FDA.reportPublic FDA data

Guard

Product NDC
63148-502
11-digit product format
631480502
Labeler code
63148
Product ID
63148-502_51162d81-5f65-c711-e063-6394a90aa33d
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
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
Guard
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
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fdc99948-1bd0-cdf2-e053-6394a90aaf97Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-502-08Guard227 mL in 1 BOTTLE, PLASTICGEL2275

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-502GUARD (ALCOHOL) GEL [APOLLO HEALTH AND BEAUTY CARE]3Current NDC, 1 package rows20250106_fdc99948-1bd0-cdf2-e053-6394a90aaf97.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
GuardALCOHOLApollo Health and Beauty Carefdc99948-1bd0-cdf2-e053-6394a90aaf972026-05-05WarningsExact identifier
ndc (product): 63148-502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNfdc99948-1bd0-cdf2-e053-6394a90aaf975
581662ethanol 0.7 ML/ML Topical GelSCDfdc99948-1bd0-cdf2-e053-6394a90aaf975
581662ethanol 70 % Topical GelSYfdc99948-1bd0-cdf2-e053-6394a90aaf975
581662ethyl alcohol 70 % Topical GelSYfdc99948-1bd0-cdf2-e053-6394a90aaf975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63148-502-0863148050208227 mL in 1 BOTTLE, PLASTIC (63148-502-08) 227 ml2023-06-01NoNoCurrent