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 9 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIobow FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a49db2b-e45a-57c5-e063-6294a90a065c2026-06-23WarningsExact identifier
application number: M005
RoyceDerm Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC54d3ae29-8919-4868-e063-6294a90a587e2026-06-22WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT LIQUIDWalgreens Company94f4f656-e8a3-4439-b53c-12be59dc8eac2026-06-20WarningsExact identifier
application number: M005
VTROUY Fungal Nail Renewal PenFUNGAL NAIL RENEWAL PENGuangzhou Jingliang Cosmetics Co., Ltd.549bf490-99c2-c800-e063-6394a90a672b2026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea TreeTOLNAFTATERida LLC0c7a3b2d-8b1c-4130-86ad-892a591574802026-06-19WarningsExact identifier
application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsExact identifier
application number: M005
Anytalk FUNGAL NAIL TREATMENTTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.54718558-376f-ed31-e063-6294a90a52202026-06-17WarningsExact identifier
application number: M005
KLIPP FUNGAL NAIL TREATMENTKLIPP FUNGAL NAIL TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd547f2fbe-a2de-057d-e063-6394a90ac7422026-06-17WarningsExact identifier
application number: M005
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
application number: M005
WKPIKI FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.54472c44-93de-d4b9-e063-6394a90adde12026-06-15WarningsExact identifier
application number: M005
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SolutionBIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTIONGuangxi Rise Biological Technology Co.,Ltd.5457a623-7812-e516-e063-6394a90a8bfd2026-06-15WarningsExact identifier
application number: M005
TOYKNIER MULTI-PURPOSE TREATMENTUNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4f8eb3a3-8f26-50dd-e063-6294a90ad9f82026-06-14WarningsExact identifier
application number: M005
CYYZROSE ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD527765d4-6988-ed4e-e063-6394a90a2f232026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a2317d2-e45b-1fe2-e063-6394a90a940d2026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a23c01b-492d-324b-e063-6394a90a73b12026-06-14WarningsExact identifier
application number: M005
HEALMUSZ Multi-PurposeTreatmentTOLNAFTATE 1% MULTI-PURPOSETREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a2421d8-a543-abb1-e063-6394a90afaa72026-06-14WarningsExact identifier
application number: M005
HEALMUSZ FOOT ODOR PROBIOTICTOLNAFTATE 1% FOOT ODOR PROBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a24b5ae-f86c-459f-e063-6394a90ac5c32026-06-14WarningsExact identifier
application number: M005
PUVIDA Helps WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4828d7-091b-7c8e-e063-6294a90af1362026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4a484e3d-d653-2689-e063-6394a90a64ef2026-06-14WarningsExact 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