FDA.reportPublic FDA data

Alcohol Swabstick

Product NDC
34645-0016
Requested package NDC
34645-0016-1
11-digit product format
346450016
Labeler code
34645
Product ID
34645-0016_085ec0ff-b5c2-2628-e063-6294a90ade13
Type
HUMAN OTC DRUG
Nonproprietary name
ISOPROPYL ALCOHOL
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-01
Substance
ISOPROPYL ALCOHOL
Active strength
70 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 Swabstick
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 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 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
b576911b-bbf2-4ce7-a94a-29bbf719f205Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0016-1Alcohol Swabstick1 in 1 POUCHSWAB12
34645-0016-1Alcohol Swabstick2 g in 1 APPLICATORSWAB22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0016ALCOHOL SWABSTICK (ISOPROPYL ALCOHOL) SWAB [JIANERKANG MEDICAL CO., LTD]2Current NDC, Legacy NDC, 2 package rows20231024_b576911b-bbf2-4ce7-a94a-29bbf719f205.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 SwabstickISOPROPYL ALCOHOLJianerkang Medical Co., Ltdb576911b-bbf2-4ce7-a94a-29bbf719f2052023-10-23WarningsExact identifier
ndc (package): 34645-0016-1
ndc (product): 34645-0016
ndc11 (package): 34645001601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSNb576911b-bbf2-4ce7-a94a-29bbf719f2052
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDb576911b-bbf2-4ce7-a94a-29bbf719f2052
797544isopropyl alcohol 70 % Medicated PadSYb576911b-bbf2-4ce7-a94a-29bbf719f2052
797544isopropyl alcohol 70 % Topical ClothSYb576911b-bbf2-4ce7-a94a-29bbf719f2052
797544isopropyl alcohol 70 % Topical SwabSYb576911b-bbf2-4ce7-a94a-29bbf719f2052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-0016-1346450016011 APPLICATOR in 1 POUCH (34645-0016-1) / 2 g in 1 APPLICATOR1 applicator2021-08-010000-00-00NoNoCurrent