FDA.reportPublic FDA data

Antiseptic Towelette

Product NDC
82264-008
Requested package NDC
82264-008-00
11-digit product format
822640008
Labeler code
82264
Product ID
82264-008_268802fe-d15d-12aa-e063-6394a90a3198
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
UNCHARTED SUPPLY COMPANY, INC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-27
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

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
25840eb7-9317-439f-a8e8-a7d889c060d2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82264-008-00Antiseptic Towelette4 g in 1 APPLICATORCLOTH41
82264-008-00Antiseptic Towelette10 in 1 POUCHCLOTH101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82264-008ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) CLOTH [UNCHARTED SUPPLY COMPANY, INC.]1Current NDC, 2 package rows20241116_25840eb7-9317-439f-a8e8-a7d889c060d2.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
Antiseptic ToweletteBENZALKONIUM CHLORIDEUNCHARTED SUPPLY COMPANY, INC.25840eb7-9317-439f-a8e8-a7d889c060d22024-11-14WarningsExact identifier
ndc (package): 82264-008-00
ndc (product): 82264-008
ndc11 (package): 82264000800

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 0.13 % Topical ClothSY25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 0.13 % Topical SwabSY25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY25840eb7-9317-439f-a8e8-a7d889c060d21
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY25840eb7-9317-439f-a8e8-a7d889c060d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82264-008-008226400080010 APPLICATOR in 1 POUCH (82264-008-00) / 4 g in 1 APPLICATOR10 applicator2024-09-27NoNoCurrent