FDA.reportPublic FDA data

XtraCare Hand Sanitizer

Product NDC
58503-044
Requested package NDC
58503-044-01
11-digit product format
585030044
Labeler code
58503
Product ID
58503-044_926fa735-4a2f-981e-e053-2995a90a7da9
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
2014-01-24
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
146 g/236g
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 packagepackage58503-04458503-044-01IInactivated by FDA2026-10-15

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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-044-012024-01-30C16284748780-11030e365-1626-111a-e063-dadaa90a10e2XtraCare Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-044-01XtraCare Hand SanitizerMoisurize with Vitamin E and Aloe236 g in 1 BOTTLEGEL2362

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALCOHOLACTIVE MOIETY3K9958V90MXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0XTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-044XTRACARE HAND SANITIZER MOISURIZE WITH VITAMIN E AND ALOE (ETHYL ALCOHOL) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2Legacy NDC, 1 package rows20190914_00e50929-0bc0-4cb0-ba92-2a1f7796ae5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN00e50929-0bc0-4cb0-ba92-2a1f7796ae5b2
581660ethanol 0.62 ML/ML Topical GelSCD00e50929-0bc0-4cb0-ba92-2a1f7796ae5b2
581660ethanol 62 % Topical GelSY00e50929-0bc0-4cb0-ba92-2a1f7796ae5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-044-0158503004401236 g in 1 BOTTLE (58503-044-01) 236 g2014-01-240000-00-00NoNoCurrent