FDA.reportPublic FDA data

Fortinia ID

Product NDC
54633-216
11-digit product format
546330216
Labeler code
54633
Product ID
54633-216_47e36787-66d5-d17e-e063-6394a90a0d73
Type
HUMAN OTC DRUG
Nonproprietary name
phenol
Dosage form
LIQUID
Route
TOPICAL
Labeler
The Podiatree Company
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-03
Substance
PHENOL
Active strength
1.5 g/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
Fortinia ID
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL1.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199858Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
60c88eb7-22fe-4881-e053-2a91aa0a70ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54633-216-15Fortinia ID14.8 mL in 1 BOTTLELIQUID14.83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54633-216FORTINIA ID (PHENOL) LIQUID [THE PODIATREE COMPANY]2Current NDC, Legacy NDC, 1 package rows20171220_60c88eb7-22fe-4881-e053-2a91aa0a70ce.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 22 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lucys Renewals Skin and Nails First Aid AntisepticBENZETHONIUM CHLORIDEACP Laboratories LLCa702297d-8f7e-4019-a987-7bd83becb5ee2026-05-07WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Sea BreezeALCOHOLScent Theory Products LLC3cfac192-84c8-7897-e063-6294a90ae93d2026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Whipped CoconutALCOHOLScent Theory Products LLC3cfaadb3-1881-2dd9-e063-6394a90abcb42026-05-06WarningsExact identifier
application number: M003
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC3cf7a910-28c8-bbe2-e063-6394a90aff732026-05-06WarningsExact identifier
application number: M003
Minee Wipes Antibacterial Hand WipeBENZALKONIUM CHLORIDEAmbition Power Brands5132bc70-bf3b-180c-e063-6394a90afdad2026-05-06WarningsExact identifier
application number: M003
Kleenex Reveal Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark4a491f90-268e-470d-a74c-473f1efe7c8b2026-05-06WarningsExact identifier
application number: M003
Boo Crew Hand Care Essentials Boo Berry, Pumpkin SpiceALCOHOLScent Theory Products LLC51143d5c-4cd0-0b2e-e063-6294a90a28312026-05-05WarningsExact identifier
application number: M003
Scott Moisturizing Foam Hand SanitizerALCOHOLKimberly-Clark25900e62-c8fd-4942-ad38-4b99243084602026-05-05WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDENantong Health & Beyond Hygienic Products Inc.cb97ba55-d678-4e43-aa85-37e9f530e9112026-05-04WarningsExact identifier
application number: M003
EVERLIT CARE PRODUCTS ANTISEPTIC MISTHYDROGEN PEROXIDEEVERLIT GLOBAL INC.4873b106-4ea2-412c-a7ab-756a111959842026-05-04WarningsExact identifier
application number: M003
Limited Edition Hand Sanitizer Golden Vanilla, Starlight Frost, Pink Satin ProseccoALCOHOLScent Theory Products LLC50f03829-eda8-3a25-e063-6294a90a6fd22026-05-03WarningsExact identifier
application number: M003
DUBBLE BUBBLE HAND SANITIZER BUBBLE GUMALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52084e0a-ffe2-83f4-e063-6294a90a305e2026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANI BIRTHDAY CAKEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520828a5-4e8d-b637-e063-6394a90ab4912026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI BLUE RASBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b5-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER COTTON CANDYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208adea-27da-81a3-e063-6294a90afc802026-05-01WarningsExact identifier
application number: M003
ICEE HAND SANI CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52089622-d9b6-b5cb-e063-6394a90ad4262026-05-01WarningsExact identifier
application number: M003
KOOL AID HAND SANITIZER BUBBLE PINK LEMONADEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5208bd2c-277c-648e-e063-6294a90a5b282026-05-01WarningsExact identifier
application number: M003
DIPPIN DOTS HAND SANITIZER RAINBOW ICEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd52092127-7a8d-5db3-e063-6294a90a07b52026-05-01WarningsExact identifier
application number: M003
Liquid death hand sanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd520943a4-0e63-a9ab-e063-6394a90ab2a92026-05-01WarningsExact identifier
application number: M003
Redicare Antiseptic TowelettesANTISEPTIC TOWELETTESRedicare LLC484c8ff5-cc11-b646-e063-6394a90a5f502026-05-01WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199858phenol 1.5 % Topical SolutionPSN60c88eb7-22fe-4881-e053-2a91aa0a70ce3
199858phenol 15 MG/ML Topical SolutionSCD60c88eb7-22fe-4881-e053-2a91aa0a70ce3
199858phenol 1.5 % Topical SolutionSY60c88eb7-22fe-4881-e053-2a91aa0a70ce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54633-216-155463302161514.8 mL in 1 BOTTLE (54633-216-15) 14.8 ml2017-01-030000-00-00NoNoCurrent