FDA.reportPublic FDA data

91% Isopropyl Rubbing Alcohol

Product NDC
51628-4236
11-digit product format
516284236
Labeler code
51628
Product ID
51628-4236_298c769c-c128-d8be-e063-6294a90a8f1c
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
MY IMPORTS USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-14
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
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings • For external use only; flammable, keep away from fire or flame, heat, spark, electrical, etc. Ask a doctor before use if you have • Deep punctured 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 using this product if • Condition persists or gets worse Keep this drug out of the reach of children • In case of an accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately

Additional Listing Data#

Finished product
Yes
Brand name base
91% Isopropyl Rubbing 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
51628-4236-191% Isopropyl Rubbing Alcohol355 mL in 1 BOTTLELIQUID3554
51628-4236-291% Isopropyl Rubbing Alcohol473 mL in 1 BOTTLELIQUID4734
51628-4236-391% Isopropyl Rubbing Alcohol946 mL in 1 BOTTLELIQUID9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-423691% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [MY IMPORTS USA LLC]4Current NDC, Legacy NDC, 3 package rows20241220_d4d7adaf-c0fd-82fa-e053-2995a90ab9f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSNd4d7adaf-c0fd-82fa-e053-2995a90ab9f64
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCDd4d7adaf-c0fd-82fa-e053-2995a90ab9f64
582901isopropyl alcohol 91 % Topical SolutionSYd4d7adaf-c0fd-82fa-e053-2995a90ab9f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51628-4236-151628423601355 mL in 1 BOTTLE (51628-4236-1) 355 ml2021-01-140000-00-00NoNoCurrent
51628-4236-251628423602473 mL in 1 BOTTLE (51628-4236-2) 473 ml2021-01-140000-00-00NoNoCurrent
51628-4236-351628423603946 mL in 1 BOTTLE (51628-4236-3) 946 ml2021-01-140000-00-00NoNoCurrent