FDA.reportPublic FDA data

HAND SANITIZER

Product NDC
59541-541
Requested package NDC
59541-541-07
11-digit product format
595410541
Labeler code
59541
Product ID
59541-541_ab02e7a6-9712-e346-e053-2a95a90a1414
Type
HUMAN OTC DRUG
Nonproprietary name
HAND SANITIZER
Dosage form
GEL
Route
TOPICAL
Labeler
Huizhou Yiyani Cosmetic Co., Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
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 packagepackage59541-54159541-541-07IInactivated 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 · 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#

NDC, Related label table
NDCRelated label
59541-541-01HAND SANITIZER
59541-541-02HAND SANITIZER
59541-541-03HAND SANITIZER
59541-541-04HAND SANITIZER
59541-541-05HAND SANITIZER
59541-541-06HAND SANITIZER
59541-541-07HAND SANITIZER
59541-541-08HAND SANITIZER
59541-541-09HAND SANITIZER
59541-541-10HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59541-541-01HAND SANITIZER15 mL in 1 BOTTLEGEL151
59541-541-02HAND SANITIZER20 mL in 1 BOTTLEGEL201
59541-541-03HAND SANITIZER30 mL in 1 BOTTLEGEL301
59541-541-04HAND SANITIZER50 mL in 1 BOTTLEGEL501
59541-541-05HAND SANITIZER100 mL in 1 BOTTLEGEL1001
59541-541-06HAND SANITIZER250 mL in 1 BOTTLEGEL2501
59541-541-07HAND SANITIZER300 mL in 1 BOTTLEGEL3001
59541-541-08HAND SANITIZER500 mL in 1 BOTTLEGEL5001
59541-541-09HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
59541-541-10HAND SANITIZER5000 mL in 1 BOTTLEGEL50001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59541-541HAND SANITIZER GEL [HUIZHOU YIYANI COSMETIC CO., LTD.]1Legacy NDC, 10 package rows20200725_ab02e7a6-9720-e346-e053-2a95a90a1414.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNab02e7a6-9720-e346-e053-2a95a90a14141
1305100ethanol 0.75 ML/ML Topical GelSCDab02e7a6-9720-e346-e053-2a95a90a14141
1305100ethanol 75 % Topical GelSYab02e7a6-9720-e346-e053-2a95a90a14141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59541-541-0759541054107300 mL in 1 BOTTLE (59541-541-07) 300 ml2020-03-300000-00-00NoNoCurrent