XtraCare Warm Vanilla

Product NDC: 57337-074
Requested package NDC: 57337-074-01
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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57337-074	57337-074-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57337-074	57337-074-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57337-074	57337-074-01	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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 79 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Germ Attack 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Natural Essentials, Inc.	3375d44e-5af6-8c7f-e063-6394a90abb4b	2025-04-25	Warnings	Exact identifier application number: M003
Germ Attack 91% Isopropyl Alcohol	ISOPROPYL ALCOHOL	Natural Essentials, Inc.	3375e0d7-07fa-6489-e063-6294a90a91ec	2025-04-25	Warnings	Exact identifier application number: M003
Clear Defense	HAND SANITIZING WIPES	Melaleuca, Inc.	30dec472-8112-37d6-e063-6294a90a1f25	2025-04-24	Warnings	Exact identifier application number: M003
Quality Choice Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	Chain Drug Marketing Association, Inc.	3347184c-ae72-bec2-e063-6294a90a2d05	2025-04-23	Warnings	Exact identifier application number: M003
Dukal Sterile Alcohol Prep Pad	ISOPROPYL ALCOHOL	Dukal LLC	00b2c444-8601-4d8f-b6bb-91b864fd9041	2025-04-23	Warnings	Exact identifier application number: M003
PREVENT HAND SANITIZER	ALCOHOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	ee2c3dd2-a82f-4bbf-a288-f0365b9893db	2025-04-23	Warnings	Exact identifier application number: M003
SANIFOAM HAND SANITIZER	ALCOHOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	e1cfa8ff-92e0-4931-98c9-287c8dcd5a99	2025-04-23	Warnings	Exact identifier application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	18720bd0-6ea8-2d1b-e063-6394a90abe2d	2025-04-23	Warnings	Exact identifier application number: M003
E-2 HAND ITEM 1095	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	18728ebb-c416-5efe-e063-6294a90abd91	2025-04-23	Warnings	Exact identifier application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1871b1db-f881-e7fd-e063-6294a90ada98	2025-04-23	Warnings	Exact identifier application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1870b08e-e5c3-7888-e063-6394a90a1c82	2025-04-23	Warnings	Exact identifier application number: M003
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063	CHLOROXYLENOL	AMERICAN CHEMICAL AND SANITARY SUPPLY INC	1871e729-6b76-084e-e063-6394a90a795d	2025-04-23	Warnings	Exact identifier application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED	LIDOCAINE, MENTHOL	Compass Health Brands Corp.	2c38a4be-fcbe-9d1d-e063-6294a90a9373	2025-04-22	Warnings	Exact identifier application number: M003
Sierra Soft Antibacterial Wash	CHLOROXYLENOL	CWGC LA Inc.	49034ae5-be47-4472-a4e5-b5bf633355ed	2025-04-21	Warnings	Exact identifier application number: M003
Aplicare	HYDROGEN PEROXIDE	Aplicare Products LLC	0b3e5df6-03c8-3880-e063-6394a90a1cdc	2025-04-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Total Resources International	b971cc41-fe23-4be3-9564-e46d55df1d68	2025-04-18	Warnings	Exact identifier application number: M003
Sierra Soft Alcohol Hand Sanitizer	ETHYL ALCOHOL	CWGC LA Inc.	012463da-94cf-4975-9fa2-6c323855bf57	2025-04-17	Warnings	Exact identifier application number: M003
Biopure	HAND SANITIZER SPRAY	Quest USA Corp	323c61fd-adee-393c-e063-6394a90a5eb3	2025-04-15	Warnings	Exact identifier application number: M003
Biopure	HAND SANITIZER SPRAY	Quest USA Corp	324b140d-9d43-1c2f-e063-6294a90ae303	2025-04-15	Warnings	Exact identifier application number: M003
Isopropyl alcohol 70 percent	ISOPROPYL ALCOHOL	TARGET Corporation	126ec829-c54c-4927-bbd5-a8156d2f6eea	2025-04-14	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