FDA.reportPublic FDA data

XtraCare Wet Wipes

Product NDC
58503-062
Requested package NDC
58503-062-01
11-digit product format
585030062
Labeler code
58503
Product ID
58503-062_92702db8-1264-414f-e053-2995a90ac1f5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzethonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-03-13
Marketing end
0000-00-00
Substance
BENZETHONIUM CHLORIDE
Active strength
3 mg/100mg
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 packagepackage58503-06258503-062-01IInactivated 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
58503-062-012024-01-30C16284748780-11030e365-6e78-111a-e063-dadaa90a10e2XtraCare Wet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-062-01XtraCare Wet Wipes100 mg in 1 APPLICATORSWAB1002
58503-062-01XtraCare Wet Wipes18 in 1 PACKAGESWAB182

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-062XTRACARE WET WIPES (BENZETHONIUM CHLORIDE) SWAB [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP]2Legacy NDC, 2 package rows20190914_40c3da74-ef05-4ddd-802f-b9a98f814da7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043348benzethonium Cl 0.3 % Medicated PadPSN40c3da74-ef05-4ddd-802f-b9a98f814da72
1043348benzethonium chloride 3 MG/ML Medicated PadSCD40c3da74-ef05-4ddd-802f-b9a98f814da72
1043348benzethonium chloride 0.3 % Medicated WipeSY40c3da74-ef05-4ddd-802f-b9a98f814da72
1043348benzethonium chloride 0.3 % Topical ClothSY40c3da74-ef05-4ddd-802f-b9a98f814da72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-062-015850300620118 APPLICATOR in 1 PACKAGE (58503-062-01) > 100 mg in 1 APPLICATOR18 applicator2014-03-130000-00-00NoNoCurrent