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
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl alcoholISOPROPYL ALCOHOLFamily Dollar (FAMILY WELLNESS)2f1c3e24-ea71-4634-9ec1-670349b43a502025-10-01WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only if taken internally, serious gastric disturbances will result Flammable, Keep away from fire or flame. use only in a well-ventilated area; fumes may be toxic Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns. When using this product do not get into eyes do not apply over large areas of the body do not use longer than one week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Additional Listing Data#

Finished product
Yes
Brand name base
Isopropyl alcohol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui616456

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

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