Biolustre Hygienic Hand Cleansing Gel

Product NDC
80371-104
Requested package NDC
80371-104-01
11-digit product format
803710104
Labeler code
80371
Product ID
80371-104_b069fab5-9825-b5e2-e053-2a95a90a0009
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-29
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 packagepackage80371-10480371-104-01IInactivated 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 · 15 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…

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
80371-104-012023-01-30C16284748780-1f386c64a-14c7-0266-e053-dadaa90a7c1ab069fab5-9824-b5e2-e053-2a95a90a0009
80371-104-022023-01-30C16284748780-1f386c64a-14c7-0266-e053-dadaa90a7c1ab069fab5-9824-b5e2-e053-2a95a90a0009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80371-104-01Biolustre Hygienic Hand Cleansing Gel50 mL in 1 BOTTLE, PLASTICGEL501
80371-104-02Biolustre Hygienic Hand Cleansing Gel100 mL in 1 BOTTLE, PLASTICGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80371-104BIOLUSTRE HYGIENIC HAND CLEANSING GEL (ETHYL ALCOHOL) GEL [KOYUNCU BILISIM TEKNOLOJILERI SANAYI VE TICARET LIMITED SIRKETI]1Legacy NDC, 2 package rows20200929_b069fab5-9824-b5e2-e053-2a95a90a0009.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNb069fab5-9824-b5e2-e053-2a95a90a00091
581662ethanol 0.7 ML/ML Topical GelSCDb069fab5-9824-b5e2-e053-2a95a90a00091
581662ethanol 70 % Topical GelSYb069fab5-9824-b5e2-e053-2a95a90a00091
581662ethyl alcohol 70 % Topical GelSYb069fab5-9824-b5e2-e053-2a95a90a00091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80371-104-018037101040150 mL in 1 BOTTLE, PLASTIC (80371-104-01) 50 ml2020-09-290000-00-00NoNoCurrent