FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Product NDC
52000-802
Requested package NDC
52000-802-01
11-digit product format
520000802
Labeler code
52000
Product ID
52000-802_2f984580-5e4d-ace5-e063-6294a90a71a5
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Universal Distribution Center 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
2f9846ce-37ca-a95b-e063-6294a90ad260Available 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
52000-802-01ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN119 mL in 1 BOTTLE, PLASTICLIQUID1191
52000-802-02ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN178 mL in 1 BOTTLE, PLASTICLIQUID1781
52000-802-03ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN237 mL in 1 BOTTLE, PLASTICLIQUID2371
52000-802-04ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN295 mL in 1 BOTTLE, PLASTICLIQUID2951
52000-802-05ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN354 mL in 1 BOTTLE, PLASTICLIQUID3541
52000-802-06ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN414 mL in 1 BOTTLE, PLASTICLIQUID4141
52000-802-07ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN473 mL in 1 BOTTLE, PLASTICLIQUID4731
52000-802-08ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN946 mL in 1 BOTTLE, PLASTICLIQUID9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-802ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN (ISOPROPYL ALCOHOL) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]1Current NDC, 8 package rows20250308_2f9846ce-37ca-a95b-e063-6294a90ad260.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 79 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear DefenseHAND SANITIZING WIPESMelaleuca, Inc.30dec472-8112-37d6-e063-6294a90a1f252025-04-24WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
application number: M003
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
application number: M003
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsExact identifier
application number: M003
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsExact identifier
application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18720bd0-6ea8-2d1b-e063-6394a90abe2d2025-04-23WarningsExact identifier
application number: M003
E-2 HAND ITEM 1095CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18728ebb-c416-5efe-e063-6294a90abd912025-04-23WarningsExact identifier
application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871b1db-f881-e7fd-e063-6294a90ada982025-04-23WarningsExact identifier
application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1870b08e-e5c3-7888-e063-6394a90a1c822025-04-23WarningsExact identifier
application number: M003
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSN2f9846ce-37ca-a95b-e063-6294a90ad2601
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCD2f9846ce-37ca-a95b-e063-6294a90ad2601
616456isopropyl alcohol 50 % Topical SolutionSY2f9846ce-37ca-a95b-e063-6294a90ad2601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-802-0152000080201119 mL in 1 BOTTLE, PLASTIC (52000-802-01) 119 ml2020-06-18NoNoCurrent