FDA.reportPublic FDA data

Alcohol Prep Pad Non-Sterile

Product NDC
34645-0001
Requested package NDC
34645-0001-1
11-digit product format
346450001
Labeler code
34645
Product ID
34645-0001_085cf04e-cf75-92d5-e063-6394a90a2d9a
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alcohol Prep Pad Non-Sterile
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL.7 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b835128-194a-4527-abd5-c507ca94b197Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0001-1Alcohol Prep Pad Non-Sterile1 in 1 POUCHPATCH14
34645-0001-1Alcohol Prep Pad Non-Sterile0.5 mL in 1 PATCHPATCH0.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0001ALCOHOL PREP PAD NON-STERILE (ISOPROPYL ALCOHOL) PATCH [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_9b835128-194a-4527-abd5-c507ca94b197.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 Prep Pad Non-SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd9b835128-194a-4527-abd5-c507ca94b1972023-10-23WarningsExact identifier
ndc (package): 34645-0001-1
ndc (product): 34645-0001
ndc11 (package): 34645000101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN9b835128-194a-4527-abd5-c507ca94b1974
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD9b835128-194a-4527-abd5-c507ca94b1974
797544isopropyl alcohol 70 % Medicated PadSY9b835128-194a-4527-abd5-c507ca94b1974
797544isopropyl alcohol 70 % Topical ClothSY9b835128-194a-4527-abd5-c507ca94b1974
797544isopropyl alcohol 70 % Topical SwabSY9b835128-194a-4527-abd5-c507ca94b1974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0001-1346450001011 PATCH in 1 POUCH (34645-0001-1) / .5 mL in 1 PATCH1 patch2020-04-300000-00-00NoNoCurrent