Home NDC 65616-008 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 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 Sterillium Rub Fragrance Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 89.5 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65616-008-06 Sterillium Rub Fragrance Free 1000 mL in 1 BOTTLE, PUMP LIQUID 1000 6 65616-008-07 Sterillium Rub Fragrance Free 1000 mL in 1 BOTTLE, PUMP LIQUID 1000 6 65616-008-08 Sterillium Rub Fragrance Free 50 mL in 1 BOTTLE, SPRAY LIQUID 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65616-008 STERILLIUM RUB FRAGRANCE FREE (ALCOHOL) LIQUID [BODE CHEMIE GMBH] 6 Current NDC, Legacy NDC, 3 package rows 20250416_8e73359b-af12-955c-e053-2a95a90a76b6.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65616-008-06 65616000806 1000 mL in 1 BOTTLE, PUMP (65616-008-06) 1000 ml 2019-07-31 0000-00-00 No No Current 65616-008-07 65616000807 1000 mL in 1 BOTTLE, PUMP (65616-008-07) 1000 ml 2025-04-14 No No Current 65616-008-08 65616000808 50 mL in 1 BOTTLE, SPRAY (65616-008-08) 50 ml 2019-07-31 0000-00-00 No No Current