FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
81085-0002
11-digit product format
810850002
Labeler code
81085
Product ID
81085-0002_519bf30f-9975-4d96-b536-5ab1113651b9
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
CLOTH
Route
TOPICAL
Labeler
Sarnova, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-05
Substance
ISOPROPYL ALCOHOL
Active strength
70 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 ALCOHOLSarnova, Inc.62be13a6-da24-4ab0-b0f4-f2894324c20c2024-12-06WarningsExact 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 of flame. Do not use with electrocautery procedures or near eyes. Stop use and ask doctor if irritation or redness develop. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiND2M416302
Rxcui797544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81085-0002-1Isopropyl Alcohol0.8 mL in 1 POUCHCLOTH0.83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81085-0002ISOPROPYL ALCOHOL CLOTH [SARNOVA, INC.]3Current NDC, Legacy NDC, 1 package rows20241213_62be13a6-da24-4ab0-b0f4-f2894324c20c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Medicated PadSY62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Topical ClothSY62be13a6-da24-4ab0-b0f4-f2894324c20c3
797544isopropyl alcohol 70 % Topical SwabSY62be13a6-da24-4ab0-b0f4-f2894324c20c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81085-0002-181085000201.8 mL in 1 POUCH (81085-0002-1) 2022-04-050000-00-00NoNoCurrent