FDA.reportPublic FDA data

Jianerkang Wipes

Product NDC
34645-0004
11-digit product format
346450004
Labeler code
34645
Product ID
34645-0004_085ce1b9-2652-8067-e063-6294a90afc04
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Substance
ALCOHOL
Active strength
.75 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
Jianerkang Wipes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.75 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
1307051Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a49afe9a-3eaa-401b-e053-2995a90a9245Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0004-1Jianerkang Wipes10.466 mL in 1 POUCHCLOTH10.4663
34645-0004-1Jianerkang Wipes50 in 1 BAGCLOTH503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0004JIANERKANG WIPES (ALCOHOL) CLOTH [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231023_a49afe9a-3eaa-401b-e053-2995a90a9245.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
Jianerkang WipesALCOHOLJianerkang Medical Co., Ltda49afe9a-3eaa-401b-e053-2995a90a92452023-10-23WarningsExact identifier
ndc (product): 34645-0004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307051ethanol 75 % Medicated PadPSNa49afe9a-3eaa-401b-e053-2995a90a92453
1307051ethanol 0.75 ML/ML Medicated PadSCDa49afe9a-3eaa-401b-e053-2995a90a92453
1307051ethanol 75 % Hand Sanitizer WipesSYa49afe9a-3eaa-401b-e053-2995a90a92453
1307051ethyl alcohol 75 % Topical ClothSYa49afe9a-3eaa-401b-e053-2995a90a92453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0004-13464500040150 POUCH in 1 BAG (34645-0004-1) / 10.466 mL in 1 POUCH50 pouch2020-04-300000-00-00NoNoCurrent