AZOLEN
- Product NDC
- 58980-819
- 11-digit product format
- 589800819
- Labeler code
- 58980
- Product ID
- 58980-819_85b974c1-bef2-4320-93a4-0fcf7774c55c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MICONAZOLE NITRATE
- Dosage form
- LIQUID
- Route
- TOPICAL
- Labeler
- STRATUS PHARMACEUTICALS INC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-14
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AZOLEN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 2 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3264bd0a-c628-404b-8c09-8586682d054e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58980-819-60 | AZOLEN | 170 g in 1 BOTTLE | LIQUID | 170 | 2 | |
| 58980-819-60 | AZOLEN | 1 in 1 BOX | LIQUID | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| Gemachlich Zu Hause Vaginal Antifungal Gel | MICONAZOLE NITRATE | Guangzhou Xinhongda Trading Service Co., Ltd. | 563cfb57-f10c-96a6-e063-6294a90a2b93 | 2026-08-06 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | Sun Pharmaceutical Industries, Inc. | 7fd4037e-d350-47b7-a7d9-a43b8e366fa0 | 2026-08-05 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Family Dollar Services, Inc | 57c20748-fdad-b73b-e063-6294a90a1c17 | 2026-08-04 | Warnings | M005 |
| Gembooxt RINGWORM Cream | MICONAZOLE NITRATE, HYDROCORTISONE | Guangdong Quadrant Ecological Technology Co., Ltd. | 464a33c3-6d16-0cfd-e063-6294a90abf4b | 2026-08-04 | Warnings | M005 |
| YAMANGU FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5843cc12-de66-ca47-e063-6294a90ae55b | 2026-08-04 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Meijer Distribution Inc | 0b3eb169-b309-8c1a-e063-6294a90a726e | 2026-08-03 | Warnings | M005 |
| ProCure Antifungal Cream | MICONAZOLE NITRATE 2% | Twin Med LLC | 39d55df5-8a8e-3a9b-e063-6294a90af20b | 2026-08-03 | Warnings | M005 |
| MiratiFul Nail Fungus Treatment | TOLNAFTATE | Texas MiratiFul Enterprises Inc. | 35eb20e3-86d4-4bec-b572-3d5fe86ac74d | 2026-08-03 | Warnings | M005 |
| LUCKSKY Fungal Nail Renewal | UNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57a73b60-bbac-97e6-e063-6294a90ab9a9 | 2026-07-28 | Warnings | M005 |
| Ponamfo ANTIFUNGAL TREATMENT PEN | UNDECYLENIC | Guangzhou Bixiaoyu Trading Co., Ltd. | 57a9ccff-270b-9769-e063-6394a90a5e0c | 2026-07-28 | Warnings | M005 |
| FUNGAL NAIL PATCHES | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 5240412c-4257-8e9d-e063-6394a90a0a12 | 2026-07-28 | Warnings | M005 |
| FFPMAM Antifungal Cream | FFPMAM ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 57b7cf61-d4cd-53f7-e063-6394a90afc54 | 2026-07-28 | Warnings | M005 |
| Youggle WART REMOVER | SALICYLIC ACID | Guangzhou Huixue Biotechnology Co., Ltd. | 57a3744e-316c-8a3d-e063-6294a90a15d1 | 2026-07-27 | Warnings | M005 |
| antifungal pen | ANTIFUNGAL PEN | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 5756256e-ed2b-4e13-e063-6294a90a1e0f | 2026-07-24 | Warnings | M005 |
| SERYNTH ANTIFUNGAL NAIL TREATMENT PEN | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d59116a-bcd0-9ed4-e063-6394a90a6dbd | 2026-07-24 | Warnings | M005 |
| SERYNTH MULTI-PURPOSE FUNCUS | TOLNAFTATE 1% MULTI-PURPOSE FUNCUS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a6ea0c9-1495-8ede-e063-6294a90ad093 | 2026-07-23 | Warnings | M005 |
| HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shanghai Honghui Chuang Intelligent Technology Co., Ltd | 55753a4a-a4d0-a183-e063-6394a90acf11 | 2026-07-22 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit .liquid. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 5719942d-6b10-612e-e063-6294a90a4fe9 | 2026-07-21 | Warnings | M005 |
| BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil | UNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OIL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ff57d2d-5e74-a995-e063-6394a90a3f9a | 2026-07-21 | Warnings | M005 |
| WERPEKA FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4f7a8273-b7af-d532-e063-6394a90aa63a | 2026-07-21 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58980-819-60 | 58980081960 | 1 BOTTLE in 1 BOX (58980-819-60) / 170 g in 1 BOTTLE | 1 bottle | 2023-09-14 | No | No | Current |