FDA.reportPublic FDA data

Isopropyl alcohol

Product NDC
49580-0272
11-digit product format
495800272
Labeler code
49580
Product ID
49580-0272_fa37487f-1742-4acf-9617-7535b119a6e5
Type
HUMAN OTC DRUG
Nonproprietary name
Isopropyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
P & L Development, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-30
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 alcohol
Brand name suffix
50 percent Wintergreen ReadyInCase
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
f9ff67b0-c4ad-4162-b3ef-27a85ed0da25Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0272-2Isopropyl alcohol50 percent Wintergreen ReadyInCase355 mL in 1 BOTTLE, PLASTICLIQUID35510
49580-0272-3Isopropyl alcohol50 percent Wintergreen ReadyInCase946 mL in 1 BOTTLE, PLASTICLIQUID94610
49580-0272-6Isopropyl alcohol50 percent Wintergreen ReadyInCase473 mL in 1 BOTTLE, PLASTICLIQUID47310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M416302ISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2
ISOPROPYL ALCOHOLACTIVE MOIETYND2M416302ISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [AARON INDUSTRIES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0272ISOPROPYL ALCOHOL 50 PERCENT WINTERGREEN READYINCASE (ISOPROPYL ALCOHOL) LIQUID [P & L DEVELOPMENT, LLC]10Current NDC, Legacy NDC, 3 package rows20250221_f9ff67b0-c4ad-4162-b3ef-27a85ed0da25.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 87 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand sanitizer 16.9oz with vitamin EETHYL ALCOHOL 70%REJOICE INTERNATIONAL CORP.03f869b3-3004-8b25-e063-6294a90a176e2025-02-06WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COTTON VANILLIAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d613ab9-c87b-1f3c-e063-6394a90a31202025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER COCONUTALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6148e2-d959-6150-e063-6294a90acba52025-02-05WarningsExact identifier
application number: M003
ORBIT INNOVATIONS HAND SANITIZER WATERMELONALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd2d6175c9-abe5-4c68-e063-6394a90afc362025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.eb5d6739-ee36-cd74-e053-2a95a90ab6592025-02-05WarningsExact identifier
application number: M003
Hand sanitizer 29ml 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.037b4acb-49ca-bc0a-e063-6394a90a1fcc2025-02-05WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.ecef31dc-2f36-b578-e053-2995a90a3acd2025-02-05WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
application number: M003
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
application number: M003
HAND SANITIZER VANILLAALCOHOL ANTISEPTIC GELKingkey MBC Life Technology Group Co.,Ltd32055326-c229-5f10-e063-6394a90ab62c2025-02-01WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616456isopropyl alcohol 50 % Topical SolutionPSNf9ff67b0-c4ad-4162-b3ef-27a85ed0da2510
616456isopropyl alcohol 0.5 ML/ML Topical SolutionSCDf9ff67b0-c4ad-4162-b3ef-27a85ed0da2510
616456isopropyl alcohol 50 % Topical SolutionSYf9ff67b0-c4ad-4162-b3ef-27a85ed0da2510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0272-249580027202355 mL in 1 BOTTLE, PLASTIC (49580-0272-2) 355 ml2014-06-300000-00-00NoNoCurrent
49580-0272-349580027203946 mL in 1 BOTTLE, PLASTIC (49580-0272-3) 946 ml2014-06-300000-00-00NoNoCurrent
49580-0272-649580027206473 mL in 1 BOTTLE, PLASTIC (49580-0272-6) 473 ml2014-06-300000-00-00NoNoCurrent