FDA.reportPublic FDA data

Ethyl Alcohol

Product NDC
11344-876
11-digit product format
113440876
Labeler code
11344
Product ID
11344-876_5c145489-4898-9c7b-e063-6294a90acb59
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-07-15
Substance
ALCOHOL
Active strength
70 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
Ethyl Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-876-43Ethyl Alcohol473 mL in 1 BOTTLE, PLASTICLIQUID4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-876ETHYL ALCOHOL LIQUID [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250411_1bcec12b-d374-43dc-9acc-e5ea13fff53a.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 30 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerALCOHOLTrifecta Pharmaceuticals USA0ba469a8-53f3-eb8e-e063-6294a90a1efc2026-03-04WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percent ReadyInCaseISOPROPYL ALCOHOLP & L Development, LLCa6d2068f-705d-4341-b1c8-81e1b563ab9a2026-03-04WarningsExact identifier
application number: M003
50% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC95e31119-8487-4bc9-b1c2-c43d32fc80ce2026-03-03Warnings, Adverse reactionsExact identifier
application number: M003
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION3886a958-d035-ed15-e063-6294a90af1b52026-03-03WarningsExact identifier
application number: M003
Medicated Apricot ScrubSALICYLIC ACIDOld East Main Co.7c9c430b-30d8-4642-85bd-d028a9aa748a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEOld East Main Co.fb9bbb51-d131-42b4-94e6-b752595b10812026-03-02WarningsExact identifier
application number: M003
IsopropylISOPROPYL ALCOHOLOld East Main Co.ea6f3065-780e-4afc-a361-a2cb296ae4d52026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLOld East Main Co.2a09f6c0-e9a6-4f48-bce1-6cf7345f2d872026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLOld East Main Co.3e7a7f3e-3e99-4999-95c2-1603aca08e892026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLOld East Main Co.2b600254-2a70-4254-85fb-29b9adb56c9a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEOld East Main Co.3c823b47-2ab7-4002-9b6f-abf0a3176b442026-03-02Warnings, Adverse reactionsExact identifier
application number: M003
American Red Cross 6oz, 3% Hydrogen PeroxideAMERICAN RED CROSS 6 OZ, 3% HYDROGEN PEROXIDE SPRAYMY IMPORTS USA LLC29299c46-a929-0d92-e063-6294a90a42182026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLTARGET Corporationc49f46c5-f9b2-4045-a31d-63cb222102332026-03-02WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLSam's West, Inca9d6778a-e5ad-4e02-9142-4a932540eda72026-03-02WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEChain Drug Marketing Association31e7063e-0ba1-434f-b404-0ec42df634a32026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTUREThe Kroger Co.c70a718f-d51a-455a-9785-ab41c1b1f8b02026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
MedPride SterileBENZALKONIUM CHLORIDEShield Line LLC02f63d50-e4ff-49b6-9f8c-fddceefe65f32026-02-27WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalmart Inc.c8fa5ed3-0497-4a23-934b-c72ff02c94ae2026-02-27Warnings, Adverse reactionsExact identifier
application number: M003
FIGS - evolvetogether Hand Sanitizer FIGS 01 Ginger - Cedar ScentedETHYL ALCOHOLWE EVOLVETOGETHER INC.4bd5a36d-06b4-ba41-e063-6294a90aa1212026-02-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLUnited Natural Foods, Inc. dba UNFI4eee73dd-039e-44a5-b380-21ff32efee222026-02-26Warnings, Adverse reactionsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN1bcec12b-d374-43dc-9acc-e5ea13fff53a3
582753ethanol 0.7 ML/ML Topical SolutionSCD1bcec12b-d374-43dc-9acc-e5ea13fff53a3
582753ethanol 70 % Topical SolutionSY1bcec12b-d374-43dc-9acc-e5ea13fff53a3
582753ethyl alcohol 70 % Topical SolutionSY1bcec12b-d374-43dc-9acc-e5ea13fff53a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-876-4311344087643473 mL in 1 BOTTLE, PLASTIC (11344-876-43) 473 ml1989-07-15NoNoCurrent