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 53 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLCcef2d3d4-bd5f-4f2a-bb2d-5292b78501c12025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC90d6fe21-7b41-4429-8c03-4d35e66a3b292025-11-28WarningsExact identifier
application number: M003
Klean FreakBENZALKONIUM CHLORIDEKLEAN FREAK, LLC87aaabb6-d121-464f-993d-5182de13d49e2025-11-28WarningsExact identifier
application number: M003
FF SILICONE SPRY SANI PPKFF SILICONE SPRY SANI PPKZHEJIANG JINGHUI COSMETICS SHARE CO.,LTD4493c534-187e-f680-e063-6294a90aacdb2025-11-27WarningsExact identifier
application number: M003
Walgreen Maximum strength pain relieving cleansingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWALGREENS CO.9a0443a2-f1a9-482d-b5ee-abe983e4ae322025-11-26WarningsExact identifier
application number: M003
WalgreensFIRST AID ANTISEPTICWalgreensae731d28-8530-4dd0-aef7-b25f784b47772025-11-26WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.44677bab-41ea-3392-e063-6394a90a61872025-11-25WarningsExact identifier
application number: M003
Antibacterial Hand Sanitizer Spray.ALCOHOLHAIAN KANGRUI TEXTILE CO., LTD.3c242e55-4585-9f07-e063-6294a90a6fb42025-11-25WarningsExact identifier
application number: M003
ORANGE HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.a9c1e4f6-e354-4624-a902-8c9154ea47232025-11-25WarningsExact identifier
application number: M003
COCONUT HAND SANITIZER aloe and vitamin EALCOHOLGanzhou Olivee Cosmetic Co., Ltd.40d7fb84-4b39-440d-a590-8aaf8ec312d72025-11-25WarningsExact identifier
application number: M003
Alcohol WipesALCOHOL WIPESGuangzhou Baihua Co., Ltd4453997f-b885-ad2d-e063-6294a90a2c8e2025-11-24WarningsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEVALU MERCHANDISERS, COc79540fe-b972-41a4-a215-e21e30b903d12025-11-24WarningsExact identifier
application number: M003
Lights SwabsticksISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4435a4e6-46ae-f49b-e063-6394a90a1d9e2025-11-22WarningsExact identifier
application number: M003
FloraMedis Hand SanitizerHAND SANITIZERSichuan Pengtai Qifan Technology Co., Ltd4415ca9f-10b1-88f7-e063-6294a90a2e092025-11-21WarningsExact identifier
application number: M003
AMERIDERMBZKSHIELD LINE LLC440b711a-de12-2d28-e063-6394a90ae42a2025-11-20WarningsExact identifier
application number: M003
Recens FoamALCOHOLCertus Medical, Inc.ea384dfc-c894-3124-e053-2a95a90a81c22025-11-20WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer (Peach Peony, Dragonfruit Paradise, Coastal Fleur)ALCOHOLScent Theory Products LLC440f0a52-de0a-8f44-e063-6294a90a18b52025-11-20WarningsExact identifier
application number: M003
MK Alcohol Prep Pads LargeISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltdf1ff70d7-d0f2-45db-96e9-883b54c6e4412025-11-20WarningsExact identifier
application number: M003
Aero Care Handy Quat Antiseptic HandwashBENZALKONIUM CHLORIDEABC Compounding Co., Inc.ab015f59-160a-47d1-8d2f-fbe1b23177b32025-11-19WarningsExact identifier
application number: M003
FastALCOHOLABC Compounding Co., Inc.4f958247-5370-4250-b2eb-39faa97199392025-11-19WarningsExact 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