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 58 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol Swab SticksISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC91a9d6f7-d16c-46bf-8389-a6771e3ebfba2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC9d79480c-ceef-49f7-a830-171c2a2629392025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLCardinal Health 200, Inc.a1bccbf5-9cee-46c0-890c-02eb3577c1932025-10-23WarningsExact identifier
application number: M003
Alcohol WipesISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC04c2ac54-1f44-a5d2-e063-6394a90a99cc2025-10-23WarningsExact identifier
application number: M003
Alcohol PrepISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLC2a160c89-c438-455d-910d-ac359d46786f2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLCe917b371-3ca9-94f0-e053-2a95a90af8ad2025-10-23WarningsExact identifier
application number: M003
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
application number: M003
CareTouch Alcohol Prep PadISOPROPYL ALCOHOLFuture Diagnostics Llc91cfd7bf-9f42-49d5-b20d-281779d5272d2025-10-23WarningsExact identifier
application number: M003
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEPHOENIX HEALTHCARE SOLUTIONS, LLCdab5e937-bd92-467b-b1ac-a2428a814bc32025-10-23WarningsExact identifier
application number: M003
Alcohol WipeISOPROPYL ALCOHOLWalmart Inc.067c3983-d450-e86b-e063-6294a90ab7582025-10-23WarningsExact identifier
application number: M003
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC24337cc6-98fe-ca0b-e063-6394a90a8b7b2025-10-23WarningsExact identifier
application number: M003
Sting and BiteBENZOCAINEPHOENIX HEALTHCARE SOLUTIONS, LLC82791832-1357-48ca-91d4-1328997012612025-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCa225426a-c4d5-459c-bc11-2b521e08e5102025-10-23WarningsExact identifier
application number: M003
Alcohol SwabsISOPROPYL ALCOHOLPhoenix Healthcare Solutions LLC1516d90b-4879-eb2f-e063-6294a90aa9142025-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
application number: M003
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
application number: M003
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
application number: M003
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact 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