FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
53943-804
11-digit product format
539430804
Labeler code
53943
Product ID
53943-804_f92a9b72-1cd4-4890-b82f-ec63b9e610b5
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Discount Drug Mart
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-11-30
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53943-804DDiscontinued by firm2026-10-05
excluded packagepackage53943-80453943-804-43DDiscontinued by firm2026-10-05
excluded packagepackage53943-80453943-804-45DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53943-80453943-804-45DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53943-80453943-804-45DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-804-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47315
53943-804-45Isopropyl Alcohol946 mL in 1 BOTTLE, PLASTICLIQUID94615

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL LIQUID [DISCOUNT DRUG MART]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-804ISOPROPYL ALCOHOL LIQUID [DISCOUNT DRUG MART]13Legacy NDC, 2 package rows20240910_83dfcf29-e065-4ed0-abcc-3bafde91786c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN83dfcf29-e065-4ed0-abcc-3bafde91786c15
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD83dfcf29-e065-4ed0-abcc-3bafde91786c15
582901isopropyl alcohol 91 % Topical SolutionSY83dfcf29-e065-4ed0-abcc-3bafde91786c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-804-4353943080443473 mL in 1 BOTTLE, PLASTIC (53943-804-43) 473 ml2010-11-300000-00-00NoNoCurrent
53943-804-4553943080445946 mL in 1 BOTTLE, PLASTIC (53943-804-45) 946 ml2010-11-300000-00-00NoNoCurrent