FDA.reportPublic FDA data

SimplyGreat Antibacterial wet wipes

Product NDC
85057-001
11-digit product format
850570001
Labeler code
85057
Product ID
85057-001_4ca361f8-2a06-e041-e063-6394a90acb54
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Simply Great Brands LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-28
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SimplyGreat Antibacterial wet wipes
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85057-001-01SimplyGreat Antibacterial wet wipes40 in 1 BAGCLOTH403
85057-001-01SimplyGreat Antibacterial wet wipes0.00468 g in 1 PATCHCLOTH0.004683
85057-001-02SimplyGreat Antibacterial wet wipes0.00468 g in 1 PATCHCLOTH0.004683
85057-001-02SimplyGreat Antibacterial wet wipes48 in 1 BAGCLOTH483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85057-001SIMPLYGREAT ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [SIMPLY GREAT BRANDS LLC]1Current NDC, 4 package rows20250117_2ba2162b-941a-481d-e063-6394a90a5464.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 0.13 % Topical ClothSY2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 0.13 % Topical SwabSY2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2ba2162b-941a-481d-e063-6394a90a54643
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2ba2162b-941a-481d-e063-6394a90a54643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85057-001-018505700010140 PATCH in 1 BAG (85057-001-01) / .00468 g in 1 PATCH40 patch2024-12-28NoNoHistorical
85057-001-028505700010248 PATCH in 1 BAG (85057-001-02) / .00468 g in 1 PATCH48 patch2026-03-20NoNoHistorical