FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
55319-569
11-digit product format
553190569
Labeler code
55319
Product ID
55319-569_daf95828-12cf-4edf-9641-4bc677565ee9
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616456Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f1c3e24-ea71-4634-9ec1-670349b43a50Available on FDA.report

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
55319-569-16Isopropyl alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-569ISOPROPYL ALCOHOL LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 1 package rows20250209_2f1c3e24-ea71-4634-9ec1-670349b43a50.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 73 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLMY IMPORTS USA LLC3a2a4539-30eb-7451-e063-6294a90a2c222025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLMY IMPORTS USA LLC3a2a4fab-6776-7359-e063-6294a90a85242025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a186822-025c-6970-e063-6394a90a5dc12025-07-16WarningsExact identifier
application number: M003
X3 Clean Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.5a0aea16-b1ff-4fa1-a292-0f14474745932025-07-15WarningsExact identifier
application number: M003
Meridian Wrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.84aada12-f26e-4dc9-a256-8746c6431f612025-07-15WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.2c124769-a044-4d62-9325-89d5310a42de2025-07-15WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 461225539cbe8-1d0f-41f8-9c5d-a9af7f28eed12025-07-15WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a417a8-afec-f893-e063-6394a90a70ae2025-07-11WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a4aecf-1e74-4589-e063-6394a90a34fb2025-07-11WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a57c83-5ea6-5b36-e063-6294a90a284d2025-07-11WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn CareHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions3cfa43a0-402b-4b32-94ff-2b2e2e6565c22025-07-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 70000bf355e30-ad2f-4f93-9d77-8efd6a908e582025-07-11WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70 Percent WintergreenISOPROPYL ALCOHOLBest Choice (Valu Merchandisers Company)abcc7941-e521-4ad6-89df-0b965b634eb32025-07-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health (Leader) 700005ffa8ecf-1349-4758-8d47-e9a96d2ddaee2025-07-11WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39904847-ed55-f4a3-e063-6294a90a85a12025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.397a897a-baab-d209-e063-6294a90aac652025-07-10WarningsExact identifier
application number: M003
XTRA Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.398fd961-d5e6-9d40-e063-6294a90a5be52025-07-10WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Fresh LemonBENZALKONIUM CHLORIDEMY IMPORTS USA LLC.39901012-e1a1-c6e3-e063-6294a90ab41f2025-07-10WarningsExact identifier
application number: M003
AerowipeALCOHOL WIPEAero Healthcare34c93704-9f3c-6746-e054-00144ff8d46c2025-07-10WarningsExact identifier
application number: M003
Walgreens 10 Povidone-Iodine SolutionPOVIDONE-IODINEWALGREEN COMPANYa7b635d0-9109-4cd6-9b96-fba0d76464fc2025-07-10WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN2f1c3e24-ea71-4634-9ec1-670349b43a505
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD2f1c3e24-ea71-4634-9ec1-670349b43a505
616456isopropyl alcohol 50 % Topical SolutionSY2f1c3e24-ea71-4634-9ec1-670349b43a505

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-569-1655319056916473 mL in 1 BOTTLE, PLASTIC (55319-569-16) 473 ml2023-07-01NoNoCurrent