FDA.reportPublic FDA data

ServClean Gel Hand Sanitizer

Product NDC
64646-380
Requested package NDC
64646-380-20
11-digit product format
646460380
Labeler code
64646
Product ID
64646-380_caf4e3a9-6cb5-a776-e053-2a95a90aee1b
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Charlotte Products Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-09-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
71 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 packagepackage64646-38064646-380-20IInactivated 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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 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
64646-380-022024-07-22SC Gel Hand Sanitizer
64646-380-032024-07-22SC Gel Hand Sanitizer
64646-380-042024-07-22SC Gel Hand Sanitizer
64646-380-122024-07-22SC Gel Hand Sanitizer
64646-380-202024-07-22SC Gel Hand Sanitizer
64646-380-212024-07-22SC Gel Hand Sanitizer
64646-380-222024-07-22SC Gel Hand Sanitizer
64646-380-232024-07-22SC Gel Hand Sanitizer
64646-380-022023-01-30SC Gel Hand Sanitizer
64646-380-032023-01-30SC Gel Hand Sanitizer
64646-380-042023-01-30SC Gel Hand Sanitizer
64646-380-122023-01-30SC Gel Hand Sanitizer
64646-380-202023-01-30SC Gel Hand Sanitizer
64646-380-212023-01-30SC Gel Hand Sanitizer
64646-380-222023-01-30SC Gel Hand Sanitizer
64646-380-232023-01-30SC Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-380-02ServClean Gel Hand Sanitizer2000 mL in 1 BOTTLEGEL20002
64646-380-03ServClean Gel Hand Sanitizer3780 mL in 1 BOTTLEGEL37802
64646-380-04ServClean Gel Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGGEL12502
64646-380-12ServClean Gel Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
64646-380-20ServClean Gel Hand Sanitizer18900 mL in 1 PAILGEL189002
64646-380-21ServClean Gel Hand Sanitizer55000 mL in 1 DRUMGEL550002
64646-380-22ServClean Gel Hand Sanitizer208000 mL in 1 DRUMGEL2080002
64646-380-23ServClean Gel Hand Sanitizer1000000 mL in 1 DRUMGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-380SERVCLEAN GEL HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]2Legacy NDC, 8 package rows20240724_caf4dba6-db03-2a91-e053-2995a90a8d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2282911ethanol 71 % Topical GelPSNcaf4dba6-db03-2a91-e053-2995a90a8d692
2282911ethanol 0.71 ML/ML Topical GelSCDcaf4dba6-db03-2a91-e053-2995a90a8d692
2282911ethanol 71 % Topical GelSYcaf4dba6-db03-2a91-e053-2995a90a8d692

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64646-380-206464603802018900 mL in 1 PAIL (64646-380-20) 18900 ml2021-09-100000-00-00NoNoCurrent