FDA.reportPublic FDA data

NEXXGEN 50% RUBBING ALCOHOL

Product NDC
83629-019
11-digit product format
836290019
Labeler code
83629
Product ID
83629-019_6574f32f-35e2-4b35-9e67-abe99f47a352
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
A & A Nexxgen LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-03
Substance
ISOPROPYL ALCOHOL
Active strength
50 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
NEXXGEN 50% RUBBING ALCOHOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui616456

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83629-019-12NEXXGEN 50% RUBBING ALCOHOL355 mL in 1 BOTTLE, PLASTICLIQUID3553
83629-019-16NEXXGEN 50% RUBBING ALCOHOL473 mL in 1 BOTTLE, PLASTICLIQUID4733
83629-019-32NEXXGEN 50% RUBBING ALCOHOL946 mL in 1 BOTTLE, PLASTICLIQUID9463

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83629-019NEXXGEN 50% RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [A & A NEXXGEN LLC]2Current NDC, 3 package rows20241129_d48232ab-ab55-488a-9cc1-77c8d0ba992e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNd48232ab-ab55-488a-9cc1-77c8d0ba992e3
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDd48232ab-ab55-488a-9cc1-77c8d0ba992e3
616456isopropyl alcohol 50 % Topical SolutionSYd48232ab-ab55-488a-9cc1-77c8d0ba992e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83629-019-1283629001912355 mL in 1 BOTTLE, PLASTIC (83629-019-12) 355 ml2026-01-22NoNoCurrent
83629-019-1683629001916473 mL in 1 BOTTLE, PLASTIC (83629-019-16) 473 ml2026-01-22NoNoCurrent
83629-019-3283629001932946 mL in 1 BOTTLE, PLASTIC (83629-019-32) 946 ml2024-01-03NoNoCurrent