FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
11344-408
11-digit product format
113440408
Labeler code
11344
Product ID
11344-408_5b876e48-cf23-6306-e063-6294a90aa412
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-408-08Isopropyl Alcohol3785 mL in 1 BOTTLE, PLASTICLIQUID37853
11344-408-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-408ISOPROPYL ALCOHOL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 2 package rows20250410_8fffd9f9-8895-4760-890d-07f04a840b73.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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003
Health Mart Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLStrategic Sourcing Services LLC72eeb3e6-c0a1-4b18-87f1-8db06f9bd1112023-12-20WarningsExact identifier
application number: M003
Health Mart Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCcbe02fa1-c167-4b77-8f63-817362090e192023-12-20WarningsExact identifier
application number: M003
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
application number: M003
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLChain Drug Market Association55c970ed-13a9-4ea2-a8cb-aaf14d3a214d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodides TinctureETHYL ALCOHOLChain Drug Market Association71aedfd5-e81f-4b69-b163-527ff1ce30b12023-12-20WarningsExact identifier
application number: M003
Quality Choice MerthiolateBENZALKONIUM CHLORIDEChain Drug Market Association5b7303b9-b8c4-4e7c-876f-70ed764430552023-12-20WarningsExact identifier
application number: M003
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact identifier
application number: M003
Harris Teeter Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHarris Teeter, LLC5c88d7cb-2917-54e9-e053-2991aa0a0bd92023-12-20WarningsExact identifier
application number: M003
CVS IodineIODINE, SODIUM IODIDE AND ALCOHOLCVS Pharmacyb11db4e5-6a6d-4d4a-b980-600692b541762023-12-20WarningsExact identifier
application number: M003
CVS Povidone-IodinePOVIDONE IODINECVS Pharmacy402d571f-e1e8-43fd-9e7b-05aab18379052023-12-20WarningsExact identifier
application number: M003
Sanitizing wipes with aloe Grapefruit GroveALCOHOLThe Honest Companyfaa3690b-ce0d-43d4-9e5c-f2ce77daabe72023-12-19WarningsExact identifier
application number: M003
Sanitizing Wipes Fragrance FreeALCOHOLThe Honest Company0ce3e7ee-aa50-16bc-e063-6294a90a527d2023-12-19WarningsExact identifier
application number: M003
sunmark Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC46da2750-37d1-4ed1-baf3-1fd4266175672023-12-19WarningsExact identifier
application number: M003
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
application number: M003
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLStrategic Sourcing Services LLC515dd733-1b44-4df0-928f-a3b202b5f9c22023-12-19WarningsExact identifier
application number: M003
Sunmark Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLC92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e2023-12-19WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN8fffd9f9-8895-4760-890d-07f04a840b733
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD8fffd9f9-8895-4760-890d-07f04a840b733
582901isopropyl alcohol 91 % Topical SolutionSY8fffd9f9-8895-4760-890d-07f04a840b733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-408-08113440408083785 mL in 1 BOTTLE, PLASTIC (11344-408-08) 3785 ml1989-07-15NoNoCurrent
11344-408-4311344040843473 mL in 1 BOTTLE, PLASTIC (11344-408-43) 473 ml1989-07-15NoNoCurrent