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 42 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine Prep PadPOVIDONE-IODINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.6d472aef-0d95-4c21-a373-bd16bc7b63ed2026-01-12WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.3cce065a-0254-43ad-a96f-aae6979997be2026-01-12WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.b58145c6-0f6c-5a47-e053-2995a90a5d7f2026-01-09WarningsExact identifier
application number: M003
Quality Choice Hydrogen Peroxide WipesHYDROGEN PEROXIDEChain Drug Marketing Association, Inc.b5815ca2-edaa-bc8c-e053-2a95a90a3df22026-01-09WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLJC SALES1f3466d2-6a2e-f871-e063-6394a90af0852026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products1e2cb45c-7e70-01dd-e063-6294a90aa16b2026-01-09WarningsExact identifier
application number: M003
NOxyDERMBENZALKONIUM CHLORIDENOxy Health Products063a1e99-dda6-9cb9-e063-6294a90aa1b32026-01-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLEpic Medical Supply Corp.04ac8597-00fa-458f-a929-ada5042a8c382026-01-09WarningsExact identifier
application number: M003
Instant Hand Sanitizeing WipeALCOHOLSHANDONG HENGFA HYGIENIC PRODUCTS CO., LTD.bd17c0c7-d824-6b03-e053-2995a90afe152026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 3.3% PCMXCHLOROXYLENOLXinxiang Xinda Technology Co.,Ltd125b3c3b-0a3a-9fd3-e063-6394a90a135a2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd125a49c3-15c0-fbad-e063-6394a90a5d2e2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail Cleaner 4% CHGCHLORHEXIDINE GLUCONATEXinxiang Xinda Technology Co.,Ltd125ac9df-03db-83e9-e063-6394a90afeab2026-01-08WarningsExact identifier
application number: M003
Surgical Scrub Brush/Sponge With Nail CleanerPOVIDONE IODINEXinxiang Xinda Technology Co.,Ltd12585502-c043-6ffb-e063-6394a90a66022026-01-08WarningsExact identifier
application number: M003
Thompson AlcoholISOPROPYL ALCOHOLThompsonf539db3b-f309-6a60-e053-2a95a90a5a9b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d35899-8b70-14f0-e053-2995a90a5ce82026-01-08WarningsExact identifier
application number: M003
Germ AwayANTI-MICROBIAL WIPEUnico International Trading Corpa6b4eec4-0b12-3a00-e053-2a95a90a78352026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d0ce42-9076-143c-e053-2995a90aeeb62026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation261c7b8f-4adc-72ec-e063-6394a90a92112026-01-08WarningsExact identifier
application number: M003
WipexANTIBACTERIAL WIPEUnico International Trading Corporation144453a2-8335-77be-e063-6394a90ab6762026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact 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