Home NDC 80441-002-15 Sirenol Antiseptic Topical
Product NDC 80441-002
Requested package NDC 80441-002-15
11-digit product format 804410002
Labeler code 80441
Product ID 80441-002_b0a5f86d-ccad-4f88-ab36-ed3013aa5859
Type HUMAN OTC DRUG
Nonproprietary name ALCOHOL
Dosage form GEL
Route TOPICAL
Labeler BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-09-02
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 80 mL/100mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 U Excluded because listing certification expired 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 U Excluded because listing certification expired bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80441-002-01 Sirenol Antiseptic Topical 25 mL in 1 BOTTLE GEL 25 1 80441-002-02 Sirenol Antiseptic Topical 50 mL in 1 BOTTLE GEL 50 1 80441-002-03 Sirenol Antiseptic Topical 100 mL in 1 BOTTLE GEL 100 1 80441-002-04 Sirenol Antiseptic Topical 150 mL in 1 BOTTLE GEL 150 1 80441-002-05 Sirenol Antiseptic Topical 200 mL in 1 BOTTLE GEL 200 1 80441-002-06 Sirenol Antiseptic Topical 250 mL in 1 BOTTLE GEL 250 1 80441-002-07 Sirenol Antiseptic Topical 500 mL in 1 BOTTLE GEL 500 1 80441-002-08 Sirenol Antiseptic Topical 1000 mL in 1 BOTTLE GEL 1000 1 80441-002-09 Sirenol Antiseptic Topical 3785 mL in 1 BOTTLE GEL 3785 1 80441-002-10 Sirenol Antiseptic Topical 5000 mL in 1 BOTTLE GEL 5000 1 80441-002-11 Sirenol Antiseptic Topical 10000 mL in 1 BOTTLE GEL 10000 1 80441-002-12 Sirenol Antiseptic Topical 6 in 1 PACKAGE GEL 6 1 80441-002-12 Sirenol Antiseptic Topical 5 mL in 1 NOT APPLICABLE GEL 5 1 80441-002-13 Sirenol Antiseptic Topical 5 mL in 1 NOT APPLICABLE GEL 5 1 80441-002-13 Sirenol Antiseptic Topical 10 in 1 PACKAGE GEL 10 1 80441-002-14 Sirenol Antiseptic Topical 20 in 1 PACKAGE GEL 20 1 80441-002-14 Sirenol Antiseptic Topical 5 mL in 1 NOT APPLICABLE GEL 5 1 80441-002-15 Sirenol Antiseptic Topical 5 mL in 1 NOT APPLICABLE GEL 5 1 80441-002-15 Sirenol Antiseptic Topical 100 in 1 PACKAGE GEL 100 1 80441-002-16 Sirenol Antiseptic Topical 5 mL in 1 NOT APPLICABLE GEL 5 1 80441-002-16 Sirenol Antiseptic Topical 1000 in 1 PACKAGE GEL 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80441-002 SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) GEL [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI] 1 Legacy NDC, 21 package rows 20200910_f26bfa16-3c9e-45ef-8156-988095b869f6.zip
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 80441-002-15 80441000215 100 NOT APPLICABLE in 1 PACKAGE (80441-002-15) > 5 mL in 1 NOT APPLICABLE 100 not applicable 2020-09-02 0000-00-00 No No Current