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 53 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORANGE HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.a9c1e4f6-e354-4624-a902-8c9154ea47232025-11-25WarningsExact identifier
application number: M003
COCONUT HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.40d7fb84-4b39-440d-a590-8aaf8ec312d72025-11-25WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESGuangzhou Baihua Co., Ltd4453997f-b885-ad2d-e063-6294a90a2c8e2025-11-24WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEVALU MERCHANDISERS, COc79540fe-b972-41a4-a215-e21e30b903d12025-11-24WarningsExact identifier
application number: M003
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
application number: M003
FloraMedis Hand SanitizerHAND SANITIZERSichuan Pengtai Qifan Technology Co., Ltd4415ca9f-10b1-88f7-e063-6294a90a2e092025-11-21WarningsExact identifier
application number: M003
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
application number: M003
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
application number: M003
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
application number: M003
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
application number: M003
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact identifier
application number: M003
Hydrogen Peroxide1169 HYDROGEN PEROXIDE SPRAYDynarex Corporation11854afb-db97-5a43-e063-6394a90aa39c2025-11-19WarningsExact identifier
application number: M003
Sani-SpritzALCOHOLABC Compounding Co., Inc.ac88c676-c396-4fb8-9e5c-77c726ed69d82025-11-19WarningsExact identifier
application number: M003
Osceola Supply Inc 6176CHLOROXYLENOLOSCEOLA SUPPLY, INC.a7dcc6b1-655d-41b3-ab97-913bc4aae01f2025-11-19WarningsExact identifier
application number: M003
AMERISILKBZKSHIELD LINE LLC43f9775c-0448-243e-e063-6294a90a9e222025-11-19WarningsExact identifier
application number: M003
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body WashCHLOROXYLENOLCarpet Rentals, Inc.a95b4d71-119e-4c3b-a280-09bd4533252b2025-11-18WarningsExact identifier
application number: M003
PetroleumWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)684ac03a-f9b1-412d-8ce5-819ca132dc342025-11-17WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD435fd382-d2f5-b07f-e063-6294a90a7d8a2025-11-14WarningsExact identifier
application number: M003
Alcohol Prep PadsISOPROPYL ALCOHOLShandong Lianfa Medical Plastic Products CO.,LTD43401653-b260-e86d-e063-6294a90abb3f2025-11-13WarningsExact 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