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_5dcec565-6dc8-ad3c-e063-6294a90a2893
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

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