FDA.reportPublic FDA data

Sterillium rub fragrance-free

Product NDC
65616-011
11-digit product format
656160011
Labeler code
65616
Product ID
65616-011_4d2a8460-ac82-4556-e063-6294a90a5f34
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
2025-01-15
Substance
ALCOHOL
Active strength
89.5 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sterillium rub fragrance-free
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65616-011-03Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-06Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-07Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-11Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-11Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-12Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-13Sterillium rub fragrance-free500 mL in 1 BOTTLE, PUMPLIQUID5002
65616-011-13Sterillium rub fragrance-free8 in 1 CARTONLIQUID82
65616-011-14Sterillium rub fragrance-free2 in 1 CARTONLIQUID22
65616-011-14Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-15Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-15Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-17Sterillium rub fragrance-free4 in 1 CARTONLIQUID42
65616-011-18Sterillium rub fragrance-free1000 mL in 1 BOTTLE, PUMPLIQUID10002
65616-011-18Sterillium rub fragrance-free8 in 1 CARTONLIQUID82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65616-011STERILLIUM RUB FRAGRANCE-FREE (ALCOHOL) LIQUID [BODE CHEMIE GMBH]1Current NDC, 17 package rows20250122_2bc46854-fe65-782b-e063-6294a90a79af.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65616-011-0365616001103500 mL in 1 BOTTLE, PUMP (65616-011-03) 500 ml2025-01-15NoNoCurrent
65616-011-06656160011061000 mL in 1 BOTTLE, PUMP (65616-011-06) 1000 ml2025-01-15NoNoCurrent
65616-011-07656160011071000 mL in 1 BOTTLE, PUMP (65616-011-07) 1000 ml2026-03-16NoNoCurrent
65616-011-11656160011112 BOTTLE, PUMP in 1 CARTON (65616-011-11) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-12656160011124 BOTTLE, PUMP in 1 CARTON (65616-011-12) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-13656160011138 BOTTLE, PUMP in 1 CARTON (65616-011-13) / 500 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-14656160011142 BOTTLE, PUMP in 1 CARTON (65616-011-14) / 1000 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-15656160011154 BOTTLE, PUMP in 1 CARTON (65616-011-15) / 1000 mL in 1 BOTTLE, PUMP2025-01-15NoNoCurrent
65616-011-17656160011174 BOTTLE, PUMP in 1 CARTON (65616-011-17) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent
65616-011-18656160011188 BOTTLE, PUMP in 1 CARTON (65616-011-18) / 1000 mL in 1 BOTTLE, PUMP2026-03-16NoNoCurrent