HAND SANIZITER

Product NDC
54457-004
Requested package NDC
54457-004-01
11-digit product format
544570004
Labeler code
54457
Product ID
54457-004_a687cd59-bc6b-9e91-e053-2a95a90afa7d
Type
HUMAN OTC DRUG
Nonproprietary name
waterless hand sanitizer
Dosage form
LIQUID
Route
EXTRACORPOREAL
Labeler
Guangzhou Zunai Daily Cosmetics Co.,Ltd
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
45 mL/60mL
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 packagepackage54457-00454457-004-01IInactivated 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 · 19 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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54457-004-012021-07-23C16284748780-1c7ccaba7-1f3b-fd44-e053-dadaa90aa01ba687c0d4-977e-47f4-e053-2995a90a0bb4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54457-004-01HAND SANIZITER60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54457-004HAND SANIZITER (WATERLESS HAND SANITIZER) LIQUID [GUANGZHOU ZUNAI DAILY COSMETICS CO.,LTD]1Legacy NDC, 1 package rows20200527_a687c0d4-977e-47f4-e053-2995a90a0bb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047755ethanol 75 % Topical SolutionPSNa687c0d4-977e-47f4-e053-2995a90a0bb41
1047755ethanol 0.75 ML/ML Topical SolutionSCDa687c0d4-977e-47f4-e053-2995a90a0bb41
1047755ethanol 75 % Topical SolutionSYa687c0d4-977e-47f4-e053-2995a90a0bb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54457-004-015445700040160 mL in 1 BOTTLE (54457-004-01) 60 ml2020-05-260000-00-00NoNoCurrent