FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
10565-071
11-digit product format
105650071
Labeler code
10565
Product ID
10565-071_483361ef-6aaf-631d-e063-6394a90a0f59
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-19
Substance
ISOPROPYL ALCOHOL
Active strength
91 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL91 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
582901Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2f07464-6bd5-434c-8dea-0ba659c0e549Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-071-04Isopropyl Alcohol118 mL in 1 BOTTLE, PLASTICLIQUID11812
10565-071-08Isopropyl Alcohol237 mL in 1 BOTTLE, PLASTICLIQUID23712
10565-071-16Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47312
10565-071-32Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICLIQUID94612
10565-071-99Isopropyl Alcohol3785 mL in 1 BOTTLE, PLASTICLIQUID378512

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-071ISOPROPYL ALCOHOL LIQUID [HYDROX LABORATORIES]11Current NDC, Legacy NDC, 5 package rows20231027_f2f07464-6bd5-434c-8dea-0ba659c0e549.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 37 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact identifier
application number: M003
RELEEV Cold Sore TreatmentBENZALKONIUM CHLORIDEMerix Pharmaceutical Corp.fcef2fd3-2f32-4fb0-b396-ba4481ca4ccf2026-02-02WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 91%ISOPROPYL ALCOHOLLJ Pharma07cba887-a568-4b92-91ab-2e7831f24ab52026-01-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERite Aid Corporation2f8abb6f-460f-47bf-811d-734126aa3f0b2026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
application number: M003
Drs. pharmacy triple antibiotic plus lidocaineBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, LIDOCAINE OINTMENTOL PHARMA TECH, LLC49a73b0f-90d9-3a4b-e063-6294a90acfb02026-01-30WarningsExact identifier
application number: M003
HAND SANITIZER WIPESHAND SANITIZER WIPESShandong Baihe Sanitary Products Co., Ltd.49822c99-1181-ae42-e063-6394a90a82022026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
application number: M003
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
application number: M003
Liquid BandageBENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDEWal-Mart Stores, Inc.f3911d79-3169-71c3-e053-2a95a90ae8432026-01-29WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEAmerifoods Trading Co38b15693-7e5f-4c85-915e-9937ea018a832026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticFIRST AID ANTISEPTICAmerisource Bergen6719db46-a6e3-4f0a-828c-fe89a51879892026-01-29Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSNf2f07464-6bd5-434c-8dea-0ba659c0e54912
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCDf2f07464-6bd5-434c-8dea-0ba659c0e54912
582901isopropyl alcohol 91 % Topical SolutionSYf2f07464-6bd5-434c-8dea-0ba659c0e54912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-071-0410565007104118 mL in 1 BOTTLE, PLASTIC (10565-071-04) 118 ml2019-06-050000-00-00NoNoCurrent
10565-071-0810565007108237 mL in 1 BOTTLE, PLASTIC (10565-071-08) 237 ml2019-06-050000-00-00NoNoCurrent
10565-071-1610565007116473 mL in 1 BOTTLE, PLASTIC (10565-071-16) 473 ml2017-05-260000-00-00NoNoCurrent
10565-071-3210565007132946 mL in 1 BOTTLE, PLASTIC (10565-071-32) 946 ml2017-05-260000-00-00NoNoCurrent
10565-071-99105650071993785 mL in 1 BOTTLE, PLASTIC (10565-071-99) 3785 ml2017-05-260000-00-00NoNoCurrent