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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact 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