FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
50021-009
11-digit product format
500210009
Labeler code
50021
Product ID
50021-009_20af5ae7-2a82-ff8d-e063-6394a90ad503
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol 70%v/v
Dosage form
GEL
Route
TOPICAL
Labeler
Empack Spraytech Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-24
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer
Brand name suffix
Zytec Germ Buster
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui581662

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-009-01Hand SanitizerZytec Germ Buster100 mL in 1 BOTTLE, PUMPGEL1003
50021-009-02Hand SanitizerZytec Germ Buster240 mL in 1 BOTTLE, PUMPGEL2403
50021-009-03Hand SanitizerZytec Germ Buster500 mL in 1 BOTTLE, PUMPGEL5003
50021-009-04Hand SanitizerZytec Germ Buster1000 mL in 1 BOTTLE, PUMPGEL10003
50021-009-05Hand SanitizerZytec Germ Buster3785 mL in 1 PACKAGEGEL37853
50021-009-06Hand SanitizerZytec Germ Buster240 mL in 1 TUBEGEL2403
50021-009-07Hand SanitizerZytec Germ Buster60 mL in 1 TUBEGEL603
50021-009-08Hand SanitizerZytec Germ Buster120 mL in 1 TUBEGEL1203
50021-009-09Hand SanitizerZytec Germ Buster270 mL in 1 TUBEGEL2703
50021-009-10Hand SanitizerZytec Germ Buster540 mL in 1 TUBEGEL5403
50021-009-11Hand SanitizerZytec Germ Buster1030 mL in 1 TUBEGEL10303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-009HAND SANITIZER ZYTEC GERM BUSTER (ALCOHOL 70%V/V) GEL [EMPACK SPRAYTECH INC.]3Current NDC, Legacy NDC, 11 package rows20240922_f8f17337-6eac-465f-b961-3fec1c3c0f1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNf8f17337-6eac-465f-b961-3fec1c3c0f1f3
581662ethanol 0.7 ML/ML Topical GelSCDf8f17337-6eac-465f-b961-3fec1c3c0f1f3
581662ethanol 70 % Topical GelSYf8f17337-6eac-465f-b961-3fec1c3c0f1f3
581662ethyl alcohol 70 % Topical GelSYf8f17337-6eac-465f-b961-3fec1c3c0f1f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50021-009-0150021000901100 mL in 1 BOTTLE, PUMP (50021-009-01) 100 ml2020-04-240000-00-00NoNoCurrent
50021-009-0250021000902240 mL in 1 BOTTLE, PUMP (50021-009-02) 240 ml2020-04-240000-00-00NoNoCurrent
50021-009-0350021000903500 mL in 1 BOTTLE, PUMP (50021-009-03) 500 ml2020-04-240000-00-00NoNoCurrent
50021-009-04500210009041000 mL in 1 BOTTLE, PUMP (50021-009-04) 1000 ml2020-04-240000-00-00NoNoCurrent
50021-009-05500210009053785 mL in 1 PACKAGE (50021-009-05) 3785 ml2020-04-240000-00-00NoNoCurrent
50021-009-0650021000906240 mL in 1 TUBE (50021-009-06) 240 ml2020-05-190000-00-00NoNoCurrent
50021-009-075002100090760 mL in 1 TUBE (50021-009-07) 60 ml2022-07-05NoNoCurrent
50021-009-0850021000908120 mL in 1 TUBE (50021-009-08) 120 ml2022-07-05NoNoCurrent
50021-009-0950021000909270 mL in 1 TUBE (50021-009-09) 270 ml2022-07-05NoNoCurrent
50021-009-1050021000910540 mL in 1 TUBE (50021-009-10) 540 ml2022-07-05NoNoCurrent
50021-009-11500210009111030 mL in 1 TUBE (50021-009-11) 1030 ml2022-07-05NoNoCurrent