FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
53329-797
11-digit product format
533290797
Labeler code
53329
Product ID
53329-797_4a8e39e0-22af-cf0c-e063-6394a90a7e19
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-08-06
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
26e10080-d389-4994-e054-00144ff8d46cAvailable on FDA.report

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
53329-797-06Isopropyl alcohol473 mL in 1 BOTTLESOLUTION4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-797ISOPROPYL ALCOHOL SOLUTION [MEDLINE INDUSTRIES, LP]6Current NDC, Legacy NDC, 1 package rows20240531_26e10080-d389-4994-e054-00144ff8d46c.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 20 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Beaded Wristlet Vanilla BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5227736d-c13b-652b-e063-6394a90adc6b2026-05-19WarningsExact identifier
application number: M003
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
application number: M003
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet Lily WaterALCOHOLShenzhen Lantern Scicence Co.,Ltd.523a8084-a67b-77da-e063-6394a90a4ff92026-05-19WarningsExact identifier
application number: M003
Caring Mill BZK TowelettesBENZALKONIUM CHLORIDEFSA Store Inc.51f20e04-3efb-9dbf-e063-6394a90a4aca2026-05-18WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Fall Harvest AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.5213f632-33a0-aa45-e063-6294a90a71a02026-05-18WarningsExact identifier
application number: M003
Meijer Hand Sanitizer Fall Harvest Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.522413eb-d7e3-65ea-e063-6394a90a942b2026-05-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet RosewateALCOHOLShenzhen Lantern Scicence Co.,Ltd.52245438-751b-b52e-e063-6394a90aeb472026-05-18WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER TROPICAL PUNCHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27d8-81a3-e063-6294a90afc802026-05-17WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.520e7b2b-e24e-5ce7-e063-6294a90a986d2026-05-17WarningsExact identifier
application number: M003
Wish Alcohol PadISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.51f87ed7-04ae-136a-e063-6294a90a95002026-05-16WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
application number: M003
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLShenzhen Lantern Scicence Co.,Ltd.51ae8f8d-8969-9605-e063-6394a90a42252026-05-13WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLShenzhen Lantern Scicence Co.,Ltd.51af80be-dcc8-f5c3-e063-6394a90a32542026-05-13WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN26e10080-d389-4994-e054-00144ff8d46c8
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD26e10080-d389-4994-e054-00144ff8d46c8
582901isopropyl alcohol 91 % Topical SolutionSY26e10080-d389-4994-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-797-0653329079706473 mL in 1 BOTTLE (53329-797-06) 473 ml2015-08-060000-00-00NoNoCurrent