FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Product NDC
51628-4233
11-digit product format
516284233
Labeler code
51628
Product ID
51628-4233_298c769c-c105-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
2020-06-18
Substance
ISOPROPYL ALCOHOL
Active strength
50 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 RUBBING ALCOHOL 50% WITH WINTERGREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOPROPYL ALCOHOL50 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
616456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4d77ec3-4930-74f0-e053-2a95a90a962aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-4233-1ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN355 mL in 1 BOTTLE, PLASTICLIQUID3556
51628-4233-2ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4736
51628-4233-3ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN946 mL in 1 BOTTLE, PLASTICLIQUID9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-4233ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [MY IMPORTS USA, LLC]6Current NDC, Legacy NDC, 3 package rows20241220_d4d77ec3-4930-74f0-e053-2a95a90a962a.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 107 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationbd46efc8-0b36-0931-e053-2a95a90adb6f2024-01-17WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationbc914c36-e0f0-18c5-e053-2a95a90a894e2024-01-17WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca2b641-7fbc-5462-e053-2995a90ae2b42024-01-17WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca4545e-d477-270a-e053-2995a90a0ed62024-01-17WarningsExact identifier
application number: M003
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsExact identifier
application number: M003
MyMedic Oral Pain Relief GelBENZOCAINENantong Health & Beyond Hygienic Products Inc.0f0b6157-ec18-13ef-e063-6294a90a2e0c2024-01-16WarningsExact identifier
application number: M003
MyMedic Super SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.0f0c535d-8ff3-4799-e063-6394a90a70632024-01-16WarningsExact identifier
application number: M003
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
application number: M003
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
application number: M003
Thompson Hand SanitizerETHYL ALCOHOLThompsondeada606-8a82-9eeb-e053-2a95a90a9e6d2024-01-16WarningsExact identifier
application number: M003
MyMedic Arnica GelARNICA MONTANANantong Health & Beyond Hygienic Products Inc.0ef8760d-27c0-7ece-e063-6294a90a68732024-01-15WarningsExact identifier
application number: M003
American Safety First Aid AntispeticHYDROGEN PEROXIDEOrazen Incea2fbdfe-1932-9fb4-e053-2a95a90a35632024-01-15WarningsExact identifier
application number: M003
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
application number: M003
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
application number: M003
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
application number: M003
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipesALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDaf850b5e-c99f-3d4e-e053-2995a90a79482024-01-10WarningsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80 SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDba4b8fb3-09db-fa29-e053-2995a90a86172024-01-10WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNd4d77ec3-4930-74f0-e053-2a95a90a962a6
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDd4d77ec3-4930-74f0-e053-2a95a90a962a6
616456isopropyl alcohol 50 % Topical SolutionSYd4d77ec3-4930-74f0-e053-2a95a90a962a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51628-4233-151628423301355 mL in 1 BOTTLE, PLASTIC (51628-4233-1) 355 ml2020-06-180000-00-00NoNoCurrent
51628-4233-251628423302473 mL in 1 BOTTLE, PLASTIC (51628-4233-2) 473 ml2020-06-180000-00-00NoNoCurrent
51628-4233-351628423303946 mL in 1 BOTTLE, PLASTIC (51628-4233-3) 946 ml2020-06-180000-00-00NoNoCurrent