FDA.reportPublic FDA data

Barbie BZK ANTISEPTIC WIPE

Product NDC
70108-107
Requested package NDC
70108-107-01
11-digit product format
701080107
Labeler code
70108
Product ID
70108-107_065fe929-178c-4acd-84b5-5bf4f1cb7123
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Ashtel Studios, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-30
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Barbie BZK ANTISEPTIC WIPE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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
d675eb91-80a8-4874-a2b0-c2bf69264911Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-107-01Barbie BZK ANTISEPTIC WIPE1 in 1 POUCHCLOTH11
70108-107-01Barbie BZK ANTISEPTIC WIPE0.0011 mL in 1 PACKAGECLOTH0.00111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-107BARBIE BZK ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE) CLOTH [ASHTEL STUDIOS, INC.]1Current NDC, 2 package rows20241130_d675eb91-80a8-4874-a2b0-c2bf69264911.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 49 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLDynarex Corporation39b20f1b-8d2f-4fa0-8cb9-10cad408e0642025-12-16WarningsExact identifier
application number: M003
finipil Lait 50BENZETHONIUM CHLORIDEEquibal, Inc.bc630fbc-e428-4d46-8330-fb6f699943fd2025-12-16WarningsExact identifier
application number: M003
PS-2205 BZK Antiseptic TowelettesPS-2205 BZK ANTISEPTIC TOWELETTESProStat First Aid LLC00772636-8265-a937-e063-6294a90a438a2025-12-15WarningsExact identifier
application number: M003
PS-2362 Hand Sanitizer 0.9g packetPS-2362 HAND SANITIZER 0.9G PACKETProStat First Aid LLC01c87dff-57e0-017a-e063-6394a90a16002025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e120fed-3225-520b-e063-6394a90a9f9e2025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProstat First Aid LLC0e241343-db64-3f1c-e063-6394a90ab5382025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESFront Line Safety0e0ca589-834b-495b-e063-6394a90afbd02025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0dd88e-62eb-02c8-e063-6394a90a63d82025-12-15WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZERProStat First Aid LLC0e21f466-d6ed-79c4-e063-6394a90ae9882025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0dfd48bb-3353-6062-e063-6294a90af6282025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESFront Line Safety0e1f3653-d75e-9c9e-e063-6294a90ab6392025-12-15WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESProStat First Aid LLC0e0ef369-a0e7-5320-e063-6394a90a353f2025-12-15WarningsExact identifier
application number: M003
Antiseptic WipesANTISEPTIC WIPESProStat First Aid LLC0e11238b-e5f2-075f-e063-6394a90aa8252025-12-15WarningsExact identifier
application number: M003
3% HYDROGEN PEROXIDEHYDROGEN PEROXIDEUniversal Distribution Center LLC53573a9c-bddc-49ea-931e-4779a20eb14f2025-12-15WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab4b75-7a52-46b1-e063-6294a90a72532025-12-14WarningsExact identifier
application number: M003
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd3aab2ced-cc6f-2c20-e063-6294a90a36d92025-12-14WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC45c3c6da-5217-5c2b-e063-6294a90a56d32025-12-12WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZERALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd1abf5aca-346f-0d18-e063-6294a90a93392025-12-11WarningsExact identifier
application number: M003
DeeyeoDISINFECTING WET WIPESHenan Yeesain Health Technology Co., Ltd.45b33db6-13b4-5e28-e063-6294a90a6ea12025-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 0.13 % Topical ClothSYd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 0.13 % Topical SwabSYd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYd675eb91-80a8-4874-a2b0-c2bf692649111
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYd675eb91-80a8-4874-a2b0-c2bf692649111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70108-107-01701080107011 PACKAGE in 1 POUCH (70108-107-01) / .0011 mL in 1 PACKAGE1 package2024-11-30NoNoCurrent