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 17 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Assorted Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de29d2-ebf1-7193-e063-6294a90ab3832026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.53de8eef-b344-3e25-e063-6394a90a01d82026-06-09WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitize Caramel LatteALCOHOLShenzhen Lantern Scicence Co.,Ltd.53df1a36-9b0a-4696-e063-6394a90a91a42026-06-09WarningsExact identifier
application number: M003
MISTIFY COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006e7bf-96f6-1faa-e063-6394a90ab5a32026-06-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsExact identifier
application number: M003
GNP Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLAmerisource Bergen03247512-7a31-4fb4-b7e0-efc337cab6932026-06-04WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsExact identifier
application number: M003
GNP Isopropyl Rubbing Alcohol 70 PercentISOPROPYL ALCOHOLAmerisource Bergen0ffd9643-3bc2-4b04-92c5-80fe5e429a252026-06-04WarningsExact identifier
application number: M003
PESI VANILLA HYDRATIING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53325d04-26db-fc62-e063-6394a90a322a2026-06-01WarningsExact identifier
application number: M003
KOOL AID PPINK LEMONADE HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53342b67-8742-1387-e063-6394a90acc742026-06-01WarningsExact identifier
application number: M003
ICEE CHERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53352f95-6477-25e3-e063-6394a90a9e022026-06-01WarningsExact identifier
application number: M003
JOLLY RANCHER BLUE RASPBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53357f28-a843-ec12-e063-6294a90a16fc2026-06-01WarningsExact identifier
application number: M003
SOURPATCHKIDS STRAWBERRY HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53358c4e-3021-1e85-e063-6294a90a07382026-06-01WarningsExact identifier
application number: M003
GUSHERS TROPICAL HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359191-0451-a1a0-e063-6394a90a81a12026-06-01WarningsExact identifier
application number: M003
MOUNTAIN DEW HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53359746-6033-c3d2-e063-6394a90a677c2026-06-01WarningsExact identifier
application number: M003
FLUFFY STUFF COTTON CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d246-5c4c-6773-e063-6294a90a8ffa2026-06-01WarningsExact identifier
application number: M003
DUBBLE BUBBLE ORIGINAL FLAVOR BUBBLE GUM HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5335d97d-3d8e-fc86-e063-6394a90abaad2026-06-01WarningsExact identifier
application number: M003
MISTIFY PUMPKIN HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e262fe-9a91-59c2-e063-6394a90ac32a2026-06-01WarningsExact identifier
application number: M003
MISTIFY CINNAMON HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e23fce-8560-087e-e063-6294a90a73bb2026-06-01WarningsExact identifier
application number: M003
MISTIFY SMORES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e2c4c4-0cdb-2d24-e063-6294a90a082f2026-06-01WarningsExact 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