FDA.reportPublic FDA data

Advanced Hand Sanitizer

Product NDC
53942-439
Requested package NDC
53942-439-16
11-digit product format
539420439
Labeler code
53942
Product ID
53942-439_49f0b6fe-0d4d-4fa1-e063-6294a90a687b
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-24
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Advanced 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
0c84b49c-1473-422e-8d7b-da875c6a2c1aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-439-16Advanced Hand Sanitizer59 mL in 1 BOTTLE, DISPENSINGGEL5915
53942-439-34Advanced Hand Sanitizer236 mL in 1 BOTTLE, PUMPGEL23615
53942-439-45Advanced Hand Sanitizer946 mL in 1 BOTTLE, PLASTICGEL94615

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-439ADVANCED HAND SANITIZER (ETHYL ALCOHOL) GEL [DEMOULAS SUPER MARKETS, INC]13Current NDC, Legacy NDC, 3 package rows20240820_0c84b49c-1473-422e-8d7b-da875c6a2c1a.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
Advanced Hand SanitizerETHYL ALCOHOLDemoulas Super Markets, Inc0c84b49c-1473-422e-8d7b-da875c6a2c1a2026-02-03Warnings, Adverse reactionsExact identifier
ndc (package): 53942-439-16
ndc (product): 53942-439
ndc11 (package): 53942043916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN0c84b49c-1473-422e-8d7b-da875c6a2c1a15
581662ethanol 0.7 ML/ML Topical GelSCD0c84b49c-1473-422e-8d7b-da875c6a2c1a15
581662ethanol 70 % Topical GelSY0c84b49c-1473-422e-8d7b-da875c6a2c1a15
581662ethyl alcohol 70 % Topical GelSY0c84b49c-1473-422e-8d7b-da875c6a2c1a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-439-165394204391659 mL in 1 BOTTLE, DISPENSING (53942-439-16) 59 ml2015-06-240000-00-00NoNoCurrent