FDA.reportPublic FDA data

CleanGenic 8 OZ HAND SANITIZER

Product NDC
81385-003
11-digit product format
813850003
Labeler code
81385
Product ID
81385-003_08c00977-1db2-6d24-e063-6294a90a9cfe
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
CleanGenic, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-10
Substance
ALCOHOL
Active strength
62 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
CleanGenic 8 OZ HAND SANITIZER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 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
616763Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9828dd7-63a1-0bf4-e053-2a95a90a4569Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81385-003-08CleanGenic 8 OZ HAND SANITIZER24 in 1 BOXLIQUID243
81385-003-08CleanGenic 8 OZ HAND SANITIZER237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81385-003CLEANGENIC 8 OZ HAND SANITIZER (ALCOHOL) LIQUID [CLEANGENIC, LLC]3Current NDC, Legacy NDC, 2 package rows20231030_b9828dd7-63a1-0bf4-e053-2a95a90a4569.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
CleanGenic 8 OZ HAND SANITIZERALCOHOLCleanGenic, LLCb9828dd7-63a1-0bf4-e053-2a95a90a45692023-10-28WarningsExact identifier
ndc (product): 81385-003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616763ethanol 62 % Topical FoamPSNb9828dd7-63a1-0bf4-e053-2a95a90a45693
616763ethanol 0.62 ML/ML Topical FoamSCDb9828dd7-63a1-0bf4-e053-2a95a90a45693
616763ethanol 62 % Topical FoamSYb9828dd7-63a1-0bf4-e053-2a95a90a45693

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81385-003-088138500030824 BOTTLE in 1 BOX (81385-003-08) / 237 mL in 1 BOTTLE24 bottle2020-06-100000-00-00NoNoCurrent