FDA.reportPublic FDA data

KLEAN 5 IN 1 Sanitizer

Product NDC
82122-003
Requested package NDC
82122-003-01
11-digit product format
821220003
Labeler code
82122
Product ID
82122-003_61c51af4-4ec4-4dd6-be41-d4c2fc1f5a71
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
DepilatoCosmetics SAS
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-08-31
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage82122-00382122-003-01IInactivated by FDA2026-11-06

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 · 15 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82122-003-012023-01-30C16284748780-1f386c649-bf26-0266-e053-dadaa90a7c1ab6b24b03-aa64-4d1c-8f1a-6a283e028f93

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82122-003-01KLEAN 5 IN 1 Sanitizer290 mL in 1 BOTTLE, SPRAYSOLUTION2901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82122-003KLEAN 5 IN 1 SANITIZER (ALCOHOL) SOLUTION [DEPILATOCOSMETICS SAS]1Legacy NDC, 1 package rows20210901_b6b24b03-aa64-4d1c-8f1a-6a283e028f93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNb6b24b03-aa64-4d1c-8f1a-6a283e028f931
1039339ethanol 0.8 ML/ML Topical SolutionSCDb6b24b03-aa64-4d1c-8f1a-6a283e028f931
1039339ethanol 80 % Topical SolutionSYb6b24b03-aa64-4d1c-8f1a-6a283e028f931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82122-003-0182122000301290 mL in 1 BOTTLE, SPRAY (82122-003-01) 290 ml2021-08-310000-00-00NoNoCurrent