FDA.reportPublic FDA data

Alcohol Based Hand Sanitizer

Product NDC
78539-001
11-digit product format
785390001
Labeler code
78539
Product ID
78539-001_82b5e971-d089-474d-8ed5-3992e2821c1d
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Seattle Sanitizer LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
85 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78539-001-022022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-042022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-082022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-162022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-322022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER
78539-001-642022-01-28C16284748780-1d6a99b39-c66f-a426-e053-dadaa90af4c2SEATTLE SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78539-001-02Alcohol Based Hand Sanitizer59.14 mL in 1 BOTTLESOLUTION59.141
78539-001-04Alcohol Based Hand Sanitizer118.29 mL in 1 BOTTLESOLUTION118.291
78539-001-08Alcohol Based Hand Sanitizer236.5 mL in 1 BOTTLESOLUTION236.51
78539-001-16Alcohol Based Hand Sanitizer473.17 mL in 1 BOTTLESOLUTION473.171
78539-001-32Alcohol Based Hand Sanitizer1890 mL in 1 BOTTLESOLUTION18901
78539-001-64Alcohol Based Hand Sanitizer3780 mL in 1 BOTTLESOLUTION37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78539-001ALCOHOL BASED HAND SANITIZER (ETHYL ALCOHOL) SOLUTION [SEATTLE SANITIZER LLC]1Legacy NDC, 6 package rows20200729_02b88d6c-1c64-4bb0-be81-012ce07f23f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250174ethanol 85 % Topical SolutionPSN02b88d6c-1c64-4bb0-be81-012ce07f23f11
1250174ethanol 0.85 ML/ML Topical SolutionSCD02b88d6c-1c64-4bb0-be81-012ce07f23f11
1250174ethanol 85 % Topical SolutionSY02b88d6c-1c64-4bb0-be81-012ce07f23f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78539-001-027853900010259.14 mL in 1 BOTTLE (78539-001-02) 59.14 ml2020-03-300000-00-00NoNoCurrent
78539-001-0478539000104118.29 mL in 1 BOTTLE (78539-001-04) 118.29 ml2020-03-300000-00-00NoNoCurrent
78539-001-0878539000108236.5 mL in 1 BOTTLE (78539-001-08) 236.5 ml2020-03-300000-00-00NoNoCurrent
78539-001-1678539000116473.17 mL in 1 BOTTLE (78539-001-16) 473.17 ml2020-03-300000-00-00NoNoCurrent
78539-001-32785390001321890 mL in 1 BOTTLE (78539-001-32) 1890 ml2020-03-300000-00-00NoNoCurrent
78539-001-64785390001643780 mL in 1 BOTTLE (78539-001-64) 3780 ml2020-03-300000-00-00NoNoCurrent