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 74 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 70000bf355e30-ad2f-4f93-9d77-8efd6a908e582025-07-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 Percent WintergreenISOPROPYL ALCOHOLBest Choice (Valu Merchandisers Company)abcc7941-e521-4ad6-89df-0b965b634eb32025-07-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 700005ffa8ecf-1349-4758-8d47-e9a96d2ddaee2025-07-11WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39904847-ed55-f4a3-e063-6294a90a85a12025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.397a897a-baab-d209-e063-6294a90aac652025-07-10WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.398fd961-d5e6-9d40-e063-6294a90a5be52025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39901012-e1a1-c6e3-e063-6294a90ab41f2025-07-10WarningsExact identifier
application number: M003
AerowipeALCOHOL WIPEAero Healthcare34c93704-9f3c-6746-e054-00144ff8d46c2025-07-10WarningsExact identifier
application number: M003
Walgreens 10 Povidone-Iodine SolutionPOVIDONE-IODINEWALGREEN COMPANYa7b635d0-9109-4cd6-9b96-fba0d76464fc2025-07-10WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.502b09be-b7e6-4ad7-be17-4c8b0e93b4ab2025-07-07WarningsExact identifier
application number: M003
Signature Select isopropyl alcohol wipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.97272c57-88f0-40d9-b11f-d53cb806ee732025-07-04WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinUNIVERSAL 70% RUBBING ALCOHOL WITH WINTERGREEN AND GLYCERIN - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC390c6afd-e2c2-414c-e063-6294a90ae1192025-07-03WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENT WINTERGREENISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83f562-7ec7-72f3-e063-6294a90aba4d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 50 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4b83e678-b79f-6dd6-e063-6294a90ad09d2025-07-01WarningsExact identifier
application number: M003
RUBBING ALCOHOL 70 PERCENTISOPROPYL ALCOHOLViny Health and Beauty Products Inc4babe369-3a35-34b5-e063-6394a90a68322025-07-01WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd38c323e2-9a9a-f898-e063-6394a90aa2262025-06-30WarningsExact identifier
application number: M003
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
application number: M003
HAND SANITIZER FRESH LINENALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e492b-0690-a345-e063-6294a90aef2c2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e98dd-22ec-d4a3-e063-6394a90a80fa2025-06-29WarningsExact identifier
application number: M003
HAND SANITIZER STRAWBERRY FIZZALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e3045-14dc-ac2e-e063-6394a90a9b8a2025-06-29WarningsExact 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