FDA.reportPublic FDA data

Alcohol

Product NDC
0363-0046
Requested package NDC
0363-0046-16
11-digit product format
003630046
Labeler code
0363
Product ID
0363-0046_4aa55b68-0251-e9b8-e063-6394a90aebae
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Walgreen Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-17
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alcohol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL62 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
247835Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e879904-055e-4bec-a504-3c783fc9fb24Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0046-16Alcohol59 mL in 1 BOTTLE, PLASTICLIQUID5914

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0046ALCOHOL LIQUID [WALGREENS]12Current NDC, Legacy NDC, 1 package rows20240608_1e879904-055e-4bec-a504-3c783fc9fb24.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
AlcoholALCOHOLWalgreen Co.1e879904-055e-4bec-a504-3c783fc9fb242026-02-12Warnings, Adverse reactionsExact identifier
ndc (package): 0363-0046-16
ndc (product): 0363-0046
ndc11 (package): 00363004616

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
247835ethanol 62 % Topical SolutionPSN1e879904-055e-4bec-a504-3c783fc9fb2414
247835ethanol 0.62 ML/ML Topical SolutionSCD1e879904-055e-4bec-a504-3c783fc9fb2414
247835ethanol 62 % Topical SolutionSY1e879904-055e-4bec-a504-3c783fc9fb2414
247835ethyl alcohol 62 % Topical SolutionSY1e879904-055e-4bec-a504-3c783fc9fb2414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0046-160036300461659 mL in 1 BOTTLE, PLASTIC (0363-0046-16) 59 ml2020-08-170000-00-00NoNoCurrent