Home NDC 65616-010-07 Sterillium comfort
Product NDC 65616-010
Requested package NDC 65616-010-07
11-digit product format 656160010
Labeler code 65616
Product ID 65616-010_4cc0e8b6-8640-d9a6-e063-6294a90a9caf
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 2025-02-03
Substance ALCOHOL
Active strength 85 mL/100mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sterillium comfort
Listing expiration 2027-12-31
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 Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65616-010 STERILLIUM COMFORT (ALCOHOL) GEL [BODE CHEMIE GMBH] 1 Current NDC, 12 package rows 20250205_2d48dab8-f70a-a2b5-e063-6294a90a1456.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65616-010-07 65616001007 1000 mL in 1 BOTTLE, PUMP (65616-010-07) 1000 ml 2026-03-16 No No Current