Home NDC 65616-009 Sterillium Comfort
Product NDC 65616-009
11-digit product format 656160009
Labeler code 65616
Product ID 65616-009_3404a277-8586-6960-e063-6294a90ad27e
Type HUMAN OTC DRUG
Nonproprietary name Alcohol
Dosage form GEL
Route TOPICAL
Labeler BODE Chemie GmbH
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-31
Substance ALCOHOL
Active strength 85 mL/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Comfort
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 85 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1041851 Internal RxNorm 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 65616-009-06 Sterillium Comfort 1000 mL in 1 BOTTLE, PUMP GEL 1000 8 65616-009-07 Sterillium Comfort 1000 mL in 1 BOTTLE, PUMP GEL 1000 8 65616-009-09 Sterillium Comfort 475 mL in 1 BOTTLE, PUMP GEL 475 8 65616-009-10 Sterillium Comfort 50 mL in 1 BOTTLE, PLASTIC GEL 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65616-009 STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH] 8 Current NDC, Legacy NDC, 4 package rows 20250502_8efc9f4e-3b20-60ba-e053-2995a90af8b1.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65616-009-06 65616000906 1000 mL in 1 BOTTLE, PUMP (65616-009-06) 1000 ml 2019-07-31 0000-00-00 No No Current 65616-009-07 65616000907 1000 mL in 1 BOTTLE, PUMP (65616-009-07) 1000 ml 2025-04-30 No No Current 65616-009-09 65616000909 475 mL in 1 BOTTLE, PUMP (65616-009-09) 475 ml 2019-07-31 0000-00-00 No No Current 65616-009-10 65616000910 50 mL in 1 BOTTLE, PLASTIC (65616-009-10) 50 ml 2019-07-31 0000-00-00 No No Current