FDA.reportPublic FDA data

WET ONES

Product NDC
63354-926
Requested package NDC
63354-926-24
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 63354-926-24
ndc (product): 63354-926
ndc11 (package): 63354092624

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

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