Hand Sanitizer

Product NDC
81309-004
Requested package NDC
81309-004-03
11-digit product format
813090004
Labeler code
81309
Product ID
81309-004_bbbed9d2-b630-237f-e053-2995a90acd52
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
LYW BIOTECH CO LIMITED GUANGZHOU
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-02-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 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 packagepackage81309-00481309-004-03IInactivated 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 · 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
81309-004-01Hand Sanitizer30 mL in 1 BOTTLE, PLASTICGEL301
81309-004-02Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL601
81309-004-03Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1001
81309-004-04Hand Sanitizer120 mL in 1 BOTTLE, PLASTICGEL1201
81309-004-05Hand Sanitizer250 mL in 1 BOTTLE, PLASTICGEL2501
81309-004-06Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5001
81309-004-07Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICGEL10001
81309-004-08Hand Sanitizer1500 mL in 1 BOTTLE, PLASTICGEL15001
81309-004-09Hand Sanitizer2000 mL in 1 BOTTLE, PLASTICGEL20001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81309-004HAND SANITIZER (ETHYL ALCOHOL) GEL [LYW BIOTECH CO LIMITED GUANGZHOU]1Legacy NDC, 9 package rows20210222_bbbed9d2-b62f-237f-e053-2995a90acd52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNbbbed9d2-b62f-237f-e053-2995a90acd521
581660ethanol 0.62 ML/ML Topical GelSCDbbbed9d2-b62f-237f-e053-2995a90acd521
581660ethanol 62 % Topical GelSYbbbed9d2-b62f-237f-e053-2995a90acd521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81309-004-0381309000403100 mL in 1 BOTTLE, PLASTIC (81309-004-03) 100 ml2021-02-010000-00-00NoNoCurrent