FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
55319-571
11-digit product format
553190571
Labeler code
55319
Product ID
55319-571_05087ec4-fccc-4736-92ea-a5411bf91848
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
91 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)abe3172e-5278-4bd0-8628-63f7b4c4e6fd2025-10-03WarningsExact 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 gastic disturbance 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 ALCOHOL91 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui582901

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-571-16Isopropyl alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4736
55319-571-32Isopropyl alcohol946 mL in 1 BOTTLE, PLASTICLIQUID9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-571ISOPROPYL ALCOHOL LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]4Current NDC, 2 package rows20250209_abe3172e-5278-4bd0-8628-63f7b4c4e6fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSNabe3172e-5278-4bd0-8628-63f7b4c4e6fd6
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCDabe3172e-5278-4bd0-8628-63f7b4c4e6fd6
582901isopropyl alcohol 91 % Topical SolutionSYabe3172e-5278-4bd0-8628-63f7b4c4e6fd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-571-1655319057116473 mL in 1 BOTTLE, PLASTIC (55319-571-16) 473 ml2023-07-01NoNoCurrent
55319-571-3255319057132946 mL in 1 BOTTLE, PLASTIC (55319-571-32) 946 ml2023-07-01NoNoCurrent