FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
80228-2001
11-digit product format
802282001
Labeler code
80228
Product ID
80228-2001_2eea5c8b-01b7-4fd2-e063-6294a90a2b46
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Synergetics, Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Marketing end
2026-11-05
Substance
ALCOHOL
Active strength
.84 mL/1.2mL
NDC exclude flag
No
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
Hand Sanitizer

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.84 mL/1.2mL

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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0dd6884c-935f-4523-b19a-201b7a8666fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

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 24 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scriptsusa Hand SanitizerALCOHOLEnergized Solution Corp4f97edd9-717a-315b-e063-6394a90aade72026-04-27WarningsExact identifier
application number: M003
Tigerherbs Natural Healing CreamBEDSORE CREAMShenzhen Yao Yu Technology Co., LTD392c3666-b86e-9266-e063-6394a90ae5022026-04-25WarningsExact identifier
application number: M003
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
application number: M003
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsExact identifier
application number: M003
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
application number: M003
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.4fcf2c05-9bd2-2813-e063-6294a90a44012026-04-19WarningsExact identifier
application number: M003
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC249e00ef-fe9d-dc07-e063-6394a90a9f4c2026-04-16WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4f9adbac-5497-e7be-e063-6294a90a75182026-04-16WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC2d940d35-6a73-e494-e063-6394a90a9d162026-04-14WarningsExact identifier
application number: M003
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalmart Inc.ebd02cd3-75cc-444b-8284-d28733a2855b2026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Hand Sanitizer Sunset GuavaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f01fc3a-5b01-4b6b-e063-6294a90aefb42026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f02adaa-1440-5778-e063-6294a90a344a2026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Watermelon WaveALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f031f62-e56c-9063-e063-6394a90af9c12026-04-09WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN0dd6884c-935f-4523-b19a-201b7a8666fc4
581662ethanol 0.7 ML/ML Topical GelSCD0dd6884c-935f-4523-b19a-201b7a8666fc4
581662ethanol 70 % Topical GelSY0dd6884c-935f-4523-b19a-201b7a8666fc4
581662ethyl alcohol 70 % Topical GelSY0dd6884c-935f-4523-b19a-201b7a8666fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80228-2001-1802282001011.2 mL in 1 POUCH (80228-2001-1) 1.2 ml2021-04-132026-11-05NoNoCurrent