FDA.reportPublic FDA data

Polar Pure Hand Sanitizer

Product NDC
80608-000
11-digit product format
806080000
Labeler code
80608
Product ID
80608-000_b17a0c22-6e10-6335-e053-2a95a90a6aa8
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
11569635 Canada Inc
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80608-000-012022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-022022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-032022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-042022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer
80608-000-052022-01-28C16284748780-1d6a99b39-e39c-a426-e053-dadaa90af4c2Polar Pure Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80608-000-01Polar Pure Hand Sanitizer59 mL in 1 BOTTLELIQUID591
80608-000-02Polar Pure Hand Sanitizer236 mL in 1 BOTTLELIQUID2361
80608-000-03Polar Pure Hand Sanitizer500 mL in 1 BOTTLELIQUID5001
80608-000-04Polar Pure Hand Sanitizer1000 mL in 1 BOTTLELIQUID10001
80608-000-05Polar Pure Hand Sanitizer4000 mL in 1 BOTTLELIQUID40001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80608-000POLAR PURE HAND SANITIZER (ALCOHOL) LIQUID [11569635 CANADA INC]1Legacy NDC, 5 package rows20201022_b17a0658-04b7-5d88-e053-2a95a90ae0b4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80608-000-018060800000159 mL in 1 BOTTLE (80608-000-01) 59 ml2020-09-010000-00-00NoNoCurrent
80608-000-0280608000002236 mL in 1 BOTTLE (80608-000-02) 236 ml2020-09-010000-00-00NoNoCurrent
80608-000-0380608000003500 mL in 1 BOTTLE (80608-000-03) 500 ml2020-09-010000-00-00NoNoCurrent
80608-000-04806080000041000 mL in 1 BOTTLE (80608-000-04) 1000 ml2020-09-010000-00-00NoNoCurrent
80608-000-05806080000054000 mL in 1 BOTTLE (80608-000-05) 4000 ml2020-09-010000-00-00NoNoCurrent