FDA.reportPublic FDA data

Isopropyl Alcohol 50%

Product NDC
10565-003
11-digit product format
105650003
Labeler code
10565
Product ID
10565-003_4833395f-8efc-471c-e063-6394a90a175e
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol 50%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-11
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
Isopropyl Alcohol 50%
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
10565-003-04Isopropyl Alcohol 50%118 mL in 1 BOTTLE, PLASTICSOLUTION11814
10565-003-08Isopropyl Alcohol 50%237 mL in 1 BOTTLE, PLASTICSOLUTION23714
10565-003-16Isopropyl Alcohol 50%473 mL in 1 BOTTLE, PLASTICSOLUTION47314
10565-003-32Isopropyl Alcohol 50%946 mL in 1 BOTTLE, PLASTICSOLUTION94614
10565-003-99Isopropyl Alcohol 50%3785 mL in 1 BOTTLE, PLASTICSOLUTION378514

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-003ISOPROPYL ALCOHOL 50% SOLUTION [HYDROX LABORATORIES]13Current NDC, Legacy NDC, 5 package rows20231027_930bb3a3-5ca3-414c-b4fb-c71ee17fc746.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN930bb3a3-5ca3-414c-b4fb-c71ee17fc74614
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD930bb3a3-5ca3-414c-b4fb-c71ee17fc74614
616456isopropyl alcohol 50 % Topical SolutionSY930bb3a3-5ca3-414c-b4fb-c71ee17fc74614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-003-0410565000304118 mL in 1 BOTTLE, PLASTIC (10565-003-04) 118 ml2019-06-110000-00-00NoNoCurrent
10565-003-0810565000308237 mL in 1 BOTTLE, PLASTIC (10565-003-08) 237 ml2019-06-110000-00-00NoNoCurrent
10565-003-1610565000316473 mL in 1 BOTTLE, PLASTIC (10565-003-16) 473 ml2019-06-110000-00-00NoNoCurrent
10565-003-3210565000332946 mL in 1 BOTTLE, PLASTIC (10565-003-32) 946 ml2019-06-110000-00-00NoNoCurrent
10565-003-99105650003993785 mL in 1 BOTTLE, PLASTIC (10565-003-99) 3785 ml2019-06-110000-00-00NoNoCurrent