FDA.reportPublic FDA data

Iso-Quin hand sanitizer

Product NDC
82345-858
Requested package NDC
82345-858-10
11-digit product format
823450858
Labeler code
82345
Product ID
82345-858_097353b6-422b-cea1-e063-6294a90aea19
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
The Hygenic Company, LLC.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
ALCOHOL
Active strength
65 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Iso-Quin hand sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL65 mL/100mL

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
884783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1003c9f-a6f8-3de2-e053-2995a90a6e8aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-858-10Iso-Quin hand sanitizer3785 mL in 1 BOTTLELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-858ISO-QUIN HAND SANITIZER (ALCOHOL) LIQUID [THE HYGENIC COMPANY, LLC.]2Current NDC, Legacy NDC, 1 package rows20231106_d1003c9f-a6f8-3de2-e053-2995a90a6e8a.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Iso-Quin hand sanitizerALCOHOLThe Hygenic Company, LLC.d1003c9f-a6f8-3de2-e053-2995a90a6e8a2023-11-05WarningsExact identifier
ndc (package): 82345-858-10
ndc (product): 82345-858
ndc11 (package): 82345085810

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884783ethanol 65 % Topical SolutionPSNd1003c9f-a6f8-3de2-e053-2995a90a6e8a2
884783ethanol 0.65 ML/ML Topical SolutionSCDd1003c9f-a6f8-3de2-e053-2995a90a6e8a2
884783ethanol 65 % Topical SolutionSYd1003c9f-a6f8-3de2-e053-2995a90a6e8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82345-858-10823450858103785 mL in 1 BOTTLE (82345-858-10) 3785 ml2022-04-010000-00-00NoNoCurrent