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

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
Isopropyl Alcohol 50%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
930bb3a3-5ca3-414c-b4fb-c71ee17fc746Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 80 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Spicy CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b8e946-b52b-fa2e-e063-6294a90ae1a72025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pine ForestALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b920b7-91b4-52df-e063-6394a90a745e2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitize MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b95351-5115-7200-e063-6394a90a58402025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Alcohol Prep PadISOPROPYL ALCOHOLTotal Resources International, Inc6f2a4cb9-eea9-4894-b774-759f27b6f9a82025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC9c85129b-29fa-4393-a9b4-b8ea1ba5be542025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLTARGET Corporationf4ea4aa4-42c6-456b-9908-24f256d4a7692025-04-14WarningsExact identifier
application number: M003
Isopropyl alcohol WintergreenISOPROPYL ALCOHOLStrategic Sourcing Services LLC8dac7168-0140-470f-bf66-fd0aed519b382025-04-14WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC227b9292-0be7-47ef-ac8e-a9a8cc2fb4162025-04-14WarningsExact identifier
application number: M003
Be Smart Get Prepared Antiseptic WipeBENZALKONIUM CHLORIDETotal Resources International, Incf2151af3-d76a-490f-90ff-728c350fe1682025-04-11WarningsExact identifier
application number: M003

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