Hand Sanitizer

Product NDC
64646-043
Requested package NDC
64646-043-23
11-digit product format
646460043
Labeler code
64646
Product ID
64646-043_cb097d2d-bdf0-5939-e053-2995a90afca8
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 packagepackage64646-04364646-043-23IInactivated by FDA2026-09-14

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-043-73Hand Sanitizer1000 mL in 1 BOTTLE, DISPENSINGGEL10002
64646-043-02Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
64646-043-03Hand Sanitizer37800 mL in 1 BOTTLEGEL378001
64646-043-04Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGGEL12501
64646-043-12Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
64646-043-20Hand Sanitizer18900 mL in 1 PAILGEL189001
64646-043-21Hand Sanitizer55000 mL in 1 DRUMGEL550001
64646-043-22Hand Sanitizer208000 mL in 1 DRUMGEL2080001
64646-043-23Hand Sanitizer1000 mL in 1 DRUMGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-043HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]2Legacy NDC, 1 package rows20240202_fa5428f3-1516-d51e-e053-6294a90ad3f8.zip
64646-043HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]1Legacy NDC, 8 package rows20210911_cb09877c-fb37-394c-e053-2995a90a15d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2282911ethanol 71 % Topical GelPSNfa5428f3-1516-d51e-e053-6294a90ad3f82
2282911ethanol 0.71 ML/ML Topical GelSCDfa5428f3-1516-d51e-e053-6294a90ad3f82
2282911ethanol 71 % Topical GelSYfa5428f3-1516-d51e-e053-6294a90ad3f82
2282911ethanol 71 % Topical GelPSNcb09877c-fb37-394c-e053-2995a90a15d81
2282911ethanol 0.71 ML/ML Topical GelSCDcb09877c-fb37-394c-e053-2995a90a15d81
2282911ethanol 71 % Topical GelSYcb09877c-fb37-394c-e053-2995a90a15d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64646-043-23646460043231000 mL in 1 DRUM (64646-043-23) 1000 ml2021-09-100000-00-00NoNoCurrent