FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
53329-209
11-digit product format
533290209
Labeler code
53329
Product ID
53329-209_4a8e3274-7e1a-8509-e063-6394a90a8149
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-27
Substance
ALCOHOL
Active strength
.879 mg/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
Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.879 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42813b3e-dfae-495c-bffb-bf3862857cb1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-209-12Hand Sanitizer44 mL in 1 BOTTLE, PUMPLIQUID4414
53329-209-37Hand Sanitizer221 mL in 1 BOTTLE, PUMPLIQUID22114
53329-209-74Hand Sanitizer1200 mL in 1 BOTTLELIQUID120014
53329-209-80Hand Sanitizer532 mL in 1 BOTTLE, PUMPLIQUID53214
53329-209-98Hand Sanitizer1000 mL in 1 BOTTLE, PUMPLIQUID100014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-209HAND SANITIZER (ALCOHOL) LIQUID [MEDLINE INDUSTRIES, LP]13Current NDC, Legacy NDC, 5 package rows20240531_42813b3e-dfae-495c-bffb-bf3862857cb1.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
Hand SanitizerALCOHOLMedline Industries, LP42813b3e-dfae-495c-bffb-bf3862857cb12026-02-11WarningsExact identifier
ndc (product): 53329-209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-209-125332902091244 mL in 1 BOTTLE, PUMP (53329-209-12) 44 ml2023-01-01NoNoCurrent
53329-209-3753329020937221 mL in 1 BOTTLE, PUMP (53329-209-37) 221 ml2016-05-270000-00-00NoNoCurrent
53329-209-74533290209741200 mL in 1 BOTTLE (53329-209-74) 1200 ml2023-08-01NoNoCurrent
53329-209-8053329020980532 mL in 1 BOTTLE, PUMP (53329-209-80) 532 ml2016-05-270000-00-00NoNoCurrent
53329-209-98533290209981000 mL in 1 BOTTLE, PUMP (53329-209-98) 1000 ml2016-05-270000-00-00NoNoCurrent