Lemon Scented Antiseptic Hand Sanitizer 80 Ethyl Alcohol

Product NDC
82127-002
Requested package NDC
82127-002-02
11-digit product format
821270002
Labeler code
82127
Product ID
82127-002_c83371c4-d68f-31d3-e053-2995a90a4f81
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
H&Y Products LLC dba Kolonya Carre
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-08-01
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage82127-00282127-002-02DDiscontinued by firm2026-10-12

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82127-00282127-002-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage82127-00282127-002-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82127-002LEMON SCENTED ANTISEPTIC HAND SANITIZER 80 ETHYL ALCOHOL (ALCOHOL) LIQUID [H&Y PRODUCTS LLC DBA KOLONYA CARRE]3Legacy NDC20231230_7a3c4686-01c7-4257-bf23-2ad145149a26.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82127-002-02821270002021 BOTTLE, PLASTIC in 1 BOX (82127-002-02) > 90 mL in 1 BOTTLE, PLASTIC2021-08-010000-00-00NoNoCurrent