FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
81131-001
Requested package NDC
81131-001-03
11-digit product format
811310001
Labeler code
81131
Product ID
81131-001_e5eb3c90-55a4-5490-e053-2995a90a1dbc
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Hubei Flex Daily Chemicals CO., LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-08-17
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
62 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 packagepackage81131-00181131-001-03IInactivated by FDA2026-10-15

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, Related label table
NDCEffectiveRelated label
81131-001-012023-07-2881131-001
81131-001-022023-07-2881131-001
81131-001-032023-07-2881131-001
81131-001-042023-07-2881131-001
81131-001-012022-08-1081131-001
81131-001-022022-08-1081131-001
81131-001-032022-08-1081131-001
81131-001-042022-08-1081131-001
81131-001-012022-07-2981131-001
81131-001-022022-07-2981131-001
81131-001-032022-07-2981131-001
81131-001-042022-07-2981131-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81131-001-01Antibacterial Hand Sanitizer15 mL in 1 BOTTLEGEL152
81131-001-02Antibacterial Hand Sanitizer30 mL in 1 BOTTLEGEL302
81131-001-03Antibacterial Hand Sanitizer35 mL in 1 BOTTLEGEL352
81131-001-04Antibacterial Hand Sanitizer60 mL in 1 BOTTLEGEL602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81131-001ANTIBACTERIAL HAND SANITIZER (ALCOHOL) GEL [HUBEI FLEX DAILY CHEMICALS CO., LTD]2Legacy NDC, 4 package rows20220811_47349a42-08f4-48cd-acc0-0fd541d447be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN47349a42-08f4-48cd-acc0-0fd541d447be2
581660ethanol 0.62 ML/ML Topical GelSCD47349a42-08f4-48cd-acc0-0fd541d447be2
581660ethanol 62 % Topical GelSY47349a42-08f4-48cd-acc0-0fd541d447be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81131-001-038113100010335 mL in 1 BOTTLE (81131-001-03) 35 ml2021-08-170000-00-00NoNoCurrent