FDA.reportPublic FDA data

Extra Stength Hand Sanitizer

Product NDC
50021-008
11-digit product format
500210008
Labeler code
50021
Product ID
50021-008_20af5ae7-2a91-ff8d-e063-6394a90ad503
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol 80%w/w
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Empack Spraytech Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-08
Substance
ALCOHOL
Active strength
80 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Stength Hand Sanitizer
Brand name suffix
Zytec Germ Buster
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL80 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1241663Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da854195-3a50-4fae-a5ea-183bf524c973Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-008-01Extra Stength Hand SanitizerZytec Germ Buster51 g in 1 CANAEROSOL, SPRAY516
50021-008-02Extra Stength Hand SanitizerZytec Germ Buster100 g in 1 CANAEROSOL, SPRAY1006
50021-008-03Extra Stength Hand SanitizerZytec Germ Buster125 g in 1 CANAEROSOL, SPRAY1256
50021-008-04Extra Stength Hand SanitizerZytec Germ Buster200 g in 1 CANAEROSOL, SPRAY2006
50021-008-05Extra Stength Hand SanitizerZytec Germ Buster253 g in 1 CANAEROSOL, SPRAY2536
50021-008-06Extra Stength Hand SanitizerZytec Germ Buster400 g in 1 CANAEROSOL, SPRAY4006
50021-008-07Extra Stength Hand SanitizerZytec Germ Buster70 g in 1 CANAEROSOL, SPRAY706
50021-008-08Extra Stength Hand SanitizerZytec Germ Buster352 g in 1 CANAEROSOL, SPRAY3526
50021-008-09Extra Stength Hand SanitizerZytec Germ Buster176 g in 1 CANAEROSOL, SPRAY1766

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-008EXTRA STENGTH HAND SANITIZER ZYTEC GERM BUSTER (ALCOHOL 80%W/W) AEROSOL, SPRAY [EMPACK SPRAYTECH INC.]6Current NDC, Legacy NDC, 9 package rows20241215_da854195-3a50-4fae-a5ea-183bf524c973.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 31 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RubbingETHYL ALCOHOLUnited Natural Foods, Inc. dba UNFIcd03611f-879a-4888-8d45-f8bdfd82529c2026-02-26Warnings, Adverse reactionsExact identifier
application number: M003
Lightning X POVIDONE IODINE WIPEPOVIDONE IODINE WIPEChangzhou Maokang Medical Products Co., Ltd.04be4c2f-742b-7058-e063-6394a90a460d2026-02-25WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL RUBBING ALCOHOLBetter Living Brands, LLC4817df03-05a2-4e85-bec2-a06f9d57d0b82026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC4031ea5d-cba4-44f5-9a81-0cab2367d97e2026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEBetter Living Brands, LLC1b2decdf-58be-4ab9-a481-6c78bd91faf02026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLBetter Living Brands, LLC6391432a-a5b8-4528-88a6-862bc2062f682026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEFamily Dollar Stores, Inc58157bc5-54ea-49f8-9f17-f0eeb57323952026-02-24Warnings, Adverse reactionsExact identifier
application number: M003
Sunvine 70 Isopropyl Alcohol First Aid AntisepticISOPROPYL ALCOHOLMac Innovations, LLC8435ef45-5d2c-4bbb-b9e0-0b00c1ec8c762026-02-24WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLALCOVE BRANDS4bad1fee-b4fe-c518-e063-6294a90a03182026-02-24WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEBetter Living Brands, LLC3ce6e6af-b513-ed9f-e063-6394a90a4ce72026-02-23Warnings, Adverse reactionsExact identifier
application number: M003
Scent Theory Hand Sanitizers Cherry Pop, Ocean Splash, Juicy PearALCOHOLScent Theory Products LLC4b865d82-71c3-1023-e063-6294a90ac7742026-02-23WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%4 Visions LLC4b87254a-8dc5-3873-e063-6394a90a3f3b2026-02-23WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOL4 Visions LLC4b87d4cc-163e-1432-e063-6294a90af4832026-02-23WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC4b88008f-fe78-4b7e-e063-6294a90ab9ae2026-02-23WarningsExact identifier
application number: M003
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESave-A-Lot Food Stores Ltde279b23d-6779-4f04-a93c-1c2a495596392026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMeijer, Inc.4989f1cd-4555-405a-a5f8-8714d472983c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1241663ethanol 80 % Topical SprayPSNda854195-3a50-4fae-a5ea-183bf524c9736
1241663ethanol 0.8 ML/ML Topical SpraySCDda854195-3a50-4fae-a5ea-183bf524c9736
1241663ethanol 80 % Topical SpraySYda854195-3a50-4fae-a5ea-183bf524c9736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50021-008-015002100080151 g in 1 CAN (50021-008-01) 51 g2020-04-080000-00-00NoNoCurrent
50021-008-0250021000802100 g in 1 CAN (50021-008-02) 100 g2020-04-080000-00-00NoNoCurrent
50021-008-0350021000803125 g in 1 CAN (50021-008-03) 125 g2020-04-080000-00-00NoNoCurrent
50021-008-0450021000804200 g in 1 CAN (50021-008-04) 200 g2020-04-080000-00-00NoNoCurrent
50021-008-0550021000805253 g in 1 CAN (50021-008-05) 253 g2020-04-080000-00-00NoNoCurrent
50021-008-0650021000806400 g in 1 CAN (50021-008-06) 400 g2020-04-080000-00-00NoNoCurrent
50021-008-075002100080770 g in 1 CAN (50021-008-07) 70 g2020-04-150000-00-00NoNoCurrent
50021-008-0850021000808352 g in 1 CAN (50021-008-08) 352 g2020-04-150000-00-00NoNoCurrent
50021-008-0950021000809176 g in 1 CAN (50021-008-09) 176 g2020-04-150000-00-00NoNoCurrent