FDA.reportPublic FDA data

NDC 80228-2001-01 - Hand Sanitizer

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80228-2001
Requested NDC
80228-2001-01
Package NDCs from labels
80228-2001-1, 80228-2001-01
Manufacturer
Universal Synergetics, Inc
Effective date
2025-02-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hand Sanitizer - Universal Synergetics, IncUniversal Synergetics, Inc2025-02-24HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80228-2001-12023-03-03C16284748780-1f386c64a-1af6-0266-e053-dadaa90a7c1aUniversal Synergetics Hand Sanitizer Gel, 1.2mL (.04 fl oz)
80228-2001-12023-01-30C16284748780-1f386c64a-1af6-0266-e053-dadaa90a7c1aUniversal Synergetics Hand Sanitizer Gel, 1.2mL (.04 fl oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80228-2001-1Hand Sanitizer1.2 mL in 1 POUCHGEL1.24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80228-2001HAND SANITIZER (ALCOHOL) GEL [UNIVERSAL SYNERGETICS, INC]4Current NDC, Legacy NDC, 1 package rows20250226_0dd6884c-935f-4523-b19a-201b7a8666fc.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 167 of 236 · 4,701 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECMC Group Inc.e5cb395f-5037-4b0e-9c9d-2d78b5b01b252025-01-13WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLCMC Group Inc.6f4a4538-7522-4bcf-b3cf-8dea60438a4d2025-01-13WarningsExact identifier
application number: M003
unii: ND2M416302
Refill 6ALCOHOL, WATERCMC Group, Inc.7849ae59-5484-4b86-a0b9-ec9b93d9afe02025-01-13WarningsExact identifier
application number: M003
SaniiSwabETHYL ALCOHOLPOLLEY MED LLC2ad08239-18ea-9ec9-e063-6394a90a3a542025-01-10WarningsExact identifier
unii: 3K9958V90M
EVR Povidone lodine WipePOVIDONE LODINEChangzhou Maokang Medical Products Co., Ltd.2b57e301-74e0-e1db-e063-6294a90a6c182025-01-10WarningsExact identifier
application number: M003
EVR Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.2b584d09-916c-00f8-e063-6294a90adbcf2025-01-10WarningsExact identifier
application number: M003
unii: ND2M416302
Medzah Ditek Alcohol Prep PadsISOPROPYL ALCOHOLMedzah Industries4e6e5b6b-147c-4e7c-9b8c-6a3116c4bdac2025-01-10WarningsExact identifier
application number: M003
unii: ND2M416302
AntibacterialALCOHOLHenry Schein Inc.87446203-1365-49b6-9346-62fb8ec783112025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.e80feb63-2c51-4164-806d-778e39e620e82025-01-10WarningsExact identifier
unii: 3K9958V90M
Instant Hand SanitizerALCOHOLHenry Schein, Inc.3b075cdc-509d-4259-99a2-0e219998949d2025-01-10WarningsExact identifier
unii: 3K9958V90M
Hand Guard Foaming Alcohol Instant Hand SanitizerALCOHOLWechem, Inc.2b60cd24-f0a9-5c54-e063-6394a90ab3502025-01-10WarningsExact identifier
unii: 3K9958V90M
Alcohol Prep Pad-LargeISOPROPYL ALCOHOLGlobal Biomedical Technologies, LLC93d00515-e93f-48a3-b66b-7d933e734e542025-01-10WarningsExact identifier
application number: M003
unii: ND2M416302
ChemStation E3 Hand SanitizerETHANOLChemstation4a37ef06-b74b-1ed1-e054-00144ff8d46c2025-01-09WarningsExact identifier
unii: 3K9958V90M
DERMADIVE ULTRACARE - TETRAIDBENZALKONIUM CHLORIDEReleaf Technologies LLC025c0b33-73ca-334b-e063-6394a90ad6682025-01-09WarningsExact identifier
application number: M003
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr Tichenors First Aid AntisepticALCOHOLDr. G. H. Tichenor's Antiseptic Company9947855d-b8e0-4c22-a627-16b526242e392025-01-09WarningsExact identifier
rxcui: 581662
unii: 3K9958V90M
Drs. pharmacy triple antibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLCbb730976-0045-c0ae-e053-2a95a90af34e2025-01-09WarningsExact identifier
application number: M003
Drs. Antibiotic BacitracinBACITRACINOL PHARMA TECH, LLCc26493c4-0bc1-5fdc-e053-2995a90a81e62025-01-09WarningsExact identifier
application number: M003

Reported adverse events (FAERS/openFDA)#

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