FDA.reportPublic FDA data

WET ONES

Product NDC
63354-774
Requested package NDC
63354-774-40
11-digit product format
633540774
Labeler code
63354
Product ID
63354-774_3f048518-e583-ea73-e063-6394a90a4600
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SWAB
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-17
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WET ONES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/1

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
225275f3-58aa-36d6-e063-6394a90adc13Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-774-14WET ONES140 in 1 PACKETSWAB1404
63354-774-20WET ONES20 in 1 POUCHSWAB204
63354-774-24WET ONES24 in 1 PACKETSWAB244
63354-774-40WET ONES40 in 1 CANISTERSWAB404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-774WET ONES (BENZALKONIUM CHLORIDE) SWAB [EDGEWELL PERSONAL CARE BRANDS LLC]3Current NDC, 4 package rows20241027_225275f3-58aa-36d6-e063-6394a90adc13.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WET ONESBENZALKONIUM CHLORIDEEdgewell Personal Care Brands LLC225275f3-58aa-36d6-e063-6394a90adc132025-09-17WarningsExact identifier
ndc (package): 63354-774-40
ndc (product): 63354-774
ndc11 (package): 63354077440

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 0.13 % Topical ClothSY225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 0.13 % Topical SwabSY225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY225275f3-58aa-36d6-e063-6394a90adc134
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY225275f3-58aa-36d6-e063-6394a90adc134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63354-774-406335407744040 SWAB in 1 CANISTER (63354-774-40) 40 swab2024-09-17NoNoCurrent