FDA.reportPublic FDA data

XtraCare Warm Vanilla

Product NDC
58503-074
Requested package NDC
58503-074-01
11-digit product format
585030074
Labeler code
58503
Product ID
58503-074_9270c1c6-9358-7fdc-e053-2995a90a1547
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-17
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58503-07458503-074-01IInactivated by FDA2026-10-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-074-012024-01-30C16284748780-11030e365-0fda-111a-e063-dadaa90a10e2XtraCare Warm Vanilla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-074-01XtraCare Warm Vanilla237 g in 1 BOTTLEGEL2372

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALCOHOLACTIVE MOIETY3K9958V90MXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995LXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-074XTRACARE WARM VANILLA (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2Legacy NDC, 1 package rows20190914_1aefcd50-3eee-406e-bba8-db7f0a7ff71e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN1aefcd50-3eee-406e-bba8-db7f0a7ff71e2
581660ethanol 0.62 ML/ML Topical GelSCD1aefcd50-3eee-406e-bba8-db7f0a7ff71e2
581660ethanol 62 % Topical GelSY1aefcd50-3eee-406e-bba8-db7f0a7ff71e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-074-0158503007401237 g in 1 BOTTLE (58503-074-01) 237 g2015-02-170000-00-00NoNoCurrent