FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
10565-002
11-digit product format
105650002
Labeler code
10565
Product ID
10565-002_483384ed-390b-6ea7-e063-6394a90aaaaa
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-05
Substance
ISOPROPYL ALCOHOL
Active strength
70 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui808520

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
10565-002-04Isopropyl Alcohol118 mL in 1 BOTTLE, PLASTICSOLUTION11814
10565-002-08Isopropyl Alcohol237 mL in 1 BOTTLE, PLASTICSOLUTION23714
10565-002-16Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICSOLUTION47314
10565-002-32Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICSOLUTION94614
10565-002-99Isopropyl Alcohol3800 mL in 1 BOTTLE, PLASTICSOLUTION380014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Isopropyl AlcoholACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL SOLUTION [HYDROX LABORATORIES]1
Isopropyl AlcoholACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL SOLUTION [HYDROX LABORATORIES]1
WaterINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL SOLUTION [HYDROX LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-002ISOPROPYL ALCOHOL SOLUTION [HYDROX LABORATORIES]13Current NDC, Legacy NDC, 5 package rows20231027_2042cf29-52c5-4f1e-aae6-78e025994d18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN2042cf29-52c5-4f1e-aae6-78e025994d1814
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD2042cf29-52c5-4f1e-aae6-78e025994d1814
808520isopropyl alcohol 70 % Topical SolutionSY2042cf29-52c5-4f1e-aae6-78e025994d1814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-002-0410565000204118 mL in 1 BOTTLE, PLASTIC (10565-002-04) 118 ml2017-05-050000-00-00NoNoCurrent
10565-002-0810565000208237 mL in 1 BOTTLE, PLASTIC (10565-002-08) 237 ml2019-06-050000-00-00NoNoCurrent
10565-002-1610565000216473 mL in 1 BOTTLE, PLASTIC (10565-002-16) 473 ml2017-05-050000-00-00NoNoCurrent
10565-002-3210565000232946 mL in 1 BOTTLE, PLASTIC (10565-002-32) 946 ml2017-05-050000-00-00NoNoCurrent
10565-002-99105650002993800 mL in 1 BOTTLE, PLASTIC (10565-002-99) 3800 ml2017-05-050000-00-00NoNoCurrent