Hand Sanitizer

Product NDC
76539-111
Requested package NDC
76539-111-55
11-digit product format
765390111
Labeler code
76539
Product ID
76539-111_a463120f-4df4-268d-e053-2995a90ac508
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Kenher Servicios Industriales, S.de R.L. 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 packagepackage76539-11176539-111-55IInactivated 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
76539-111-10Hand Sanitizer1000 mL in 1 BOTTLEGEL10002
76539-111-38Hand Sanitizer3800 mL in 1 BOTTLEGEL38002
76539-111-40Hand Sanitizer4000 mL in 1 BOTTLEGEL40002
76539-111-50Hand Sanitizer500 mL in 1 BOTTLEGEL5002
76539-111-55Hand Sanitizer550 mL in 1 BOTTLEGEL5502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76539-111HAND SANITIZER (ALCOHOL) GEL [KENHER SERVICIOS INDUSTRIALES, S.DE R.L. DE C.V.]2Legacy NDC, 5 package rows20200429_a462fc18-8669-1430-e053-2995a90a4cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa462fc18-8669-1430-e053-2995a90a4cbb2
581662ethanol 0.7 ML/ML Topical GelSCDa462fc18-8669-1430-e053-2995a90a4cbb2
581662ethanol 70 % Topical GelSYa462fc18-8669-1430-e053-2995a90a4cbb2
581662ethyl alcohol 70 % Topical GelSYa462fc18-8669-1430-e053-2995a90a4cbb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76539-111-5576539011155550 mL in 1 BOTTLE (76539-111-55) 550 ml2020-03-300000-00-00NoNoCurrent