Undecylenic Acid
- Product NDC
- 70947-025
- 11-digit product format
- 709470025
- Labeler code
- 70947
- Product ID
- 70947-025_eff70205-270d-be0c-e053-2a95a90a5b9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Undecylenic Acid
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- Worldwide Cosmetics, Inc
- Application
- M005
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2016-10-01
- Marketing end
- 0000-00-00
- Substance
- UNDECYLENIC ACID
- Active strength
- 25 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70947-025 | I | Inactivated by FDA | 2026-10-15 | ||
| excluded package | package | 70947-025 | 70947-025-15 | I | Inactivated by FDA | 2026-10-15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70947-025-15 | 2022-06-28 | C162847 | 48780-1 | 9d75b9d0-6ddb-f424-e053-dadaa90a57ce | 70947-025-15 |
| 70947-025-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6ddb-f424-e053-dadaa90a57ce | 70947-025-15 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70947-025-15 | ETERNAL SPIRIT BEAUTY FUNGI FRESH | 15 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 15 | 5 |
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 |
|---|---|---|---|---|---|---|
| Tolnaftate | TOLNAFTATE | Sheffield Pharmaceuticals LLC | ca52af37-c3a2-414c-a24a-a37a92925133 | 2025-02-20 | Warnings | M005 |
| Dr Sheffield Athletes Foot | CLOTRIMAZOLE | Sheffield Pharmaceuticals LLC | b8b8e6b2-1022-4592-91ba-3cf94c7cf318 | 2025-02-19 | Warnings | M005 |
| UKVOA Toenail Fungus Treatment | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2e3cde7b-850e-f9d2-e063-6394a90adb18 | 2025-02-16 | Warnings | M005 |
| UKOVA FOOT ODOR PROBIOTIC | TOLNAFTATE 1% FUNGI NAIL | Jiashen International Trade Limited | 2de0225d-dd85-e2da-e063-6294a90a050b | 2025-02-11 | Warnings | M005 |
| Dr. Scholls Instant Cool Athletes Foot Wipes | TOLNAFTATE | Cosco International, Inc. | cde656a9-7841-4a73-a2f4-f5a76a3e15c1 | 2025-02-06 | Warnings | M005 |
| Silka Athletes Foot | MICONAZOLE NITRATE | Genomma Lab USA | 307104a2-2df6-43b0-bf3f-f4d93d3e40f1 | 2025-02-05 | Warnings | M005 |
| MICONAZOLE Nitrate | MICONAZOLE NITRATE | NuCare Pharmaceuticals,Inc. | fd7dd2eb-03a7-ef1f-e053-6294a90a8557 | 2025-02-04 | Warnings | M005 |
| Molecular AF | TOLNAFTATE | Renu Laboratories, LLC | 1b47e687-29cf-48ce-8bc3-ac8f44f05baa | 2025-02-03 | Warnings | M005 |
| Dermatool Fungal Nail Treatment | TOLNAFTATE 1% | Papalo Group LLC | 2d2c0e12-123d-75bd-e063-6394a90ae546 | 2025-01-31 | Warnings | M005 |
| 70% Isopropyl Alcohol | ISOPROPYL ALCOHOL | IDO PHARM | d5833c6f-81dd-6ff6-e053-2995a90ac76d | 2025-01-30 | Warnings | M005 |
| AWAS ALCOHOLSPRAY | ALCOHOL | IDO PHARM | 03010837-0289-3e08-e063-6394a90a7d04 | 2025-01-30 | Warnings | M005 |
| ELON Dual Defense Anti Fungal Formula | UNDECYLENIC ACID | Little Giant Holdings LLC | 45c4567d-7876-6459-e054-00144ff88e88 | 2025-01-28 | Warnings | M005 |
| DCH Labs Antifungal Jock | MICONAZOLE NITRATE 2% | Derma Care Research Labs, LLC | fc749882-2e1e-cad3-e053-6294a90a33ca | 2025-01-27 | Warnings | M005 |
| Antifungal Pen | UNDECYLENIC ACID 25% | XF Agencija Limited | a15d4512-0fc6-424f-9dd3-ab433d9b7a26 | 2025-01-27 | Warnings | M005 |
| Mata Hongos | UNDECYLENIC ACID | Vitamex USA, Corp | 21ca7edb-dde3-5846-e063-6394a90a3cc0 | 2025-01-23 | Warnings | M005 |
| Povidone Iodine Scrub | POVIDONE-IODINE | Jianerkang Medical Co., Ltd | 53cb4c0d-40b5-4cf3-b122-fd6dd654883f | 2025-01-23 | Warnings | M005 |
| NATUREPLEX TOLNAFTATE ANTIFUNGAL | TOLNAFTATE | Natureplex, LLC | 575b8645-9166-4242-a74f-f4aa4acaaf3d | 2025-01-15 | Warnings | M005 |
| Tobcharm Antifungal Treatment Cream | ANTIFUNGAL TREATMENT CREAM | Guangzhou Zanming Trading Co., Ltd. | 2ba241cc-2767-1190-e063-6294a90ac66b | 2025-01-13 | Warnings | M005 |
| MICONAZOLE Nitrate 2% | MICONAZOLE NITRATE | Akron Pharma Inc. | 8933f939-098a-4257-8d9c-4d5c3240e9a6 | 2025-01-10 | Warnings | M005 |
| ANTI-ITCH FEMININE CARE | HYDROCORTISONE 0.5% | OL PHARMA TECH, LLC Drs PHARMACY | d6fa5ff3-ebdc-222d-e053-2a95a90a88d5 | 2025-01-09 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998329 | undecylenic acid 25 % Topical Solution | PSN | 3cf281eb-616e-4a17-e054-00144ff88e88 | 5 |
| 998329 | undecylenic acid 250 MG/ML Topical Solution | SCD | 3cf281eb-616e-4a17-e054-00144ff88e88 | 5 |
| 998329 | undecylenic acid 25 % Topical Solution | SY | 3cf281eb-616e-4a17-e054-00144ff88e88 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70947-025-15 | 70947002515 | 15 mL in 1 BOTTLE, WITH APPLICATOR (70947-025-15) | 15 ml | 2016-10-01 | 0000-00-00 | No | No | Current |