FDA.reportPublic FDA data

NO-WASH ANTIBACTERIAL

Product NDC
77331-001
11-digit product format
773310001
Labeler code
77331
Product ID
77331-001_63484d1d-53c2-46c4-b9fe-9dd23ccdbdb5
Type
HUMAN OTC DRUG
Nonproprietary name
ETHANOL
Dosage form
GEL
Route
TOPICAL
Labeler
MAJESTIC GROUP LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77331-001-012022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-022022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-032022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-042022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-052022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-062022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-072022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-082022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-092022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-102022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-112022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-122022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-132022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL
77331-001-142022-01-28C16284748780-1d6a99b39-8c04-a426-e053-dadaa90af4c2NO-WASH ANTIBACTERIAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77331-001-01NO-WASH ANTIBACTERIAL500 mL in 1 BOTTLEGEL5002
77331-001-02NO-WASH ANTIBACTERIAL20 mL in 1 BOTTLEGEL202
77331-001-03NO-WASH ANTIBACTERIAL30 mL in 1 BOTTLEGEL302
77331-001-04NO-WASH ANTIBACTERIAL40 mL in 1 BOTTLEGEL402
77331-001-05NO-WASH ANTIBACTERIAL50 mL in 1 BOTTLEGEL502
77331-001-06NO-WASH ANTIBACTERIAL60 mL in 1 BOTTLEGEL602
77331-001-07NO-WASH ANTIBACTERIAL80 mL in 1 BOTTLEGEL802
77331-001-08NO-WASH ANTIBACTERIAL100 mL in 1 BOTTLEGEL1002
77331-001-09NO-WASH ANTIBACTERIAL120 mL in 1 BOTTLEGEL1202
77331-001-10NO-WASH ANTIBACTERIAL250 mL in 1 BOTTLEGEL2502
77331-001-11NO-WASH ANTIBACTERIAL300 mL in 1 BOTTLEGEL3002
77331-001-12NO-WASH ANTIBACTERIAL1000 mL in 1 BOTTLEGEL10002
77331-001-13NO-WASH ANTIBACTERIAL2000 mL in 1 BOTTLEGEL20002
77331-001-14NO-WASH ANTIBACTERIAL5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77331-001NO-WASH ANTIBACTERIAL (ETHANOL) GEL [MAJESTIC GROUP LLC]2Legacy NDC, 14 package rows20200513_c47ddba9-9356-4225-a28b-69c5095006b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNc47ddba9-9356-4225-a28b-69c5095006b42
1305100ethanol 0.75 ML/ML Topical GelSCDc47ddba9-9356-4225-a28b-69c5095006b42
1305100ethanol 75 % Topical GelSYc47ddba9-9356-4225-a28b-69c5095006b42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
77331-001-0177331000101500 mL in 1 BOTTLE (77331-001-01) 500 ml2020-05-060000-00-00NoNoCurrent
77331-001-027733100010220 mL in 1 BOTTLE (77331-001-02) 20 ml2020-05-060000-00-00NoNoCurrent
77331-001-037733100010330 mL in 1 BOTTLE (77331-001-03) 30 ml2020-05-060000-00-00NoNoCurrent
77331-001-047733100010440 mL in 1 BOTTLE (77331-001-04) 40 ml2020-05-060000-00-00NoNoCurrent
77331-001-057733100010550 mL in 1 BOTTLE (77331-001-05) 50 ml2020-05-060000-00-00NoNoCurrent
77331-001-067733100010660 mL in 1 BOTTLE (77331-001-06) 60 ml2020-05-060000-00-00NoNoCurrent
77331-001-077733100010780 mL in 1 BOTTLE (77331-001-07) 80 ml2020-05-060000-00-00NoNoCurrent
77331-001-0877331000108100 mL in 1 BOTTLE (77331-001-08) 100 ml2020-05-060000-00-00NoNoCurrent
77331-001-0977331000109120 mL in 1 BOTTLE (77331-001-09) 120 ml2020-05-060000-00-00NoNoCurrent
77331-001-1077331000110250 mL in 1 BOTTLE (77331-001-10) 250 ml2020-05-060000-00-00NoNoCurrent
77331-001-1177331000111300 mL in 1 BOTTLE (77331-001-11) 300 ml2020-05-060000-00-00NoNoCurrent
77331-001-12773310001121000 mL in 1 BOTTLE (77331-001-12) 1000 ml2020-05-060000-00-00NoNoCurrent
77331-001-13773310001132000 mL in 1 BOTTLE (77331-001-13) 2000 ml2020-05-060000-00-00NoNoCurrent
77331-001-14773310001145000 mL in 1 BOTTLE (77331-001-14) 5000 ml2020-05-060000-00-00NoNoCurrent