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

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 Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53118-002-012020-07-08C16284748780-19d75b9d1-2130-f424-e053-dadaa90a57ceDrug Facts
53118-002-022020-07-08C16284748780-19d75b9d1-2130-f424-e053-dadaa90a57ceDrug Facts
53118-002-012020-01-31C16284748780-19d75b9d1-2130-f424-e053-dadaa90a57ceDrug Facts
53118-002-022020-01-31C16284748780-19d75b9d1-2130-f424-e053-dadaa90a57ceDrug 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

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