FDA.reportPublic FDA data

Sterillium Rub Fragrance Free

Product NDC
65616-008
11-digit product format
656160008
Labeler code
65616
Product ID
65616-008_32be39e9-0c20-1413-e063-6394a90a1dea
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
BODE Chemie GmbH
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-31
Substance
ALCOHOL
Active strength
89.5 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
Sterillium Rub Fragrance Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL89.5 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-008-06Sterillium Rub Fragrance Free1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-008-07Sterillium Rub Fragrance Free1000 mL in 1 BOTTLE, PUMPLIQUID10006
65616-008-08Sterillium Rub Fragrance Free50 mL in 1 BOTTLE, SPRAYLIQUID506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-008STERILLIUM RUB FRAGRANCE FREE (ALCOHOL) LIQUID [BODE CHEMIE GMBH]6Current NDC, Legacy NDC, 3 package rows20250416_8e73359b-af12-955c-e053-2a95a90a76b6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65616-008-06656160008061000 mL in 1 BOTTLE, PUMP (65616-008-06) 1000 ml2019-07-310000-00-00NoNoCurrent
65616-008-07656160008071000 mL in 1 BOTTLE, PUMP (65616-008-07) 1000 ml2025-04-14NoNoCurrent
65616-008-086561600080850 mL in 1 BOTTLE, SPRAY (65616-008-08) 50 ml2019-07-310000-00-00NoNoCurrent