FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
53942-370
Requested package NDC
53942-370-16
11-digit product format
539420370
Labeler code
53942
Product ID
53942-370_49f0a896-17c3-5259-e063-6294a90abf8a
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-22
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer
Listing expiration
2027-12-31

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
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
bfe6c08a-a584-4bfb-b28f-492333a0082aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-370-16Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL5919
53942-370-34Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL23619

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-370HAND SANITIZER (ALCOHOL) GEL [DEMOULAS SUPER MARKETS, INC]17Current NDC, Legacy NDC, 2 package rows20240820_bfe6c08a-a584-4bfb-b28f-492333a0082a.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
Hand SanitizerALCOHOLDemoulas Super Markets, Incbfe6c08a-a584-4bfb-b28f-492333a0082a2026-02-03Warnings, Adverse reactionsExact identifier
ndc (package): 53942-370-16
ndc (product): 53942-370
ndc11 (package): 53942037016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNbfe6c08a-a584-4bfb-b28f-492333a0082a19
581662ethanol 0.7 ML/ML Topical GelSCDbfe6c08a-a584-4bfb-b28f-492333a0082a19
581662ethanol 70 % Topical GelSYbfe6c08a-a584-4bfb-b28f-492333a0082a19
581662ethyl alcohol 70 % Topical GelSYbfe6c08a-a584-4bfb-b28f-492333a0082a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-370-165394203701659 mL in 1 BOTTLE, PLASTIC (53942-370-16) 59 ml2015-11-220000-00-00NoNoCurrent