FDA.reportPublic FDA data

Isopropyl Alcohol

Product NDC
50804-804
11-digit product format
508040804
Labeler code
50804
Product ID
50804-804_509b6b87-2269-6235-e063-6294a90afdee
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Perrigo Direct, Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-22
Substance
ISOPROPYL ALCOHOL
Active strength
91 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50804-80450804-804-45DDiscontinued by firm2026-10-15

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 packagepackage50804-80450804-804-45DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50804-80450804-804-45DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Isopropyl Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL91 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ND2M416302Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582901Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11d89d11-103e-4ef6-a996-65cff67f9b32Available on FDA.report

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
50804-804-43Isopropyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID47317
50804-804-45Isopropyl Alcohol946 mL in 1 PACKAGELIQUID94617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-804-43ML - Milliliter50804-804d997a60b-1d41-4047-bc22-6aeb08032f2b12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL LIQUID [GEISS,DESTINE & DUNN, INC]1
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL LIQUID [GEISS,DESTINE & DUNN, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL LIQUID [GEISS,DESTINE & DUNN, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-804ISOPROPYL ALCOHOL LIQUID [PERRIGO DIRECT, INC]14Current NDC, Legacy NDC, 2 package rows20240920_11d89d11-103e-4ef6-a996-65cff67f9b32.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentian VioletGENTIAN VIOLETVitamex USA, Corp21742061-fc0b-f750-e063-6394a90a75082026-08-26WarningsExact identifier
application number: M003
MercurochromeBENZALKONIUM CHLORIDEVitamex USA, Corp21652b11-715d-0c54-e063-6294a90a88552026-08-26WarningsExact identifier
application number: M003
Scentsational Square Hand SanitizerHAND SANITIZERRaining Rose, Inc.59f9bacf-80dc-3468-e063-6294a90a0ae12026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fa27b4-dfd4-720b-e063-6394a90af6592026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fb22d6-f6a4-42cd-e063-6394a90a859a2026-08-26WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59fbb054-461e-aa6e-e063-6394a90a470c2026-08-26WarningsExact identifier
application number: M003
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEYour Military Exchangesa71734c6-6b92-4d3d-84d1-a07f592fa8282026-08-25Warnings, Adverse reactionsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e742a6-61f9-59f7-e063-6394a90a87382026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59e7dfb1-49b5-d2be-e063-6394a90a04d82026-08-25WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d3c369-86aa-8ebd-e063-6394a90aa8062026-08-24WarningsExact identifier
application number: M003
Biopure Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.59d7fc3c-3a93-153d-e063-6394a90ac6472026-08-24WarningsExact identifier
application number: M003
Be Smart Get Prepared Hand SanitizerALCOHOLTotal Resources International, Inc23d0dc62-28d6-4d1f-a7d5-4b14f5c9fb1e2026-08-24WarningsExact identifier
application number: M003
ClaravieBENZALKONIUM CHLORIDEGentell LLC59887af3-9b22-9664-e063-6294a90a57c62026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light blue 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a96f0-33fe-40aa-e063-6394a90aeacb2026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light green 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598a165a-90ff-e00c-e063-6394a90a33512026-08-21WarningsExact identifier
application number: M003
Family Beauty Antibacterial Hand WipesBENZALKONIUM CHLORIDEZhejiang Bright Care Co., Ltd.6ff604f7-4011-4f0e-aa2d-a46e1a973d132026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light purple 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598b7bb8-0d2e-a66f-e063-6294a90a45b82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light yellow 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598bf8cd-2a79-8b56-e063-6394a90a42a82026-08-21WarningsExact identifier
application number: M003
hand sanitizer- light pink 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.598c41f0-908d-df52-e063-6394a90a3c8d2026-08-21WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582901isopropyl alcohol 91 % Topical SolutionPSN11d89d11-103e-4ef6-a996-65cff67f9b3217
582901isopropyl alcohol 0.91 ML/ML Topical SolutionSCD11d89d11-103e-4ef6-a996-65cff67f9b3217
582901isopropyl alcohol 91 % Topical SolutionSY11d89d11-103e-4ef6-a996-65cff67f9b3217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-804-4350804080443473 mL in 1 BOTTLE, PLASTIC (50804-804-43) 473 ml2011-04-220000-00-00NoNoCurrent
50804-804-4550804080445946 mL in 1 PACKAGE (50804-804-45) 946 ml2011-04-220000-00-00NoNoCurrent