FDA.reportPublic FDA data

HiGHMARK

Product NDC
63148-402
11-digit product format
631480402
Labeler code
63148
Product ID
63148-402_51524774-ebaa-c3a5-e063-6294a90acdc6
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Apollo Health and Beauty Care
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
ALCOHOL
Active strength
70 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
HiGHMARK
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
f9643d82-ae87-ea72-e053-6394a90ad82fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-402-08HiGHMARK236 mL in 1 BOTTLE, PLASTICLIQUID2366
63148-402-32HiGHMARK946 mL in 1 BOTTLE, PLASTICLIQUID9466

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-402HIGHMARK (ALCOHOL) LIQUID [APOLLO HEALTH AND BEAUTY CARE]3Current NDC, 2 package rows20241022_f9643d82-ae87-ea72-e053-6394a90ad82f.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
HiGHMARKALCOHOLApollo Health and Beauty Caref9643d82-ae87-ea72-e053-6394a90ad82f2026-05-08WarningsExact identifier
ndc (product): 63148-402

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSNf9643d82-ae87-ea72-e053-6394a90ad82f6
582753ethanol 0.7 ML/ML Topical SolutionSCDf9643d82-ae87-ea72-e053-6394a90ad82f6
582753ethanol 70 % Topical SolutionSYf9643d82-ae87-ea72-e053-6394a90ad82f6
582753ethyl alcohol 70 % Topical SolutionSYf9643d82-ae87-ea72-e053-6394a90ad82f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63148-402-0863148040208236 mL in 1 BOTTLE, PLASTIC (63148-402-08) 236 ml2023-06-01NoNoCurrent
63148-402-3263148040232946 mL in 1 BOTTLE, PLASTIC (63148-402-32) 946 ml2023-06-01NoNoCurrent