FDA.reportPublic FDA data

Sanitex Antibacterial Hand Wipes

Product NDC
53118-002
11-digit product format
531180002
Labeler code
53118
Product ID
53118-002_453a544a-99f3-bcdc-e063-6394a90ab429
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Precare Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-17
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct53118-002IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53118-00253118-002-02IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53118-00253118-002-01IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
Sanitex Antibacterial Hand Wipes
Brand name suffix
Fresh Scent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48907146-ca66-46e1-928b-a8f968a6bff8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
53118-002-012020-07-08Drug Facts
53118-002-022020-07-08Drug Facts
53118-002-012020-01-31Drug Facts
53118-002-022020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53118-002-01Sanitex Antibacterial Hand WipesFresh Scent3 g in 1 PACKAGESWAB38
53118-002-01Sanitex Antibacterial Hand WipesFresh Scent40 in 1 CANISTERSWAB408
53118-002-02Sanitex Antibacterial Hand WipesFresh Scent3 g in 1 POUCHSWAB38
53118-002-02Sanitex Antibacterial Hand WipesFresh Scent20 in 1 BAGSWAB208
53118-002-03Sanitex Antibacterial Hand WipesFresh Scent1 in 1 PACKAGESWAB18
53118-002-03Sanitex Antibacterial Hand WipesFresh Scent3 g in 1 PACKAGESWAB38

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RSANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PREMIER CARE INDUSTRIES, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53118-002SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT (BENZALKONIUM CHLORIDE) SWAB [PRECARE CORP]7Current NDC, Legacy NDC, 6 package rows20241211_48907146-ca66-46e1-928b-a8f968a6bff8.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 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 0.13 % Topical ClothSY48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 0.13 % Topical SwabSY48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY48907146-ca66-46e1-928b-a8f968a6bff88
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY48907146-ca66-46e1-928b-a8f968a6bff88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53118-002-015311800020140 PACKAGE in 1 CANISTER (53118-002-01) / 3 g in 1 PACKAGE40 package2015-06-170000-00-00NoNoCurrent
53118-002-025311800020220 POUCH in 1 BAG (53118-002-02) / 3 g in 1 POUCH20 pouch2015-06-170000-00-00NoNoCurrent
53118-002-03531180002031 PACKAGE in 1 PACKAGE (53118-002-03) / 3 g in 1 PACKAGE1 package2020-07-100000-00-00NoNoCurrent