FDA.reportPublic FDA data

Wet Wipes

Product NDC
57337-067
Requested package NDC
57337-067-01
11-digit product format
573370067
Labeler code
57337
Product ID
57337-067_2decea86-6c83-78bc-e063-6394a90a5383
Type
HUMAN OTC DRUG
Nonproprietary name
benzethonium chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Rejoice International
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-08
Substance
BENZETHONIUM CHLORIDE
Active strength
.3 g/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57337-06757337-067-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-06757337-067-01UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-06757337-067-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Wet Wipes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZETHONIUM CHLORIDE.3 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PH41D05744Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043348Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ffcf0c2-409f-4dea-b296-b5ccb61399dfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-067-012025-02-12C16284748780-12cef2736-8e49-d83d-e063-dadaa90ab31fWet Wipes
57337-067-012025-01-30C16284748780-12cef2736-8e49-d83d-e063-dadaa90ab31fWet Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-067-01Wet Wipes32 in 1 PACKAGECLOTH323

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744WET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RWET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-067WET WIPES (BENZETHONIUM CHLORIDE) CLOTH [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20250214_0ffcf0c2-409f-4dea-b296-b5ccb61399df.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 63 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVR Alcohol Prep PadsISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffba233-6106-f633-e063-6394a90a96fe2025-09-29WarningsExact identifier
application number: M003
ProHeal Alcohol Prep PadISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.3ffc0619-eb13-77af-e063-6394a90a2fd92025-09-29WarningsExact identifier
application number: M003
ProHeal BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd.3ffc3f34-086d-1d18-e063-6294a90a71bb2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Alcohol WipeISOPROPYL ALCOHOLCintas Corporation6a71449e-9a97-4923-8ec1-b1deb45b57462025-09-29WarningsExact identifier
application number: M003
Northside Hospital Mothers Kit, Grey BackpackALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc0868060e-d593-4cb2-b3d2-6c59d1ae5efc2025-09-29WarningsExact identifier
application number: M003
First Aid Direct Antiseptic WipeBENZALKONIUM CHLORIDECintas Corporationa23f3685-7213-4cc0-97b2-588fb12247922025-09-29WarningsExact identifier
application number: M003
Xpect Alcohol WipesALCOHOL WIPESCintas Corporation51185b9a-ed6b-4a49-b524-b3ff0d5c62902025-09-29WarningsExact identifier
application number: M003
Super-Stop BloodClotterBLOOD CLOTTERCintas Corpd910ee9b-187d-49a9-ab96-281730db25752025-09-26WarningsExact identifier
application number: M003
Hand Sanitizer plus HolderBENZALKONIUM CHLORIDEAocai Biotechnology Huizhou Co Ltd3fa738ce-0a04-fa11-e063-6294a90aba882025-09-25WarningsExact identifier
application number: M003
Fresh Feels Hand SanitizerFRESH FEELS HAND SANITIZERZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3e36e2c4-fe4d-d517-e063-6394a90ac4be2025-09-25WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEJell Pharmaceuticals Pvt Ltd.ddc59e50-083a-6cd9-e053-2995a90ad4012025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(CHERRY)HAND SANITIZER(CHERRY)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6cc842-8b54-9a27-e063-6294a90a1dd52025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(PEACH)HAND SANITIZER(PEACH)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6bf6be-5328-8151-e063-6294a90a82112025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(COCONUT)HAND SANITIZER(COCONUT)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6ca090-98d9-4650-e063-6294a90a35c02025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer(MANGO)HAND SANITIZER(MANGO)ZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD3d6c79b9-d4b1-bbaf-e063-6394a90a11002025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Matcha MoodALCOHOLScent Theory Products LLC3f8fc09d-863d-0c13-e063-6394a90a49682025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Ocean MistALCOHOLScent Theory Products LLC3f8fd236-e413-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
application number: M003
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043348benzethonium Cl 0.3 % Medicated PadPSN0ffcf0c2-409f-4dea-b296-b5ccb61399df3
1043348benzethonium chloride 3 MG/ML Medicated PadSCD0ffcf0c2-409f-4dea-b296-b5ccb61399df3
1043348benzethonium chloride 0.3 % Medicated WipeSY0ffcf0c2-409f-4dea-b296-b5ccb61399df3
1043348benzethonium chloride 0.3 % Topical ClothSY0ffcf0c2-409f-4dea-b296-b5ccb61399df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-067-015733700670132 CLOTH in 1 PACKAGE (57337-067-01) 32 cloth2014-12-080000-00-00NoNoCurrent