234-bb98-1ee8-e053-2a95a90a3186	2025-12-06	Warnings	Exact identifier application number: M003
75% Alcohol Disinfectant	ALCOHOL	Zhejiang Meimi Technology Co., Ltd.	acfdfa78-69e7-27dc-e053-2a95a90a8548	2025-12-06	Warnings	Exact identifier application number: M003
75% Alcohol Disinfectant	ALCOHOL	Zhejiang Meimi Technology Co., Ltd.	ad0cdcf1-7d8b-dcc9-e053-2995a90a4b4b	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dceb9358-663c-3c70-e053-2995a90a3524	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dced08e7-a0bc-1328-e053-2995a90afb26	2025-12-06	Warnings	Exact identifier application number: M003
Hand Sanitizer	HAND SANITIZER	Zhejiang Meimi Technology Co., Ltd.	dcec13da-586c-6e7e-e053-2a95a90a6cd1	2025-12-06	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