FDA.reportPublic FDA data

Instant Antiseptic Hand Sanitizer

Product NDC
63998-364
11-digit product format
639980364
Labeler code
63998
Product ID
63998-364_27c4d9c7-c2e6-27c3-e063-6394a90ab384
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
United Laboratories Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
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 Antiseptic Hand Sanitizer
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
f91a5ac5-0f78-4cf5-be57-6562714791cdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63998-364-01Instant Antiseptic Hand Sanitizer750 mL in 1 BOTTLESOLUTION7502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63998-364INSTANT ANTISEPTIC HAND SANITIZER (ALCOHOL) SOLUTION [UNITED LABORATORIES INC.]2Current NDC, Legacy NDC, 1 package rows20241127_f91a5ac5-0f78-4cf5-be57-6562714791cd.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
Instant Antiseptic Hand SanitizerALCOHOLUnited Laboratories Inc.f91a5ac5-0f78-4cf5-be57-6562714791cd2024-11-25WarningsExact identifier
ndc (product): 63998-364

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSNf91a5ac5-0f78-4cf5-be57-6562714791cd2
582753ethanol 0.7 ML/ML Topical SolutionSCDf91a5ac5-0f78-4cf5-be57-6562714791cd2
582753ethanol 70 % Topical SolutionSYf91a5ac5-0f78-4cf5-be57-6562714791cd2
582753ethyl alcohol 70 % Topical SolutionSYf91a5ac5-0f78-4cf5-be57-6562714791cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63998-364-0163998036401750 mL in 1 BOTTLE (63998-364-01) 750 ml2019-01-010000-00-00NoNoCurrent