FDA.reportPublic FDA data

Cleansing Towelette

Product NDC
34645-0019
11-digit product format
346450019
Labeler code
34645
Product ID
34645-0019_085eab46-3c27-cf27-e063-6294a90a30fd
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cleansing Towelette
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g

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
13c23da8-51d7-480c-b8ae-5bf91043d0a3Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0019-1Cleansing Towelette1.6 g in 1 PATCHCLOTH1.63
34645-0019-1Cleansing Towelette1 in 1 POUCHCLOTH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0019CLEANSING TOWELETTE (BENZALKONIUM CHLORIDE) CLOTH [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231024_13c23da8-51d7-480c-b8ae-5bf91043d0a3.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
Cleansing ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd13c23da8-51d7-480c-b8ae-5bf91043d0a32023-10-23WarningsExact identifier
ndc (product): 34645-0019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 0.13 % Topical ClothSY13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 0.13 % Topical SwabSY13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY13c23da8-51d7-480c-b8ae-5bf91043d0a33
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY13c23da8-51d7-480c-b8ae-5bf91043d0a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0019-1346450019011 PATCH in 1 POUCH (34645-0019-1) / 1.6 g in 1 PATCH1 patch2021-08-010000-00-00NoNoCurrent