FDA.reportPublic FDA data

Pharma Cleanse HAND SANITIZER

Product NDC
78528-001
11-digit product format
785280001
Labeler code
78528
Product ID
78528-001_d0532f63-1c75-6560-e053-2a95a90a5e16
Type
HUMAN OTC DRUG
Nonproprietary name
HAND SANITIZER
Dosage form
GEL
Route
TOPICAL
Labeler
Ballistic LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-18
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 mL/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78528-001-012023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-022023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-032023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-042023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-052023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER
78528-001-062023-01-30C16284748780-1f386c649-a729-0266-e053-dadaa90a7c1aPharma Cleanse HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78528-001-01Pharma Cleanse HAND SANITIZER40 mL in 1 BOTTLEGEL403
78528-001-02Pharma Cleanse HAND SANITIZER60 mL in 1 BOTTLEGEL603
78528-001-03Pharma Cleanse HAND SANITIZER500 mL in 1 BOTTLE, PUMPGEL5003
78528-001-04Pharma Cleanse HAND SANITIZER1000 mL in 1 BOTTLE, PUMPGEL10003
78528-001-05Pharma Cleanse HAND SANITIZER2000 mL in 1 BOTTLEGEL20003
78528-001-06Pharma Cleanse HAND SANITIZER3785 mL in 1 BOTTLEGEL37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78528-001PHARMA CLEANSE HAND SANITIZER (HAND SANITIZER) GEL [BALLISTIC LLC]3Legacy NDC, 6 package rows20211110_a7101d55-615a-5cd1-e053-2a95a90a9095.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa7101d55-615a-5cd1-e053-2a95a90a90953
1305100ethanol 0.75 ML/ML Topical GelSCDa7101d55-615a-5cd1-e053-2a95a90a90953
1305100ethanol 75 % Topical GelSYa7101d55-615a-5cd1-e053-2a95a90a90953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78528-001-017852800010140 mL in 1 BOTTLE (78528-001-01) 40 ml2020-05-180000-00-00NoNoCurrent
78528-001-027852800010260 mL in 1 BOTTLE (78528-001-02) 60 ml2020-05-180000-00-00NoNoCurrent
78528-001-0378528000103500 mL in 1 BOTTLE, PUMP (78528-001-03) 500 ml2020-05-180000-00-00NoNoCurrent
78528-001-04785280001041000 mL in 1 BOTTLE, PUMP (78528-001-04) 1000 ml2020-05-180000-00-00NoNoCurrent
78528-001-05785280001052000 mL in 1 BOTTLE (78528-001-05) 2000 ml2020-05-180000-00-00NoNoCurrent
78528-001-06785280001063785 mL in 1 BOTTLE (78528-001-06) 3785 ml2020-05-180000-00-00NoNoCurrent