Pristine Clean Hand Sanitizer- Medical Grade

Product NDC
78288-201
11-digit product format
782880201
Labeler code
78288
Product ID
78288-201_9460793d-4a22-4600-8e1e-b0bf650ab247
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
High Mark Distillery, Inc. DBA: High Mark Barrel House, Inc.
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-21
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
80 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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78288-201-03Pristine Clean Hand Sanitizer- Medical Grade88.7 mL in 1 BOTTLELIQUID88.71
78288-201-08Pristine Clean Hand Sanitizer- Medical Grade236.59 mL in 1 BOTTLELIQUID236.591
78288-201-12Pristine Clean Hand Sanitizer- Medical Grade360 mL in 1 BOTTLELIQUID3601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78288-201PRISTINE CLEAN HAND SANITIZER- MEDICAL GRADE (ETHYL ALCOHOL) LIQUID [HIGH MARK DISTILLERY, INC. DBA: HIGH MARK BARREL HOUSE, INC.]1Legacy NDC, 3 package rows20200630_7020bba5-bb40-408f-91e6-52afb2f9fddf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041498ethanol 80 % Topical GelPSN7020bba5-bb40-408f-91e6-52afb2f9fddf1
1041498ethanol 0.8 ML/ML Topical GelSCD7020bba5-bb40-408f-91e6-52afb2f9fddf1
1041498ethanol 80 % Topical GelSY7020bba5-bb40-408f-91e6-52afb2f9fddf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78288-201-037828802010388.7 mL in 1 BOTTLE (78288-201-03) 88.7 ml2020-03-210000-00-00NoNoCurrent
78288-201-0878288020108236.59 mL in 1 BOTTLE (78288-201-08) 236.59 ml2020-03-210000-00-00NoNoCurrent
78288-201-1278288020112360 mL in 1 BOTTLE (78288-201-12) 360 ml2020-03-210000-00-00NoNoCurrent