FDA.reportPublic FDA data

ServClean Foaming Hand Sanitizer

Product NDC
64646-082
Requested package NDC
64646-082-12
11-digit product format
646460082
Labeler code
64646
Product ID
64646-082_ef67a2b3-6ae0-654d-e053-2995a90acf33
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Charlotte Products Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-09-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage64646-08264646-082-12IInactivated 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 · 5 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
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, Related label table
NDCEffectiveRelated label
64646-082-012026-01-29ServClean Foaming Hand Sanitizer
64646-082-032026-01-29ServClean Foaming Hand Sanitizer
64646-082-042026-01-29ServClean Foaming Hand Sanitizer
64646-082-122026-01-29ServClean Foaming Hand Sanitizer
64646-082-012024-10-29ServClean Foaming Hand Sanitizer
64646-082-042024-10-29ServClean Foaming Hand Sanitizer
64646-082-122024-10-29ServClean Foaming Hand Sanitizer
64646-082-012024-01-30ServClean Foaming Hand Sanitizer
64646-082-042024-01-30ServClean Foaming Hand Sanitizer
64646-082-122024-01-30ServClean Foaming Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-082-01ServClean Foaming Hand Sanitizer500 mL in 1 BOTTLE, PUMPSOLUTION5004
64646-082-03ServClean Foaming Hand Sanitizer3780 mL in 1 BOTTLE, DISPENSINGSOLUTION37804
64646-082-04ServClean Foaming Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGSOLUTION12504
64646-082-12ServClean Foaming Hand Sanitizer575 mL in 1 BOTTLE, PUMPSOLUTION5754

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-082SERVCLEAN FOAMING HAND SANITIZER (ALCOHOL) SOLUTION [CHARLOTTE PRODUCTS LTD.]4Legacy NDC, 4 package rows20241031_caf552f2-01fe-0fd4-e053-2a95a90ad35e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1098198ethanol 75 % Topical FoamPSNcaf552f2-01fe-0fd4-e053-2a95a90ad35e4
1098198ethanol 0.75 ML/ML Topical FoamSCDcaf552f2-01fe-0fd4-e053-2a95a90ad35e4
1098198ethanol 75 % Topical FoamSYcaf552f2-01fe-0fd4-e053-2a95a90ad35e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64646-082-1264646008212575 mL in 1 BOTTLE, PUMP (64646-082-12) 575 ml2022-12-090000-00-00NoNoCurrent