FDA.reportPublic FDA data

Alcohol Cleansing Wipe

Product NDC
83165-001
11-digit product format
831650001
Labeler code
83165
Product ID
83165-001_52e25ae8-4278-3a89-e063-6294a90aa2bc
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
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
ALCOHOL
Active strength
.7 mL/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
Alcohol Cleansing Wipe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f278a911-ac4e-6868-e053-2a95a90a2ee3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83165-001-00Alcohol Cleansing Wipe0.62 mL in 1 PATCHCLOTH0.624

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83165-001ALCOHOL CLEANSING WIPE (ALCOHOL) CLOTH [HUBEI FANJIAN MEDICAL PRODUCT CO.,LTD]3Current NDC, 1 package rows20231111_f278a911-ac4e-6868-e053-2a95a90a2ee3.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
Alcohol Cleansing WipeALCOHOLHubei Fanjian Medical Product Co.,Ltdf278a911-ac4e-6868-e053-2a95a90a2ee32026-05-28WarningsExact identifier
ndc (product): 83165-001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489307ethanol 70 % Medicated PadPSNf278a911-ac4e-6868-e053-2a95a90a2ee34
1489307ethanol 0.7 ML/ML Medicated PadSCDf278a911-ac4e-6868-e053-2a95a90a2ee34
1489307ethanol 70 % Medicated PadSYf278a911-ac4e-6868-e053-2a95a90a2ee34
1489307ethanol 70 % Medicated WipesSYf278a911-ac4e-6868-e053-2a95a90a2ee34
1489307ethyl alcohol 70 % ClothSYf278a911-ac4e-6868-e053-2a95a90a2ee34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83165-001-0083165000100.62 mL in 1 PATCH (83165-001-00) 2023-01-14NoNoCurrent