FDA.reportPublic FDA data

FUBU Antiseptic Hand Sanitizer Wipes

Product NDC
81226-000
Requested package NDC
81226-000-01
11-digit product format
812260000
Labeler code
81226
Product ID
81226-000_b6ac652a-ed82-5aab-e053-2a95a90a139a
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
TITUS KOZMETIK ARGE SANAYI VE TICARET LIMITED SIRKETI
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 packagepackage81226-00081226-000-01IInactivated by FDA2026-10-05

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81226-000-012022-01-28C16284748780-1d6a99b3a-00e3-a426-e053-dadaa90af4c2FUBU Antiseptic Hand Sanitizer Wipes
81226-000-022022-01-28C16284748780-1d6a99b3a-00e3-a426-e053-dadaa90af4c2FUBU Antiseptic Hand Sanitizer Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81226-000-01FUBU Antiseptic Hand Sanitizer Wipes15 in 1 POUCHCLOTH151
81226-000-01FUBU Antiseptic Hand Sanitizer Wipes1.8 mL in 1 PATCHCLOTH1.81
81226-000-02FUBU Antiseptic Hand Sanitizer Wipes72 in 1 POUCHCLOTH721
81226-000-02FUBU Antiseptic Hand Sanitizer Wipes3.47 mL in 1 PATCHCLOTH3.471

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81226-000FUBU ANTISEPTIC HAND SANITIZER WIPES (BENZALKONIUM CHLORIDE) CLOTH [TITUS KOZMETIK ARGE SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 4 package rows20210101_b6ac6528-f4ad-5abb-e053-2a95a90a1b1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 0.13 % Topical ClothSYb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 0.13 % Topical SwabSYb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYb6ac6528-f4ad-5abb-e053-2a95a90a1b1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81226-000-018122600000115 PATCH in 1 POUCH (81226-000-01) > 1.8 mL in 1 PATCH15 patch2021-01-010000-00-00NoNoCurrent