FDA.reportPublic FDA data

Alcohol

Product NDC
68196-602
11-digit product format
681960602
Labeler code
68196
Product ID
68196-602_5117acf0-3ab6-705b-e063-6394a90a6deb
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Sam's West Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-01
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
Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
582753Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
16625ecb-11c3-a097-e063-6294a90af3d5Available 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
68196-602-68Alcohol2000 mL in 1 BOTTLE, PLASTICLIQUID20004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-602ALCOHOL (ETHYL ALCOHOL) LIQUID [SAM'S WEST INC]2Current NDC, 1 package rows20240724_16625ecb-11c3-a097-e063-6294a90af3d5.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlcoholETHYL ALCOHOLSam's West Inc16625ecb-11c3-a097-e063-6294a90af3d52026-05-05WarningsExact identifier
ndc (product): 68196-602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN16625ecb-11c3-a097-e063-6294a90af3d54
582753ethanol 0.7 ML/ML Topical SolutionSCD16625ecb-11c3-a097-e063-6294a90af3d54
582753ethanol 70 % Topical SolutionSY16625ecb-11c3-a097-e063-6294a90af3d54
582753ethyl alcohol 70 % Topical SolutionSY16625ecb-11c3-a097-e063-6294a90af3d54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-602-68681960602682000 mL in 1 BOTTLE, PLASTIC (68196-602-68) 2000 ml2024-07-01NoNoCurrent