FDA.reportPublic FDA data

BZK Antiseptic Towelette Sterile

Product NDC
34645-0018
Requested package NDC
34645-0018-1
11-digit product format
346450018
Labeler code
34645
Product ID
34645-0018_085e7fe4-e6ae-9dd9-e063-6294a90a9d87
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
BZK Antiseptic Towelette Sterile
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
f787ff2f-0cdf-46ee-b401-603e34a76770Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0018-1BZK Antiseptic Towelette Sterile1 in 1 POUCHCLOTH13
34645-0018-1BZK Antiseptic Towelette Sterile1.6 g in 1 PATCHCLOTH1.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0018BZK ANTISEPTIC TOWELETTE STERILE (BENZALKONIUM CHLORIDE) CLOTH [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231024_f787ff2f-0cdf-46ee-b401-603e34a76770.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
BZK Antiseptic Towelette SterileBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdf787ff2f-0cdf-46ee-b401-603e34a767702023-10-23WarningsExact identifier
ndc (package): 34645-0018-1
ndc (product): 34645-0018
ndc11 (package): 34645001801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 0.13 % Topical ClothSYf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 0.13 % Topical SwabSYf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYf787ff2f-0cdf-46ee-b401-603e34a767703
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYf787ff2f-0cdf-46ee-b401-603e34a767703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0018-1346450018011 PATCH in 1 POUCH (34645-0018-1) / 1.6 g in 1 PATCH1 patch2021-08-010000-00-00NoNoCurrent