FDA.reportPublic FDA data

Antiseptic Towelette TOALLITAS ANTISEPTICAS

Product NDC
84219-004
11-digit product format
842190004
Labeler code
84219
Product ID
84219-004_1507887f-14cc-8244-e063-6394a90aeaeb
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
M-star (Hubei) Health&Care Products Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Antiseptic Towelette TOALLITAS ANTISEPTICAS
Listing expiration
2027-12-31

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
b267e186-cf7a-458f-9c28-a48a8554af40Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84219-004-00Antiseptic Towelette TOALLITAS ANTISEPTICAS1 in 1 POUCHCLOTH11
84219-004-00Antiseptic Towelette TOALLITAS ANTISEPTICAS1 g in 1 PATCHCLOTH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84219-004ANTISEPTIC TOWELETTE TOALLITAS ANTISEPTICAS (BENZALKONIUM CHLORIDE) CLOTH [M-STAR (HUBEI) HEALTH&CARE PRODUCTS CO., LTD.]1Current NDC, 2 package rows20240515_b267e186-cf7a-458f-9c28-a48a8554af40.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 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Honeydew TartETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC462b39e9-cf8e-3268-e063-6394a90a69c02025-12-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pear BlossomETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.462a1437-154c-0324-e063-6294a90a12662025-12-17WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLFamily Dollar Stores, Inc.15af30ec-f77d-2f5c-e063-6394a90a05802025-12-17WarningsExact identifier
application number: M003
Signature Select Isopropyl Alcohol Wipes (40 count)ISOPROPYL ALCOHOLBetter Living Brands LLCc9efcad4-f85c-4b10-9984-55549a4ff0262025-12-17WarningsExact identifier
application number: M003
finipil 4 men onlyBENZETHONIUM CHLORIDEEquibal, Inc.aba2e3e6-6047-416d-8ca3-44f1033671e32025-12-17WarningsExact identifier
application number: M003
finipil pro/elecBENZETHONIUM CHLORIDEEquibal, Inc.f68aa5db-7a4e-410f-8159-3356d9407d312025-12-17WarningsExact identifier
application number: M003
Made for MenBENZETHONIUM CHLORIDEEquibal, Inc.d12f748d-7dc5-4cd7-9718-ebb47171d58b2025-12-17WarningsExact identifier
application number: M003
QuickMendBENZETHONIUM CHLORIDEEquibal, Inc.9b0c85a4-9727-4940-a934-0b81a7c938cf2025-12-17WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 0.13 % Topical ClothSYb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 0.13 % Topical SwabSYb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYb267e186-cf7a-458f-9c28-a48a8554af401
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYb267e186-cf7a-458f-9c28-a48a8554af401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84219-004-00842190004001 PATCH in 1 POUCH (84219-004-00) / 1 g in 1 PATCH1 patch2024-05-15NoNoCurrent