FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
79078-002
Requested package NDC
79078-002-09
11-digit product format
790780002
Labeler code
79078
Product ID
79078-002_a8d98511-f37b-76c3-e053-2a95a90a9bd3
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Articulos Medicos Brooks, S.A. de C.V.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
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 packagepackage79078-00279078-002-09IInactivated 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#

NDC, Related label table
NDCRelated label
79078-002-01a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-02a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-03a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-04a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-05a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-06a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-07a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-08a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-09a8d98511-f389-76c3-e053-2a95a90a9bd3
79078-002-10a8d98511-f389-76c3-e053-2a95a90a9bd3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79078-002-01Hand Sanitizer60 mL in 1 BOTTLEGEL601
79078-002-02Hand Sanitizer236.58 mL in 1 BOTTLEGEL236.581
79078-002-03Hand Sanitizer250 mL in 1 BOTTLEGEL2501
79078-002-04Hand Sanitizer473.1 mL in 1 BOTTLEGEL473.11
79078-002-05Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79078-002-06Hand Sanitizer1000 mL in 1 BOTTLEGEL10001
79078-002-07Hand Sanitizer3785 mL in 1 BOTTLEGEL37851
79078-002-08Hand Sanitizer5000 mL in 1 BOTTLEGEL50001
79078-002-09Hand Sanitizer200000 mL in 1 CONTAINERGEL2000001
79078-002-10Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79078-002HAND SANITIZER (ALCOHOL) GEL [ARTICULOS MEDICOS BROOKS, S.A. DE C.V.]1Legacy NDC, 10 package rows20200625_a8d98511-f389-76c3-e053-2a95a90a9bd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa8d98511-f389-76c3-e053-2a95a90a9bd31
581662ethanol 0.7 ML/ML Topical GelSCDa8d98511-f389-76c3-e053-2a95a90a9bd31
581662ethanol 70 % Topical GelSYa8d98511-f389-76c3-e053-2a95a90a9bd31
581662ethyl alcohol 70 % Topical GelSYa8d98511-f389-76c3-e053-2a95a90a9bd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79078-002-0979078000209200000 mL in 1 CONTAINER (79078-002-09) 200000 ml2020-03-300000-00-00NoNoCurrent