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 28 of 117 · 2,333 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da93596-ec59-1e56-e063-6394a90afceb2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da951ff-37fe-4ca4-e063-6394a90a4baf2026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da9cb12-3aaf-c0f9-e063-6394a90ae4a42026-03-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da8a7b6-d147-87c3-e063-6394a90a784c2026-03-22WarningsExact identifier
application number: M003
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M003
MediChoice OB CleansingBENZALKONIUM CHLORIDEO&M HALYARD, INC.ed38fb97-b67d-430b-8f6b-4fc78c16aead2026-03-17WarningsExact identifier
application number: M003
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
application number: M003
MedPride 91% Rubbing AlcoholISOPROPYL ALCOHOLShield Line LLCe6ffe41e-efdc-0e0a-e053-2995a90a9e6a2026-03-17WarningsExact identifier
application number: M003
MedPRIDE with Wintergreen OilISOPROPYL ALCOHOLShield Line LLC57ac1a5c-758a-4422-8795-40391584434a2026-03-17WarningsExact 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