FDA.reportPublic FDA data

THE PENINSULA HAND SANITIZER

Product NDC
80176-004
Requested package NDC
80176-004-01
11-digit product format
801760004
Labeler code
80176
Product ID
80176-004_d92a17c4-981d-5fb1-e053-2a95a90a9ca1
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
CERCI KOZMETIK VE OTEL EKIPMANLARI PAZARLAMA IC VE DIS TICARET LIMITED SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-03-10
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage80176-00480176-004-01IInactivated 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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
80176-004-012025-01-30C16284748780-12cef2736-b30b-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80176-004-01THE PENINSULA HAND SANITIZER15 mL in 1 TUBEGEL152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80176-004THE PENINSULA HAND SANITIZER (ETHYL ALCOHOL) GEL [CERCI KOZMETIK VE OTEL EKIPMANLARI PAZARLAMA IC VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20231031_6ffb952e-7825-4ffe-8e9d-8f8fc77d141a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN6ffb952e-7825-4ffe-8e9d-8f8fc77d141a2
581662ethanol 0.7 ML/ML Topical GelSCD6ffb952e-7825-4ffe-8e9d-8f8fc77d141a2
581662ethanol 70 % Topical GelSY6ffb952e-7825-4ffe-8e9d-8f8fc77d141a2
581662ethyl alcohol 70 % Topical GelSY6ffb952e-7825-4ffe-8e9d-8f8fc77d141a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80176-004-018017600040115 mL in 1 TUBE (80176-004-01) 15 ml2022-03-100000-00-00NoNoCurrent