FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
53329-800
11-digit product format
533290800
Labeler code
53329
Product ID
53329-800_4a8e4d79-d373-d70e-e063-6394a90a643d
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-02-16
Substance
ISOPROPYL ALCOHOL
Active strength
70 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 ALCOHOL70 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
808520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52a8b96e-dd4f-449e-b819-6f3ec5a27fb4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-800-06Isopropyl Alcohol473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-800-06ML - Milliliter53329-800aa420075-e459-4900-b58d-022bd63fd60c12018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL LIQUID [MEDLINE INDUSTRIES, INC.]2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL LIQUID [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL LIQUID [MEDLINE INDUSTRIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-800ISOPROPYL ALCOHOL LIQUID [MEDLINE INDUSTRIES, LP]6Current NDC, Legacy NDC, 1 package rows20241207_52a8b96e-dd4f-449e-b819-6f3ec5a27fb4.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 32 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Universal Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC183efdc2-cf3e-4f06-b292-0cfd097418b32026-02-23WarningsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS0cc6b001-4982-40ee-a476-151f86c14a8e2026-02-19WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDESave-A-Lot Food Stores Ltde279b23d-6779-4f04-a93c-1c2a495596392026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEMeijer, Inc.193292da-390b-4430-91b1-1d159ac505072026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMeijer, Inc.4989f1cd-4555-405a-a5f8-8714d472983c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETarget Corporation78693ec1-d725-408c-bb95-2261faad84ac2026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Travel Wipes Fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLCea77be5e-7c69-4787-b39a-4753b002dbbd2026-02-18WarningsExact identifier
application number: M003
Travel Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCdd046146-fda7-438c-98ca-96ea1dd0ae0b2026-02-18WarningsExact identifier
application number: M003
Benzalkonium chlorideFIRST AID ANTISEPTIC FOAMTarget Corporation4599eb25-2877-fc62-e063-6294a90a5d182026-02-18Warnings, Adverse reactionsExact identifier
application number: M003
Konix Povidone Iodine Topical AntisepticPOVIDONE-IODINETURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS8a9848b0-19df-455a-9984-5ea2e5ce1b9f2026-02-17WarningsExact identifier
application number: M003
Wintergreen 91 - Iron LabETHYL ALCOHOLIron Lab SA de CV323a0717-0d61-c911-e063-6394a90a48542026-02-17WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b2f5d-34b9-8f5b-e063-6394a90a59d52026-02-17WarningsExact identifier
application number: M003
50 Ethyl Rubbing AlcoholALCOHOLIron Lab SA de CV323b7ff8-91ce-c7a4-e063-6394a90a69fc2026-02-17WarningsExact identifier
application number: M003
70 Alcohol Hand SanitizerALCOHOLIron Lab SA de CV323c06d5-c984-39b8-e063-6294a90a0d3f2026-02-17WarningsExact identifier
application number: M003
50 Wintergreen AlcoholALCOHOLIron Lab SA de CV323baeb1-e3ee-ec70-e063-6294a90a30f02026-02-17WarningsExact identifier
application number: M003
70 Rubbing Ethyl AlcoholALCOHOLIron Lab SA de CV323be8b4-4588-e2a6-e063-6394a90ab68b2026-02-17WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEUnited Natural Foods, Inc. dba UNFI8a44aa29-58d6-4971-b572-4579f03ed2272026-02-17Warnings, Adverse reactionsExact identifier
application number: M003
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC087ac43c-1076-d1e2-e063-6294a90a58592026-02-16WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN52a8b96e-dd4f-449e-b819-6f3ec5a27fb49
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD52a8b96e-dd4f-449e-b819-6f3ec5a27fb49
808520isopropyl alcohol 70 % Topical SolutionSY52a8b96e-dd4f-449e-b819-6f3ec5a27fb49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-800-0653329080006473 mL in 1 BOTTLE (53329-800-06) 473 ml2009-02-160000-00-00NoNoCurrent