FDA.reportPublic FDA data

XtraCare Foam Antibacterial Hand Wash

Product NDC
58503-050
Requested package NDC
58503-050-01
11-digit product format
585030050
Labeler code
58503
Product ID
58503-050_926fe00e-f2ca-63f8-e053-2995a90a50ad
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-01-29
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 g/444g
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 packagepackage58503-05058503-050-01IInactivated by FDA2026-10-05

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
58503-050-012024-01-30C16284748780-11030e365-4ae3-111a-e063-dadaa90a10e2XtraCare Foam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-050-01XtraCare Foam Antibacterial Hand WashRefill Pink Cherry Blossom444 g in 1 BOTTLESOAP4442

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CETRIMONIUM CHLORIDEINACTIVE INGREDIENTUC9PE95IBPXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
LAURAMINE OXIDEINACTIVE INGREDIENT4F6FC4MI8WXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-050XTRACARE FOAM ANTIBACTERIAL HAND WASH REFILL PINK CHERRY BLOSSOM (BENZALKONIUM CHLORIDE) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]2Legacy NDC, 1 package rows20190914_080dafce-91fa-43a5-8b3c-48600c987cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN080dafce-91fa-43a5-8b3c-48600c987cb32
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD080dafce-91fa-43a5-8b3c-48600c987cb32
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY080dafce-91fa-43a5-8b3c-48600c987cb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-050-0158503005001444 g in 1 BOTTLE (58503-050-01) 444 g2014-01-290000-00-00NoNoCurrent