FDA.reportPublic FDA data

Alcohol Preps Sterile

Product NDC
34645-0006
11-digit product format
346450006
Labeler code
34645
Product ID
34645-0006_085ce5e1-bb0b-a353-e063-6394a90a5721
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
ISOPROPYL ALCOHOL
Active strength
.7 mL/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
Alcohol Preps Sterile
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65c8f4de-6516-4caa-a458-228b7b4f6f78Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0006-1Alcohol Preps Sterile0.4 g in 1 PATCHCLOTH0.44
34645-0006-1Alcohol Preps Sterile1 in 1 POUCHCLOTH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0006ALCOHOL PREPS STERILE (ISOPROPYL ALCOHOL) CLOTH [JIANERKANG MEDICAL CO., LTD]4Current NDC, Legacy NDC, 2 package rows20231023_65c8f4de-6516-4caa-a458-228b7b4f6f78.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 Preps SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltd65c8f4de-6516-4caa-a458-228b7b4f6f782023-10-23WarningsExact identifier
ndc (product): 34645-0006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0006-1346450006011 PATCH in 1 POUCH (34645-0006-1) / .4 g in 1 PATCH1 patch2020-08-010000-00-00NoNoCurrent