Assured Instant Hand Sanitizer

Product NDC
78524-002
Requested package NDC
78524-002-01
11-digit product format
785240002
Labeler code
78524
Product ID
78524-002_2757a4dc-3414-46e3-a7e3-569a7e86a971
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Gianthope Arts Product (Huizhou) Company Limited
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-02
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 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 packagepackage78524-00278524-002-01IInactivated by FDA2026-10-20

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, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78524-002-012022-01-28C16284748780-1d6a99b39-c204-a426-e053-dadaa90af4c22b949b7c-70d9-439e-9dfb-552e2d1b34f0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78524-002-01Assured Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78524-002ASSURED INSTANT HAND SANITIZER (ALCOHOL) GEL [GIANTHOPE ARTS PRODUCT (HUIZHOU) COMPANY LIMITED]1Legacy NDC, 1 package rows20200602_2b949b7c-70d9-439e-9dfb-552e2d1b34f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSN2b949b7c-70d9-439e-9dfb-552e2d1b34f01
902574ethanol 0.65 ML/ML Topical GelSCD2b949b7c-70d9-439e-9dfb-552e2d1b34f01
902574ethyl alcohol 65 % Topical GelSY2b949b7c-70d9-439e-9dfb-552e2d1b34f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78524-002-0178524000201100 mL in 1 BOTTLE (78524-002-01) 100 ml2020-06-020000-00-00NoNoCurrent