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

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
SimplyGreat Antibacterial wet wipes
Listing expiration
2027-12-31

Active Ingredients#

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

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
2ba2162b-941a-481d-e063-6394a90a5464Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimplyGreat Antibacterial wet wipesBENZALKONIUM CHLORIDESimply Great Brands LLC2ba2162b-941a-481d-e063-6394a90a54642026-03-12WarningsExact identifier
ndc (product): 85057-001

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 patch2024-12-28NoNoCurrent
85057-001-028505700010248 PATCH in 1 BAG (85057-001-02) / .00468 g in 1 PATCH48 patch2026-03-20NoNoCurrent