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 32 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESave-A-Lot Food Stores Ltde279b23d-6779-4f04-a93c-1c2a495596392026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMeijer, Inc.4989f1cd-4555-405a-a5f8-8714d472983c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
application number: M003
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
application number: M003
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
application number: M003
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
application number: M003
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
application number: M003
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
application number: M003
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
application number: M003
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
application number: M003
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact 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