FDA.reportPublic FDA data

Isopropyl Alcohol with Wintergreen 50%

Product NDC
10565-007
11-digit product format
105650007
Labeler code
10565
Product ID
10565-007_48339b38-6f43-9dec-e063-6394a90a1bda
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol with Wintergreen 50%
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-19
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 with Wintergreen 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-007-04Isopropyl Alcohol with Wintergreen 50%118 mL in 1 BOTTLE, PLASTICSOLUTION11810
10565-007-08Isopropyl Alcohol with Wintergreen 50%237 mL in 1 BOTTLE, PLASTICSOLUTION23710
10565-007-16Isopropyl Alcohol with Wintergreen 50%473 mL in 1 BOTTLE, PLASTICSOLUTION47310
10565-007-32Isopropyl Alcohol with Wintergreen 50%946 mL in 1 BOTTLE, PLASTICSOLUTION94610
10565-007-99Isopropyl Alcohol with Wintergreen 50%3785 mL in 1 BOTTLE, PLASTICSOLUTION378510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-007ISOPROPYL ALCOHOL WITH WINTERGREEN 50% SOLUTION [HYDROX LABORATORIES]9Current NDC, Legacy NDC, 5 package rows20231027_3a15a900-2b48-487f-b252-a1a1e0d0abfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN3a15a900-2b48-487f-b252-a1a1e0d0abfc10
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD3a15a900-2b48-487f-b252-a1a1e0d0abfc10
616456isopropyl alcohol 50 % Topical SolutionSY3a15a900-2b48-487f-b252-a1a1e0d0abfc10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-007-0410565000704118 mL in 1 BOTTLE, PLASTIC (10565-007-04) 118 ml2019-06-190000-00-00NoNoCurrent
10565-007-0810565000708237 mL in 1 BOTTLE, PLASTIC (10565-007-08) 237 ml2019-06-190000-00-00NoNoCurrent
10565-007-1610565000716473 mL in 1 BOTTLE, PLASTIC (10565-007-16) 473 ml2019-06-190000-00-00NoNoCurrent
10565-007-3210565000732946 mL in 1 BOTTLE, PLASTIC (10565-007-32) 946 ml2019-06-190000-00-00NoNoCurrent
10565-007-99105650007993785 mL in 1 BOTTLE, PLASTIC (10565-007-99) 3785 ml2019-06-190000-00-00NoNoCurrent