Hand Sanitizer

Product NDC
54586-002
Requested package NDC
54586-002-02
11-digit product format
545860002
Labeler code
54586
Product ID
54586-002_ac0984a1-640c-6425-e053-2995a90a1a43
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
GEL
Route
EXTRACORPOREAL
Labeler
Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-04
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
375 mL/500mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage54586-00254586-002-02IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
54586-002-01Hand Sanitizer500 mL in 1 BOTTLEGEL5002
54586-002-02Hand Sanitizer500 mL in 1 BOTTLEGEL5001
54586-002-03Hand Sanitizer500 mL in 1 BOTTLEGEL5001
54586-002-04Hand Sanitizer500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54586-002HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]2Legacy NDC, 1 package rows20200518_a4458ed8-a3ad-1790-e053-2a95a90aee6b.zip
54586-002HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]1Legacy NDC, 1 package rows20200805_ac0a0851-ba86-7f36-e053-2995a90ae391.zip
54586-002HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]1Legacy NDC, 1 package rows20200805_ac0984a1-640b-6425-e053-2995a90a1a43.zip
54586-002HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]1Legacy NDC, 1 package rows20200805_ac0a0851-ba89-7f36-e053-2995a90ae391.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa4458ed8-a3ad-1790-e053-2a95a90aee6b2
1305100ethanol 0.75 ML/ML Topical GelSCDa4458ed8-a3ad-1790-e053-2a95a90aee6b2
1305100ethanol 75 % Topical GelSYa4458ed8-a3ad-1790-e053-2a95a90aee6b2
1305100ethanol 75 % Topical GelPSNac0984a1-640b-6425-e053-2995a90a1a431
1305100ethanol 75 % Topical GelPSNac0a0851-ba86-7f36-e053-2995a90ae3911
1305100ethanol 75 % Topical GelPSNac0a0851-ba89-7f36-e053-2995a90ae3911
1305100ethanol 0.75 ML/ML Topical GelSCDac0984a1-640b-6425-e053-2995a90a1a431
1305100ethanol 0.75 ML/ML Topical GelSCDac0a0851-ba86-7f36-e053-2995a90ae3911
1305100ethanol 0.75 ML/ML Topical GelSCDac0a0851-ba89-7f36-e053-2995a90ae3911
1305100ethanol 75 % Topical GelSYac0984a1-640b-6425-e053-2995a90a1a431
1305100ethanol 75 % Topical GelSYac0a0851-ba86-7f36-e053-2995a90ae3911
1305100ethanol 75 % Topical GelSYac0a0851-ba89-7f36-e053-2995a90ae3911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54586-002-0254586000202500 mL in 1 BOTTLE (54586-002-02) 500 ml2020-08-040000-00-00NoNoCurrent