FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
75716-678
Requested package NDC
75716-678-02
11-digit product format
757160678
Labeler code
75716
Product ID
75716-678_a3d64349-c27e-b9bc-e053-2995a90a953a
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Qingdao Welhome Co.,Ltd.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-31
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 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 packagepackage75716-67875716-678-02IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
75716-678-01Hand sanitizer
75716-678-02Hand sanitizer
75716-678-03Hand sanitizer
75716-678-04Hand sanitizer
75716-678-05Hand sanitizer
75716-678-06Hand sanitizer
75716-678-07Hand sanitizer
75716-678-08Hand sanitizer
75716-678-09Hand sanitizer
75716-678-10Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75716-678-01Hand Sanitizer30 mL in 1 BOTTLELIQUID301
75716-678-02Hand Sanitizer50 mL in 1 BOTTLELIQUID501
75716-678-03Hand Sanitizer60 mL in 1 BOTTLELIQUID601
75716-678-04Hand Sanitizer248 mL in 1 BOTTLELIQUID2481
75716-678-05Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
75716-678-06Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
75716-678-07Hand Sanitizer200000 mL in 1 DRUMLIQUID2000001
75716-678-08Hand Sanitizer1000000 mL in 1 TANKLIQUID10000001
75716-678-09Hand Sanitizer100 mL in 1 BOTTLELIQUID1001
75716-678-10Hand Sanitizer3800 mL in 1 JUGLIQUID38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75716-678HAND SANITIZER (ALCOHOL) LIQUID [QINGDAO WELHOME CO.,LTD.]1Legacy NDC, 10 package rows20200531_a3dc3dfa-0f74-8554-e053-2a95a90a5fa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNa3dc3dfa-0f74-8554-e053-2a95a90a5fa51
1039339ethanol 0.8 ML/ML Topical SolutionSCDa3dc3dfa-0f74-8554-e053-2a95a90a5fa51
1039339ethanol 80 % Topical SolutionSYa3dc3dfa-0f74-8554-e053-2a95a90a5fa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75716-678-027571606780250 mL in 1 BOTTLE (75716-678-02) 50 ml2020-05-310000-00-00NoNoCurrent