FDA.reportPublic FDA data

ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Product NDC
52000-802
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 88 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Pink SugarALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd322e5a64-dda1-c24e-e063-6394a90a82982025-02-01WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd3fce67c9-14e9-4e26-bb7f-9375a7f84a8a2025-01-31WarningsExact identifier
application number: M003
AntisepticALCOHOLWelly Health PCB85ce2c23-25d8-4b35-95ff-99f098d92bc92025-01-29WarningsExact identifier
application number: M003
Instant Hand SanitizerETHYL ALCOHOLRejoice International Corp.4e13511b-fbb3-2523-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Strawberry ScentedETHYL ALCOHOLNingbo Rejoice Internationala267a7a2-79b9-1da3-e053-2995a90a3a112025-01-28WarningsExact identifier
application number: M003
On Guard Sanitizing GelALCOHOLdoTERRA International, LLCe4b8b4bb-1d47-6826-e053-2a95a90ab1682025-01-28WarningsExact identifier
application number: M003
germstarLuxeETHYL ALCOHOLSoaptronic, LLC471b466f-e3e5-3601-e054-00144ff88e882025-01-28WarningsExact identifier
application number: M003
Refill 4ISOPROPYL ALCOHOLGFA Production (Xiamen) Co., Ltd.51348666-53e3-4cc7-99ba-cf3f23ddbcf62025-01-27WarningsExact identifier
application number: M003
Refill 3BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEGFA Production (Xiamen) Co., Ltd.0fc6a0df-2b1f-4415-8c7a-ee484b1d21fa2025-01-27WarningsExact identifier
application number: M003
Easy Care Hand SanitizerALCOHOLGFA Production (Xiamen) Co., Ltd.c7058806-ad4e-6d5f-e053-2a95a90a35e82025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk with aloe veraETHYL ALCOHOL 70%Rejoice International Corp.04fd3bbe-1729-a748-e063-6394a90a96552025-01-27WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lemonETHYL ALCOHOL 70%Rejoice International Corp.04fd9665-a6b3-678a-e063-6294a90a60a52025-01-27WarningsExact identifier
application number: M003
GERMSTARORIGINALISOPROPYL ALCOHOLSoaptronic, LLCda3ac935-7dc7-4100-a702-959eb84077b22025-01-24WarningsExact identifier
application number: M003
Germstar Premium Hand SanitizerETHYL ALCOHOLSoaptronic LLC489652af-7333-628a-e054-00144ff8d46c2025-01-24WarningsExact identifier
application number: M003
Little Buddy in a Little TubbyHAND SANITIZING TOWELETTESContinental Research Corpf4fac964-4a27-335d-e053-2a95a90ac4eb2025-01-23WarningsExact identifier
application number: M003
PHARMACYS PRESCRIPTION 8OZ HAND SANITIZERALCOHOLAmerican Consumer Products Corp7a048607-f4c3-6724-e053-2a91aa0ab6f22025-01-23WarningsExact identifier
application number: M003
SANITAXE 27 OZ INSTANT HAND SANITIZER WITH ALOE VERAALCOHOLAmerican Consumer Products Corpa8f00148-b8fa-6c4f-e053-2995a90ac5e22025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa9ca8aaa-ea76-7eb5-e053-2995a90adef92025-01-23WarningsExact identifier
application number: M003
Sanitaxe AntibacterialBENZALKONIUM CHLORIDEAmerican Consumer Products Corpa8c6ef84-b072-72ee-e053-2995a90aa1112025-01-23WarningsExact identifier
application number: M003
Hand sanitizer 2oz 2pk lavenderETHYL ALCOHOL 70%Rejoice International Corp.052031f9-5206-c1bc-e063-6394a90ab0f22025-01-23WarningsExact 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
52000-802-0252000080202178 mL in 1 BOTTLE, PLASTIC (52000-802-02) 178 ml2020-06-18NoNoCurrent
52000-802-0352000080203237 mL in 1 BOTTLE, PLASTIC (52000-802-03) 237 ml2020-06-18NoNoCurrent
52000-802-0452000080204295 mL in 1 BOTTLE, PLASTIC (52000-802-04) 295 ml2020-06-18NoNoCurrent
52000-802-0552000080205354 mL in 1 BOTTLE, PLASTIC (52000-802-05) 354 ml2020-06-18NoNoCurrent
52000-802-0652000080206414 mL in 1 BOTTLE, PLASTIC (52000-802-06) 414 ml2020-06-18NoNoCurrent
52000-802-0752000080207473 mL in 1 BOTTLE, PLASTIC (52000-802-07) 473 ml2020-06-18NoNoCurrent
52000-802-0852000080208946 mL in 1 BOTTLE, PLASTIC (52000-802-08) 946 ml2020-06-18NoNoCurrent