FDA.reportPublic FDA data

Zytec Hand Sanitizer Wipes

Product NDC
50021-014
11-digit product format
500210014
Labeler code
50021
Product ID
50021-014_20af5fcb-c111-928a-e063-6294a90af852
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
CLOTH
Route
TOPICAL
Labeler
Empack Spraytech Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-27
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
Zytec Hand Sanitizer Wipes
Brand name suffix
80% w/w Alcohol
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
2361646Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab86fd0c-40cd-0bb6-e053-2a95a90a76e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50021-014-05Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-05Zytec Hand Sanitizer Wipes80% w/w Alcohol35 in 1 CANISTERCLOTH355
50021-014-06Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-06Zytec Hand Sanitizer Wipes80% w/w Alcohol80 in 1 CANISTERCLOTH805
50021-014-07Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-07Zytec Hand Sanitizer Wipes80% w/w Alcohol100 in 1 CANISTERCLOTH1005
50021-014-08Zytec Hand Sanitizer Wipes80% w/w Alcohol800 in 1 PAILCLOTH8005
50021-014-08Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-09Zytec Hand Sanitizer Wipes80% w/w Alcohol55 in 1 CANISTERCLOTH555
50021-014-09Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55
50021-014-10Zytec Hand Sanitizer Wipes80% w/w Alcohol180 in 1 CANISTERCLOTH1805
50021-014-10Zytec Hand Sanitizer Wipes80% w/w Alcohol5 g in 1 PATCHCLOTH55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50021-014ZYTEC HAND SANITIZER WIPES 80% W/W ALCOHOL (ALCOHOL) CLOTH [EMPACK SPRAYTECH INC.]5Current NDC, Legacy NDC, 12 package rows20241215_ab86fd0c-40cd-0bb6-e053-2a95a90a76e2.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 112 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2361646ethanol 80 % Medicated PadPSNab86fd0c-40cd-0bb6-e053-2a95a90a76e25
2361646ethanol 0.8 ML/ML Medicated PadSCDab86fd0c-40cd-0bb6-e053-2a95a90a76e25
2361646ethanol 80 % Medicated WipesSYab86fd0c-40cd-0bb6-e053-2a95a90a76e25
2361646ethyl alcohol 80 % Topical ClothSYab86fd0c-40cd-0bb6-e053-2a95a90a76e25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50021-014-055002100140535 PATCH in 1 CANISTER (50021-014-05) / 5 g in 1 PATCH35 patch2020-08-100000-00-00NoNoCurrent
50021-014-065002100140680 PATCH in 1 CANISTER (50021-014-06) / 5 g in 1 PATCH80 patch2020-08-100000-00-00NoNoCurrent
50021-014-0750021001407100 PATCH in 1 CANISTER (50021-014-07) / 5 g in 1 PATCH100 patch2020-08-100000-00-00NoNoCurrent
50021-014-0850021001408800 PATCH in 1 PAIL (50021-014-08) / 5 g in 1 PATCH800 patch2020-08-100000-00-00NoNoCurrent
50021-014-095002100140955 PATCH in 1 CANISTER (50021-014-09) / 5 g in 1 PATCH55 patch2021-09-130000-00-00NoNoCurrent
50021-014-1050021001410180 PATCH in 1 CANISTER (50021-014-10) / 5 g in 1 PATCH180 patch2021-09-130000-00-00NoNoCurrent