FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
11344-864
11-digit product format
113440864
Labeler code
11344
Product ID
11344-864_5c141a3a-268a-1cea-e063-6294a90a6947
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
50 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 ALCOHOL50 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
11344-864-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11344-864-43ML - Milliliter11344-8643fbed488-9fa0-4b7f-a7a9-d47e109770b312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-864ISOPROPYL ALCOHOL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250410_4b7eca80-5f46-41be-abcb-a1f924667728.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 113 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
application number: M003
Antiseptic BZK ToweletteBENZALKONIUM CHLORIDECardinal Health 200, Inc.8dd79ffe-f742-438c-9814-612f900ad6a92023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltdf231a572-a99d-4146-afa3-e73ea1cee0272023-10-22WarningsExact identifier
application number: M003
Povidone Iodine Topical Solution PaintPOVIDONE IODINE 10%Jianerkang Medical Co., Ltd42778607-6170-4a5e-94d0-5e6cd064eec62023-10-22WarningsExact identifier
application number: M003
AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd76048b01-28f3-4e43-9da9-974b2b511a102023-10-22WarningsExact identifier
application number: M003
GENUINE FIRST AID Antiseptic Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.d25f02f1-268c-44d8-9a55-c6efcbe8eed12023-10-19WarningsExact identifier
application number: M003
Brompton and Langley Moisturizing Hand Sanitizer Lavnder VanillaALCOHOLGanzhou Olivee Cosmetic Co., Ltd.90bd3436-a8bc-4c19-a300-d59236a8de272023-10-19WarningsExact identifier
application number: M003
Up and Up 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTarget Corporationbecc8fe3-eaf5-4429-b462-a87dd09c4db82023-10-17WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.766ad4df-2100-4f26-bd8b-5c5a0918698e2023-10-13WarningsExact identifier
application number: M003
GoodSense Alcohol SwabsISOPROPYL ALCOHOLGeiss, Destin and Dunn968bab9f-5b74-270b-e053-2995a90a0df42023-10-13WarningsExact identifier
application number: M003
Henry Schein Povidone-Iodine SwabsticksPOVIDONE-IODINEHenry Schein, Inc.5854f241-6cfc-4e5a-ba72-92dd0703f7282023-10-13WarningsExact identifier
application number: M003
DawnMist Alcohol Hand SanitizerALCOHOLDukal LLCa2df96a9-8514-6839-e053-2a95a90a94172023-10-13WarningsExact identifier
application number: M003
DUKAL STING RELIEF PADBENZOCAINEDukal LLC67c1ddc7-8fde-4431-84cb-f757682d5f3e2023-10-13WarningsExact identifier
application number: M003
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDEAcme United Corporation07245b54-b193-178e-e063-6394a90a25812023-10-09WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLRejoice International Corp.06dc1730-216a-8b4d-e063-6294a90a41842023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 1.8oz with extra clip originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dcf8dc-0831-475e-e063-6394a90a9fef2023-10-04WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk originalETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.06dd2427-097c-b0fa-e063-6294a90a4f822023-10-04WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2600350isopropyl alcohol 50 % Topical SprayPSN4b7eca80-5f46-41be-abcb-a1f9246677283
2600350isopropyl alcohol 0.5 ML/ML Topical SpraySCD4b7eca80-5f46-41be-abcb-a1f9246677283
2600350isopropyl alcohol 50 % Topical SpraySY4b7eca80-5f46-41be-abcb-a1f9246677283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-864-4311344086443473 mL in 1 BOTTLE, PLASTIC (11344-864-43) 473 ml1989-07-15NoNoCurrent