FDA.reportPublic FDA data

Gel Antiseptic Handwash

Product NDC
81628-693
11-digit product format
816280693
Labeler code
81628
Product ID
81628-693_28c548c6-c3e9-ae1b-e063-6294a90ab1e3
Type
HUMAN OTC DRUG
Nonproprietary name
Gel Antiseptic Handwash
Dosage form
LIQUID
Route
TOPICAL
Labeler
Shop Bee's Wax LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-16
Substance
ALCOHOL
Active strength
67 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gel Antiseptic Handwash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL67 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81628-693-01Gel Antiseptic Handwash118 mL in 1 BOTTLE, PLASTICLIQUID1182
81628-693-02Gel Antiseptic Handwash236 mL in 1 BOTTLE, PLASTICLIQUID2362
81628-693-03Gel Antiseptic Handwash3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81628-693GEL ANTISEPTIC HANDWASH LIQUID [SHOP BEE'S WAX LLC]2Current NDC, Legacy NDC, 3 package rows20241209_bdac168b-5d58-69ba-e053-2995a90aa5a4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81628-693-0181628069301118 mL in 1 BOTTLE, PLASTIC (81628-693-01) 118 ml2020-07-220000-00-00NoNoCurrent
81628-693-0281628069302236 mL in 1 BOTTLE, PLASTIC (81628-693-02) 236 ml2020-07-220000-00-00NoNoCurrent
81628-693-03816280693033785 mL in 1 BOTTLE, PLASTIC (81628-693-03) 3785 ml2020-07-220000-00-00NoNoCurrent