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 75 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer - Sweet CitrusALCOHOLShenzhen Lantern Scicence Co.,Ltd.38863865-9361-fd1a-e063-6394a90a84f42025-06-26WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Squishmallows PattyALCOHOLShenzhen Lantern Scicence Co.,Ltd.38613f78-8480-637d-e063-6394a90a4ef32025-06-25WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.38626ced-5644-9f82-e063-6294a90ac7a12025-06-25WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Pistachio BruleALCOHOLShenzhen Lantern Scicence Co.,Ltd.38715507-d881-d8b3-e063-6394a90ad3482025-06-25WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer - Juicy BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.3871ec77-de30-0c89-e063-6394a90a9e7a2025-06-25WarningsExact identifier
application number: M003
Meijer Hydrating Power Mist Hand Sanitizer- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.384c26c8-7f2d-8c3a-e063-6394a90aa9082025-06-24WarningsExact identifier
application number: M003
Good Neighbor Pharmacy Alcohol Antiseptic Skin CleanserISOPROPYL ALCOHOLAmerisouce Bergenfc28cf11-afb9-4295-bee3-735ab10f6bbc2025-06-24WarningsExact identifier
application number: M003
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.38381a41-db33-45c6-e063-6394a90a23172025-06-23WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGERite Aid Corporation1069226f-dfd0-4028-a033-30fa4b1e835e2025-06-21WarningsExact identifier
application number: M003
Cart Wipes Clean Sanitizing WipesBENZALKONIUM CHLORIDECarts and Parts INC.6a8433e8-7b96-44ce-b8e2-c60575898dab2025-06-18WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
application number: M003
Sweet Orange Bergamot and AloeETHYL ALCOHOLALO New York LLC31cecf1e-1d6b-0033-e063-6294a90a7b8e2025-06-18WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEAcme United Corporation37c709ae-ef37-0b46-e063-6394a90af8612025-06-17WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
application number: M003
Lacura Moisturizing Hand SanitizerETHYL ALCOHOL 62%Aldidafa52fe-42e6-2c21-e053-2995a90a413f2025-06-13WarningsExact identifier
application number: M003
RefresherALCOHOLJao Limited1debc8ca-2ea4-40c3-ad1e-8c1dc763d0f82025-06-13WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltd34769116-2520-f862-e063-6394a90a59492025-06-11WarningsExact 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