FDA.reportPublic FDA data

Artisanal Hand Sanitizer

Product NDC
77505-000
Requested package NDC
77505-000-20
11-digit product format
775050000
Labeler code
77505
Product ID
77505-000_a5104849-27e9-245b-e053-2a95a90af7f9
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
CUTANEOUS; TOPICAL
Labeler
Mammoth Distilling LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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 packagepackage77505-00077505-000-20IInactivated by FDA2026-10-15

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
77505-000-00Mammoth Distilling Hand Sanitizer
77505-000-10Mammoth Distilling Hand Sanitizer
77505-000-20Mammoth Distilling Hand Sanitizer
77505-000-30Mammoth Distilling Hand Sanitizer
77505-000-50Mammoth Distilling Hand Sanitizer
77505-000-60Mammoth Distilling Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77505-000-00Artisanal Hand Sanitizer3785 mL in 1 BOTTLELIQUID37851
77505-000-10Artisanal Hand Sanitizer18925 mL in 1 PAILLIQUID189251
77505-000-20Artisanal Hand Sanitizer208175 mL in 1 DRUMLIQUID2081751
77505-000-30Artisanal Hand Sanitizer999240 mL in 1 TANKLIQUID9992401
77505-000-50Artisanal Hand Sanitizer19.2 mL in 1 BOTTLELIQUID19.21
77505-000-60Artisanal Hand Sanitizer236.8 mL in 1 BOTTLELIQUID236.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77505-000ARTISANAL HAND SANITIZER (ALCOHOL) LIQUID [MAMMOTH DISTILLING LLC]1Legacy NDC, 6 package rows20200514_a51057b1-4226-a4e3-e053-2995a90a1f80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039339ethanol 80 % Topical SolutionPSNa51057b1-4226-a4e3-e053-2995a90a1f801
1039339ethanol 0.8 ML/ML Topical SolutionSCDa51057b1-4226-a4e3-e053-2995a90a1f801
1039339ethanol 80 % Topical SolutionSYa51057b1-4226-a4e3-e053-2995a90a1f801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77505-000-2077505000020208175 mL in 1 DRUM (77505-000-20) 208175 ml2020-03-300000-00-00NoNoCurrent