TERPENICOL

Product NDC
63347-600
11-digit product format
633470600
Labeler code
63347
Product ID
63347-600_92f83cae-7224-46f8-a9ac-550118c21f29
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Blaine Labs Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-04-01
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
TERPENICOL
Brand name suffix
ANTIFUNGAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998329Internal RxNorm lookup
2745978Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a020334e-aac9-4ea5-a0ea-8e5b021fe2ebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-600-01TERPENICOLANTIFUNGAL37.5 mL in 1 JARLIQUID37.56

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24NTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24NTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
CAPRYLIC ALCOHOLINACTIVE INGREDIENTNV1779205DTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
COCONUT ACIDINACTIVE INGREDIENT40U37V505DTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
GRAPE SEED OILINACTIVE INGREDIENT930MLC8XGGTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)INACTIVE INGREDIENT8136Y38GY5TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
LAURETH-4INACTIVE INGREDIENT6HQ855798JTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
OREGANO LEAF OILINACTIVE INGREDIENT7D0CGR40U1TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
PEG-7 GLYCERYL COCOATEINACTIVE INGREDIENTVNX7251543TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
UREAINACTIVE INGREDIENT8W8T17847WTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-600TERPENICOL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [BLAINE LABS INC.]6Current NDC, Legacy NDC, 1 package rows20231222_a020334e-aac9-4ea5-a0ea-8e5b021fe2eb.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 8 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSNa020334e-aac9-4ea5-a0ea-8e5b021fe2eb6
998329undecylenic acid 250 MG/ML Topical SolutionSCDa020334e-aac9-4ea5-a0ea-8e5b021fe2eb6
998329undecylenic acid 25 % Topical SolutionSYa020334e-aac9-4ea5-a0ea-8e5b021fe2eb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63347-600-016334706000137.5 mL in 1 JAR (63347-600-01) 37.5 ml2014-04-01NoNoCurrent