FDA.reportPublic FDA data

Skin Cottage 70 Percent Ethyl Alcohol Antiseptic Hand Sanitizer

Product NDC
79468-001
Requested package NDC
79468-001-01
11-digit product format
794680001
Labeler code
79468
Product ID
79468-001_b09d50a5-3e4e-32fa-e053-2995a90a4044
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
KEN-RICH CHEMICAL PRODUCTION SDN. BHD.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-10-15
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
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 packagepackage79468-00179468-001-01IInactivated by FDA2026-10-12

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
79468-001-012026-01-29C16284748780-11030e365-10d6-111a-e063-dadaa90a10e2Skin Cottage 70% Ethyl Alcohol Antiseptic Hand Sanitizer
79468-001-012024-01-30C16284748780-11030e365-10d6-111a-e063-dadaa90a10e2Skin Cottage 70% Ethyl Alcohol Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79468-001-01Skin Cottage 70 Percent Ethyl Alcohol Antiseptic Hand Sanitizer500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79468-001SKIN COTTAGE 70 PERCENT ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER (ALCOHOL) GEL [KEN-RICH CORPORATION SDN. BHD.]4Legacy NDC, 1 package rows20240716_b09d4e16-1993-cdeb-e053-2a95a90ae2db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNb09d4e16-1993-cdeb-e053-2a95a90ae2db4
581662ethanol 0.7 ML/ML Topical GelSCDb09d4e16-1993-cdeb-e053-2a95a90ae2db4
581662ethanol 70 % Topical GelSYb09d4e16-1993-cdeb-e053-2a95a90ae2db4
581662ethyl alcohol 70 % Topical GelSYb09d4e16-1993-cdeb-e053-2a95a90ae2db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79468-001-0179468000101500 mL in 1 BOTTLE (79468-001-01) 500 ml2020-10-150000-00-00NoNoCurrent