Gel Hand Sanitizer

Product NDC
76585-003
Requested package NDC
76585-003-14
11-digit product format
765850003
Labeler code
76585
Product ID
76585-003_a7fcbcc2-5313-4d41-e053-2a95a90a38e2
Type
HUMAN OTC DRUG
Nonproprietary name
Gel Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Marquis Extraction Technology LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-04
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 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 packagepackage76585-00376585-003-14IInactivated 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
76585-003-11Gel Hand Sanitizer473 mL in 1 BOTTLEGEL4732
76585-003-12Gel Hand Sanitizer1040875 mL in 1 BOTTLEGEL10408752
76585-003-13Gel Hand Sanitizer236 mL in 1 BOTTLEGEL2362
76585-003-14Gel Hand Sanitizer946 mL in 1 BOTTLEGEL9462
76585-003-15Gel Hand Sanitizer12113 mL in 1 BOTTLEGEL121132
76585-003-16Gel Hand Sanitizer18927 mL in 1 BOTTLEGEL189272
76585-003-17Gel Hand Sanitizer3785 mL in 1 BOTTLEGEL37852
76585-003-18Gel Hand Sanitizer355 mL in 1 BOTTLEGEL3552
76585-003-20Gel Hand Sanitizer59 mL in 1 BOTTLEGEL592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76585-003GEL HAND SANITIZER GEL [MARQUIS EXTRACTION TECHNOLOGY LLC]2Legacy NDC, 9 package rows20200614_a7a7e50d-ee52-3e44-e053-2a95a90a6803.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa7a7e50d-ee52-3e44-e053-2a95a90a68032
581662ethanol 0.7 ML/ML Topical GelSCDa7a7e50d-ee52-3e44-e053-2a95a90a68032
581662ethanol 70 % Topical GelSYa7a7e50d-ee52-3e44-e053-2a95a90a68032
581662ethyl alcohol 70 % Topical GelSYa7a7e50d-ee52-3e44-e053-2a95a90a68032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76585-003-1476585000314946 mL in 1 BOTTLE (76585-003-14) 946 ml2020-06-040000-00-00NoNoCurrent