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 94 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEXXGEN 70% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC8d1a5c98-8169-4f40-8601-a6f6bbbbebe72024-12-09WarningsExact identifier
application number: M003
NEXXGEN 91% RUBBING ALCOHOL with WintergreenISOPROPYL ALCOHOLA & A Nexxgen LLC12b8c85a-da0c-47a1-9531-c9f2858c4f312024-12-09WarningsExact identifier
application number: M003
NEXXGEN 91% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLC609267da-3ee6-4bd3-aecf-610d9047774c2024-12-09WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLSarnova, Inc.62be13a6-da24-4ab0-b0f4-f2894324c20c2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Globalb84075db-be0c-4265-b262-825bc6ade9d82024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global47276148-08e5-400e-94ac-d2d9db423b512024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticALCOHOLASP Global9aca3f89-cdde-430c-8eb6-43a3ac3fc0df2024-12-06WarningsExact identifier
application number: M003
Instant Hand AntisepticBENZALKONIUM CHLORIDEASP Global4eef4b0f-9209-45a4-8a0e-7891fc380fe52024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 1.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2998b2bd-6208-4cb4-982b-0ffb97d7d75d2024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.68003c71-5959-476f-b252-1f131e9305e22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.e35e468a-1f0c-4a3f-ac6a-cd55a72f3cc22024-12-05WarningsExact identifier
application number: M003
MERIDIAN UNWARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.b621b4cd-20db-44d8-b114-a977deea8eb42024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 0.5BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.c3a053ba-65fe-4540-9c81-29700cda5efa2024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3 OZBENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.2989afeb-8451-4a72-8456-195cd5117a412024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 1.25BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.17092ebf-8e57-4e1a-9bba-87a662c361c02024-12-05WarningsExact identifier
application number: M003
MERIDIAN WARPPED ANTIBACTERIAL DEODORANT 3BENZETHONIUM CHLORIDEYangzhou H&R Plastic Daily Chemical Co., Ltd.3ed3332e-f888-4b9c-aab7-99f8719b835e2024-12-05WarningsExact identifier
application number: M003
OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d05fbe85-26de-0d24-e053-2a95a90ab5cb2024-12-05WarningsExact identifier
application number: M003
OPS AB ANTIBACTERIAL FOAMINGBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.615921dd-46e5-403c-9ed3-f30beb0c0bb92024-12-05WarningsExact identifier
application number: M003
BLACK OPS 70 PERCENT ALCOHOL FOAMING SKIN SANITIZERETHYL ALCOHOLArcher Manufacturing, Inc.d334b7f0-01dc-7f59-e053-2a95a90a06b52024-12-05WarningsExact identifier
application number: M003
BLACK OPS INSTANT HAND SANITIZERBENZALKONIUM CHLORIDEArcher Manufacturing, Inc.d3366750-18b8-1194-e053-2995a90a43592024-12-05WarningsExact 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