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 30 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
application number: M003
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
application number: M003
Medicated Apricot ScrubSALICYLIC ACIDOld East Main Co.7c9c430b-30d8-4642-85bd-d028a9aa748a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEOld East Main Co.3c823b47-2ab7-4002-9b6f-abf0a3176b442026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
American Red Cross 6oz, 3% Hydrogen PeroxideAMERICAN RED CROSS 6 OZ, 3% HYDROGEN PEROXIDE SPRAYMY IMPORTS USA LLC29299c46-a929-0d92-e063-6294a90a42182026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEChain Drug Marketing Association31e7063e-0ba1-434f-b404-0ec42df634a32026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTUREThe Kroger Co.c70a718f-d51a-455a-9785-ab41c1b1f8b02026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
MedPride SterileBENZALKONIUM CHLORIDEShield Line LLC02f63d50-e4ff-49b6-9f8c-fddceefe65f32026-02-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFI4eee73dd-039e-44a5-b380-21ff32efee222026-02-26Warnings, 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