FDA.reportPublic FDA data

International Harbor

Product NDC
79838-003
Requested package NDC
79838-003-03
11-digit product format
798380003
Labeler code
79838
Product ID
79838-003_afdd25ba-fe03-31e9-e053-2a95a90a2c99
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
INTERNATIONAL HARBOR LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79838-00379838-003-03IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79838-003-012021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-022021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-032021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-042021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-052021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)
79838-003-062021-07-23C16284748780-1c7ccaba7-14f7-fd44-e053-dadaa90aa01bInternational Harbor gel Antibacterial (60 ml, 250 ml, 500 ml, 1 l, 1.8 l 1 gal)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79838-003-01International Harbor60 mL in 1 BOTTLEGEL601
79838-003-02International Harbor250 mL in 1 BOTTLEGEL2501
79838-003-03International Harbor500 mL in 1 BOTTLEGEL5001
79838-003-04International Harbor1000 mL in 1 BOTTLEGEL10001
79838-003-05International Harbor1800 mL in 1 BOTTLEGEL18001
79838-003-06International Harbor3785 mL in 1 BOTTLEGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79838-003INTERNATIONAL HARBOR (ALCOHOL) GEL [INTERNATIONAL HARBOR LLC]1Legacy NDC, 6 package rows20200923_afdd2516-7405-c93c-e053-2995a90a8646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNafdd2516-7405-c93c-e053-2995a90a86461
1305100ethanol 0.75 ML/ML Topical GelSCDafdd2516-7405-c93c-e053-2995a90a86461
1305100ethanol 75 % Topical GelSYafdd2516-7405-c93c-e053-2995a90a86461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79838-003-0379838000303500 mL in 1 BOTTLE (79838-003-03) 500 ml2020-03-300000-00-00NoNoCurrent