FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
11344-810
11-digit product format
113440810
Labeler code
11344
Product ID
11344-810_5b72f5ca-6a38-bb84-e063-6394a90a2e94
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
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

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
11344-810-08Isopropyl Alcohol3785 mL in 1 BOTTLE, PLASTICLIQUID37853
11344-810-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4733
11344-810-45Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICLIQUID9463
11344-810-72Isopropyl Alcohol295 mL in 1 BOTTLE, SPRAYLIQUID2953

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11344-810-45ML - Milliliter11344-8103cc75d21-f4e3-4639-9a29-aa54b7e2045412024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-810ISOPROPYL ALCOHOL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 4 package rows20250410_0bd995eb-a261-469b-8b7a-a5ff613ce48b.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 102 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - StrawberryALCOHOLGanzhou Olivee Cosmetic Co., Ltd.7c4bab88-af65-48c2-8440-3ba7b139c0132024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - AppleALCOHOLGanzhou Olivee Cosmetic Co., Ltd.362d3233-79ac-41d8-9991-b5fc75c6cae92024-09-10WarningsExact identifier
application number: M003
Danielle Creations Hand Sanitizer - PeachALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ad28fe19-2b81-40c2-8ffb-f9b09c79def82024-09-10WarningsExact identifier
application number: M003
Thompson AntisepticBENZALKONIUM CHLORIDEThompson0c009ed0-23b8-e4b3-e063-6394a90a723d2024-09-04WarningsExact identifier
application number: M003
Bravo Sierra - Antibacterial Body WipesBENZALKONIUM CHLORIDE WIPESUnderscore USA20ed5566-9014-e35b-e063-6294a90a003a2024-08-30WarningsExact identifier
application number: M003
BERRIS AND CREAMY SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30fc7f33-238c-42a3-93a1-72b98d303d9a2024-08-28WarningsExact identifier
application number: M003
MANGO SORBET SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.d44e43e1-717d-47a1-a152-45f12288cbd22024-08-28WarningsExact identifier
application number: M003
COCONUT VANILLA SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.574324ee-d98b-4939-889c-21ed04a4e46d2024-08-28WarningsExact identifier
application number: M003
STRAWBERRY SHORTCAKE SCENTED HAND SANITIZERALCOHOLGanzhou Olivee Cosmetic Co., Ltd.997d0ff0-96b4-4b91-87fc-8f67d9b5013c2024-08-28WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202dfeac-6e69-8667-e063-6294a90a26d22024-08-21WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsExact identifier
application number: M003
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
application number: M003
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
application number: M003
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
application number: M003
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
application number: M003
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
application number: M003
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
application number: M003
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN0bd995eb-a261-469b-8b7a-a5ff613ce48b3
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD0bd995eb-a261-469b-8b7a-a5ff613ce48b3
808520isopropyl alcohol 70 % Topical SolutionSY0bd995eb-a261-469b-8b7a-a5ff613ce48b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-810-08113440810083785 mL in 1 BOTTLE, PLASTIC (11344-810-08) 3785 ml1989-07-15NoNoCurrent
11344-810-4311344081043473 mL in 1 BOTTLE, PLASTIC (11344-810-43) 473 ml1989-07-15NoNoCurrent
11344-810-4511344081045946 mL in 1 BOTTLE, PLASTIC (11344-810-45) 946 ml1989-07-15NoNoCurrent
11344-810-7211344081072295 mL in 1 BOTTLE, SPRAY (11344-810-72) 295 ml2021-08-09NoNoCurrent