Sirenol Antiseptic Topical

Product NDC
80441-001
Requested package NDC
80441-001-18
11-digit product format
804410001
Labeler code
80441
Product ID
80441-001_b10bfd21-0eea-4784-81e0-505a9a8ae270
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SOLUTION
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80441-00180441-001-18IInactivated by FDA2026-08-03

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 dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01UExcluded because listing certification expiredbd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80441-001-01Sirenol Antiseptic Topical6 in 1 PACKAGESOLUTION61
80441-001-01Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-02Sirenol Antiseptic Topical10 in 1 PACKAGESOLUTION101
80441-001-02Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-03Sirenol Antiseptic Topical20 in 1 PACKAGESOLUTION201
80441-001-03Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-04Sirenol Antiseptic Topical100 in 1 PACKAGESOLUTION1001
80441-001-04Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-05Sirenol Antiseptic Topical5 mL in 1 NOT APPLICABLESOLUTION51
80441-001-05Sirenol Antiseptic Topical1000 in 1 PACKAGESOLUTION10001
80441-001-06Sirenol Antiseptic Topical60 in 1 BOTTLESOLUTION601
80441-001-06Sirenol Antiseptic Topical150 mL in 1 NOT APPLICABLESOLUTION1501
80441-001-07Sirenol Antiseptic Topical80 in 1 BOTTLESOLUTION801
80441-001-07Sirenol Antiseptic Topical200 mL in 1 NOT APPLICABLESOLUTION2001
80441-001-08Sirenol Antiseptic Topical250 mL in 1 NOT APPLICABLESOLUTION2501
80441-001-08Sirenol Antiseptic Topical100 in 1 BOTTLESOLUTION1001
80441-001-09Sirenol Antiseptic Topical25 mL in 1 BOTTLESOLUTION251
80441-001-10Sirenol Antiseptic Topical50 mL in 1 BOTTLESOLUTION501
80441-001-11Sirenol Antiseptic Topical100 mL in 1 BOTTLESOLUTION1001
80441-001-12Sirenol Antiseptic Topical150 mL in 1 BOTTLESOLUTION1501
80441-001-13Sirenol Antiseptic Topical200 mL in 1 BOTTLESOLUTION2001
80441-001-14Sirenol Antiseptic Topical250 mL in 1 BOTTLESOLUTION2501
80441-001-15Sirenol Antiseptic Topical500 mL in 1 BOTTLESOLUTION5001
80441-001-16Sirenol Antiseptic Topical1000 mL in 1 BOTTLESOLUTION10001
80441-001-17Sirenol Antiseptic Topical3785 mL in 1 BOTTLESOLUTION37851
80441-001-18Sirenol Antiseptic Topical5000 mL in 1 BOTTLESOLUTION50001
80441-001-19Sirenol Antiseptic Topical10000 mL in 1 BOTTLESOLUTION100001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80441-001SIRENOL ANTISEPTIC TOPICAL (ALCOHOL) SOLUTION [BM GLOBAL ELEKTRONIK GIDA SANAYI VE DIS TICARET LIMITED SIRKETI]1Legacy NDC, 27 package rows20200910_f26854eb-eec7-477c-9dbf-c13eb089bfa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNf26854eb-eec7-477c-9dbf-c13eb089bfa31
1039339ethanol 0.8 ML/ML Topical SolutionSCDf26854eb-eec7-477c-9dbf-c13eb089bfa31
1039339ethanol 80 % Topical SolutionSYf26854eb-eec7-477c-9dbf-c13eb089bfa31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80441-001-18804410001185000 mL in 1 BOTTLE (80441-001-18) 5000 ml2020-09-020000-00-00NoNoCurrent