FDA.reportPublic FDA data

Antiseptic Wipe

Product NDC
83165-002
Requested package NDC
83165-002-00
11-digit product format
831650002
Labeler code
83165
Product ID
83165-002_52e2ab18-4776-6dae-e063-6394a90abc3d
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Hubei Fanjian Medical Product Co.,Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-14
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
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 Wipe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

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
f278cdbc-ab0a-6d6a-e053-2995a90a74afAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83165-002-00Antiseptic Wipe0.62 mL in 1 PATCHCLOTH0.624

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83165-002ANTISEPTIC WIPE (BENZALKONIUM CHLORIDE) CLOTH [HUBEI FANJIAN MEDICAL PRODUCT CO.,LTD]3Current NDC, 1 package rows20231111_f278cdbc-ab0a-6d6a-e053-2995a90a74af.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 WipeBENZALKONIUM CHLORIDEHubei Fanjian Medical Product Co.,Ltdf278cdbc-ab0a-6d6a-e053-2995a90a74af2026-05-28WarningsExact identifier
ndc (package): 83165-002-00
ndc (product): 83165-002
ndc11 (package): 83165000200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 0.13 % Topical ClothSYf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 0.13 % Topical SwabSYf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYf278cdbc-ab0a-6d6a-e053-2995a90a74af4
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYf278cdbc-ab0a-6d6a-e053-2995a90a74af4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83165-002-0083165000200.62 mL in 1 PATCH (83165-002-00) 2023-01-14NoNoCurrent