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
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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| UNDECYLENIC ACID | 4.55 g/37.5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| K3D86KJ24N | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| efd99ed1-07d3-4862-ae47-883f7d1c91c6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63347-601-01 | 2022-02-21 | C162847 | 48780-1 | d6a99b39-9c5e-a426-e053-dadaa90af4c2 | Terpenicol - 601 |
| 63347-601-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9c5e-a426-e053-dadaa90af4c2 | Terpenicol - 601 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63347-601-01 | TERPENICOL | 37.5 mL in 1 BOTTLE | CREAM | 37.5 | 3 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PHARMBANNER TINEA VERSICOLOR Cream | TINEA VERSICOLOR CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3db832f4-630d-72a2-e063-6394a90a08dc | 2026-02-12 | Warnings | M005 |
| Tolnafate | TOLNAFTATE JOCK ITCH POWDER SPRAY - TALC FREE | Chain Drug Consortium, LLC | 5f9edcf9-b99e-65a2-e053-2a91aa0af565 | 2026-02-12 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Chain Drug Consortium, LLC | 5fafc16d-7257-fc88-e053-2991aa0a67c4 | 2026-02-12 | Warnings | M005 |
| Kerova Miconazole Nitrate | MICONAZOLE NITRATE | Guangzhou Bixiaoyu Trading Co., Ltd. | 3b8b5547-f8d1-9e48-e063-6294a90af429 | 2026-02-12 | Warnings | M005 |
| natouch | MICONAZOLE | Natouch LLC | a980ff33-2b6d-3065-e053-2995a90ae974 | 2026-02-11 | Warnings | M005 |
| Tuymec Antifungal Medicated Bar | ANTIFUNGAL MEDICATED BAR | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a8265c5-9c69-a36a-e063-6294a90ab292 | 2026-02-11 | Warnings | M005 |
| Tuymec FUNGAL NAIL TREATMENT Kit | FUNGAL NAIL TREATMENT KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a983b42-9723-7a3a-e063-6394a90ae7b2 | 2026-02-11 | Warnings | M005 |
| Miconazole Nitrate | ATHLETES FOOT SPRAY | CVS Pharmacy | 1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c | 2026-02-10 | Warnings | M005 |
| Kerova ANTIFUNGAL | CLOTRIMAZOLE | Guangzhou Bixiaoyu Trading Co., Ltd. | 4a7b48cf-72c3-be63-e063-6394a90a1efe | 2026-02-10 | Warnings | M005 |
| Kerova Clotrimazole | ANTIFUNGAL | Guangzhou Bixiaoyu Trading Co., Ltd. | 4a7b9658-f411-299d-e063-6394a90af9ce | 2026-02-10 | Warnings | M005 |
| natouch | MICONAZOLE | Natouch LLC | 3b1209fc-9d6b-2f55-e063-6394a90ac2ad | 2026-02-10 | Warnings | M005 |
| Nabrace Wipes for Ringworm, Jockitch and Athlete Feet | NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET | Nabrace LLC | 0fdd1658-5759-8a42-e063-6394a90a7271 | 2026-02-10 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Antigungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH ANTIGUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4a633da8-dcba-349c-e063-6294a90a7702 | 2026-02-09 | Warnings | M005 |
| Fungus Master Antifungal Treatment | MICONAZOLE NITRATE | Ebanel Laboratories, Inc | f7b011b2-11e5-46f1-afed-89f438985e00 | 2026-02-09 | Warnings | M005 |
| OSIMOON Toenail Fungus Treatment | TOENAIL FUNGUS TREATMENT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4a7061a9-8ba2-72b8-e063-6294a90a4d9a | 2026-02-09 | Warnings | M005 |
| CLOTRIMAZOLE 1% | CLOTRIMAZOLE | PHARMACY CHOICE INC | 43852cfb-6d28-e54f-e063-6394a90aa090 | 2026-02-08 | Warnings | M005 |
| ASSIELF ANTIFUNGAL PEN | UNDECYLENIC ACID | Shenzhen Yuanbang International Logistics Co., Ltd | 4a5d8e86-6401-7556-e063-6394a90acce1 | 2026-02-08 | Warnings | M005 |
| Dryello Dual Action Relief for Athlete Foot | TOLNAFTATE | ProPedix, Inc. | 359478dd-02c9-05e5-e063-6294a90a41ed | 2026-02-06 | Warnings | M005 |
| HEALMUSZ Clotrimazole | CLOTRIMAZOLE1% MICONAZOLE1% CLOTRIMAZOLE | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a326159-a6a7-c1d6-e063-6294a90a3b89 | 2026-02-06 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Wal-Mart Stores, Inc. | 17d0486e-e8b5-3afe-e063-6394a90aa384 | 2026-02-04 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63347-601-01 | 63347060101 | 37.5 mL in 1 BOTTLE (63347-601-01) | 37.5 ml | 2017-06-19 | 0000-00-00 | No | No | Current |