Serene Clean and Pure Hand Sanitizer Gel

Product NDC
78643-300
11-digit product format
786430300
Labeler code
78643
Product ID
78643-300_b82d4cdc-3466-6221-e053-2a95a90ae868
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
Serene Clean & Pure LLC
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-05
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
65 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
78643-300-012023-01-30C16284748780-1f386c649-ee1b-0266-e053-dadaa90a7c1aSerene Clean & Pure Ethanol Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78643-300-01Serene Clean and Pure Hand Sanitizer Gel3785.41 mL in 1 BOTTLE, PLASTICGEL3785.411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78643-300SERENE CLEAN AND PURE HAND SANITIZER GEL (ETHANOL) GEL [SERENE CLEAN & PURE LLC]1Legacy NDC, 1 package rows20210106_b82d40b0-3a6b-4227-e053-2995a90adfac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSNb82d40b0-3a6b-4227-e053-2995a90adfac1
902574ethanol 0.65 ML/ML Topical GelSCDb82d40b0-3a6b-4227-e053-2995a90adfac1
902574ethyl alcohol 65 % Topical GelSYb82d40b0-3a6b-4227-e053-2995a90adfac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78643-300-01786430300013785.41 mL in 1 BOTTLE, PLASTIC (78643-300-01) 3785.41 ml2020-11-050000-00-00NoNoCurrent