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 9 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINE 5%Walgreen Company262ea2c8-f571-1c0b-e063-6394a90af20b2026-07-22WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
application number: M003
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
application number: M003
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
application number: M003
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
application number: M003
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsExact identifier
application number: M003
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
application number: M003
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
application number: M003
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
application number: M003
Midnight Magic Hand SanitizerALCOHOLScent Theory Products LLC5721d186-ec6d-fa26-e063-6294a90a76d22026-07-21WarningsExact identifier
application number: M003
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
application number: M003
Twisted Caramel Apple Hand SanitizerALCOHOLScent Theory Products LLC572a82e3-93ec-9af4-e063-6294a90a9c262026-07-21WarningsExact identifier
application number: M003
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
application number: M003
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
application number: M003
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact 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