FDA.reportPublic FDA data

INSTANT HAND SANITIZER Classic

Product NDC
52000-434
11-digit product format
520000434
Labeler code
52000
Product ID
52000-434_5855b96f-1293-4a23-9b39-5161290d63e9
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-20
Substance
ALCOHOL
Active strength
70 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
INSTANT HAND SANITIZER Classic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 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
582753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65faf3d6-4e1c-4092-ac77-f6d77bf49cd6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-434-01INSTANT HAND SANITIZER Classic1000 mL in 1 BOTTLE, PUMPLIQUID10001
52000-434-08INSTANT HAND SANITIZER Classic236 mL in 1 BOTTLE, PUMPLIQUID2361

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
INSTANT HAND SANITIZER ClassicETHYL ALCOHOLUniversal Distribution Center LLC65faf3d6-4e1c-4092-ac77-f6d77bf49cd62025-11-20WarningsExact identifier
ndc (product): 52000-434

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN65faf3d6-4e1c-4092-ac77-f6d77bf49cd61
582753ethanol 0.7 ML/ML Topical SolutionSCD65faf3d6-4e1c-4092-ac77-f6d77bf49cd61
582753ethanol 70 % Topical SolutionSY65faf3d6-4e1c-4092-ac77-f6d77bf49cd61
582753ethyl alcohol 70 % Topical SolutionSY65faf3d6-4e1c-4092-ac77-f6d77bf49cd61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-434-01520000434011000 mL in 1 BOTTLE, PUMP (52000-434-01) 1000 ml2025-11-20NoNoCurrent
52000-434-0852000043408236 mL in 1 BOTTLE, PUMP (52000-434-08) 236 ml2025-11-20NoNoCurrent