TERPENICOL

Product NDC
63347-601
11-digit product format
633470601
Labeler code
63347
Product ID
63347-601_f6a16024-2fa1-44ff-a718-af2dc7ae822e
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Blaine Labs Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-19
Substance
UNDECYLENIC ACID
Active strength
4.55 g/37.5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TERPENICOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID4.55 g/37.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-601-012022-02-21C16284748780-1d6a99b39-9c5e-a426-e053-dadaa90af4c2Terpenicol - 601
63347-601-012022-01-28C16284748780-1d6a99b39-9c5e-a426-e053-dadaa90af4c2Terpenicol - 601

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-601-01TERPENICOL37.5 mL in 1 BOTTLECREAM37.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-601TERPENICOL (UNDECYLENIC ACID) CREAM [BLAINE LABS INC.]3Current NDC, Legacy NDC, 1 package rows20231222_efd99ed1-07d3-4862-ae47-883f7d1c91c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63347-601-016334706010137.5 mL in 1 BOTTLE (63347-601-01) 37.5 ml2017-06-190000-00-00NoNoCurrent