Home NDC 65616-007-03 Sterillium Med
Product NDC 65616-007
Requested package NDC 65616-007-03
11-digit product format 656160007
Labeler code 65616
Product ID 65616-007_34048363-5c61-6d6e-e063-6294a90aa516
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 Med
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 65616-007-03 Sterillium Med 500 mL in 1 BOTTLE, PUMP LIQUID 500 6 65616-007-06 Sterillium Med 1000 mL in 1 BOTTLE, PUMP LIQUID 1000 6 65616-007-07 Sterillium Med 1000 mL in 1 BOTTLE, PUMP LIQUID 1000 6 65616-007-08 Sterillium Med 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 65616-007 STERILLIUM MED (ALCOHOL) LIQUID [BODE CHEMIE GMBH] 6 Current NDC, Legacy NDC, 4 package rows 20250502_8d80d5fd-7869-c551-e053-2995a90af2a9.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 65616-007-03 65616000703 500 mL in 1 BOTTLE, PUMP (65616-007-03) 500 ml 2019-07-31 0000-00-00 No No Current