FDA.reportPublic FDA data

WET ONES

Product NDC
63354-926
11-digit product format
633540926
Labeler code
63354
Product ID
63354-926_23e82932-025a-b4a0-e063-6394a90aa887
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
2023-10-01
Marketing end
2026-10-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WET ONES

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
069b3f9d-0306-059b-e063-6294a90af42cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-926-24WET ONES24 in 1 BOXSWAB244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-926WET ONES (BENZALKONIUM CHLORIDE) SWAB [EDGEWELL PERSONAL CARE BRANDS LLC]4Current NDC, 1 package rows20241009_069b3f9d-0306-059b-e063-6294a90af42c.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 LLC069b3f9d-0306-059b-e063-6294a90af42c2024-10-07WarningsExact identifier
ndc (product): 63354-926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 0.13 % Topical ClothSY069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 0.13 % Topical SwabSY069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY069b3f9d-0306-059b-e063-6294a90af42c4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY069b3f9d-0306-059b-e063-6294a90af42c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-926-246335409262424 SWAB in 1 BOX (63354-926-24) 24 swab2023-10-012026-10-01NoNoHistorical