FDA.reportPublic FDA data

Compass 70% Ethanol Hand Sanitizer Gel with Citrus

Product NDC
78346-008
11-digit product format
783460008
Labeler code
78346
Product ID
78346-008_e7024adf-2fbd-3e1c-e053-2a95a90af361
Type
HUMAN OTC DRUG
Nonproprietary name
70% Ethanol Hand Sanitizer
Dosage form
GEL
Route
TOPICAL
Labeler
Otto Solutions LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-09
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78346-008-012023-07-28C16284748780-10191ceaa-70b5-198a-e063-dbdaa90aec3eHand Sanitizer
78346-008-022023-07-28C16284748780-10191ceaa-70b5-198a-e063-dbdaa90aec3eHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78346-008-01Compass 70% Ethanol Hand Sanitizer Gel with Citrus3785 mL in 1 BOTTLEGEL378514
78346-008-02Compass 70% Ethanol Hand Sanitizer Gel with Citrus15142 mL in 1 CASEGEL1514214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78346-008DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH ROSE (70% ETHANOL HAND SANITIZER) GEL KIRANEX 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL COMPASS 70% ETHANOL HAND SANITIZER GEL WITH CITRUS (70% ETHANOL HAND SANITIZER) GEL COMPASS 70% ETHANOL HAND SANITIZER GEL WITH LAVENDER (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER GEL (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER (70% ETHANOL HAND SANITIZER) LIQUID DR LUCID HAND SANITIZER (65% ETHANOL) GEL DR LUCID 70% IPA SANITIZER (70% ISOPROPANOL) LIQUID DR LUCID 91% IPA SANITIZER (91% ISOPROPANOL) LIQUID SAFETY FIRST 70% ETHANOL HAND SANITIZER GEL (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER GEL WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH ROSE (70% ETHANOL HAND SANITIZER) GEL DR LUCID 70% ETHANOL HAND SANITIZER LIQUID WITH EUCALYPTUS (70% ETHANOL HAND SANITIZER) GEL [OTTO SOLUTIONS LLC]14Legacy NDC, 2 package rows20220826_a6b82bf2-2362-38f2-e053-2995a90a31ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa6b82bf2-2362-38f2-e053-2995a90a31ed14
581662ethanol 0.7 ML/ML Topical GelSCDa6b82bf2-2362-38f2-e053-2995a90a31ed14
581662ethanol 70 % Topical GelSYa6b82bf2-2362-38f2-e053-2995a90a31ed14
581662ethyl alcohol 70 % Topical GelSYa6b82bf2-2362-38f2-e053-2995a90a31ed14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78346-008-01783460008013785 mL in 1 BOTTLE (78346-008-01) 3785 ml2020-11-090000-00-00NoNoCurrent
78346-008-027834600080215142 mL in 1 CASE (78346-008-02) 15142 ml2020-11-090000-00-00NoNoCurrent