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 85 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lemon 2ozALCOHOLNingbo Rejoice Internationalb08ea7ef-a595-6bef-e053-2a95a90a68fb2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer with Clip 1.8ozALCOHOLNingbo Rejoice Internationalb08f2909-467d-719d-e053-2995a90a11a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f2993-f166-1a0e-e053-2a95a90a93792025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f3bf1-f55f-5c68-e053-2a95a90ac3ac2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f6f48-796b-3b40-e053-2a95a90a75f62025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f62b0-98dd-5aac-e053-2a95a90a6d8a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer PouchALCOHOLNingbo Rejoice Internationalb08f8faa-d9d6-5b8d-e053-2a95a90a407c2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 24ct PouchALCOHOLNingbo Rejoice Internationalb08fb47c-7241-45d3-e053-2a95a90a8a942025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2ozALCOHOLNingbo Rejoice Internationalb08fd11a-48e2-67b6-e053-2995a90ac3992025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 8ozALCOHOLNingbo Rejoice Internationalb1914c86-4489-fbb8-e053-2995a90a5cd62025-02-13WarningsExact 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