FDA.reportPublic FDA data

BZK Antiseptic Towelette

Product NDC
83446-201
11-digit product format
834460201
Labeler code
83446
Product ID
83446-201_473afd4f-5927-7b07-e063-6294a90a4358
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride cloth
Dosage form
CLOTH
Route
TOPICAL
Labeler
JINHUA JINGDI MEDICAL SUPPLIES CO., LTD
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-28
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83446-201-01BZK Antiseptic Towelette1.5 g in 1 POUCHCLOTH1.52
83446-201-01BZK Antiseptic Towelette10000 in 1 CARTONCLOTH100002
83446-201-02BZK Antiseptic Towelette10000 in 1 CARTONCLOTH100001
83446-201-02BZK Antiseptic Towelette1.5 g in 1 POUCHCLOTH1.51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 0.13 % Topical ClothSY470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 0.13 % Topical SwabSY470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY470fca9f-a819-2290-e063-6294a90abad82
1038558benzalkonium chloride 0.13 % Medicated PadPSN4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 0.13 % Topical ClothSY4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 0.13 % Topical SwabSY4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY4bdf2ad9-ba7d-6252-e063-6294a90a59761
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY4bdf2ad9-ba7d-6252-e063-6294a90a59761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83446-201-018344602010110000 POUCH in 1 CARTON (83446-201-01) / 1.5 g in 1 POUCH10000 pouch2025-12-28NoNoCurrent
83446-201-028344602010210000 POUCH in 1 CARTON (83446-201-02) / 1.5 g in 1 POUCH10000 pouch2026-01-01NoNoCurrent