FifthPulse Miconazole Nitrate Antifungal
- Product NDC
- 87525-004
- 11-digit product format
- 875250004
- Labeler code
- 87525
- Product ID
- 87525-004_4e7d2ee6-0c87-7391-e063-6394a90a4ee8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MICONAZOLE NITRATE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- WeCare Products LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-30
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- FifthPulse Miconazole Nitrate Antifungal
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 20 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b70238eb-afcb-4e09-976f-973df249241c | 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 |
|---|---|---|---|---|---|---|
| 87525-004-01 | FifthPulse Miconazole Nitrate Antifungal | 1 in 1 BOX | OINTMENT | 1 | 1 | |
| 87525-004-01 | FifthPulse Miconazole Nitrate Antifungal | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 1 | |
| 87525-004-02 | FifthPulse Miconazole Nitrate Antifungal | 1 in 1 BOX | OINTMENT | 1 | 1 | |
| 87525-004-02 | FifthPulse Miconazole Nitrate Antifungal | 113.4 g in 1 TUBE | OINTMENT | 113.4 | 1 |
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 |
|---|---|---|---|---|---|---|
| ProClearz Maximum Strength Fungal Shield Brush-on Antifungal | TOLNAFTATE | Rooftop Consumer Health, Inc. | 4d451e87-c25b-49cf-92b8-747b053930c2 | 2026-03-02 | Warnings | M005 |
| HAND SANITIZER lsland Coconut | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf3a822-27d2-efef-e063-6294a90a0502 | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cherry Blossom | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf48a93-345d-b901-e063-6394a90ab41b | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Cucumber Melon | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf552a4-b8b3-6fe3-e063-6394a90a722a | 2026-03-01 | Warnings | M005 |
| HAND SANITIZER Watermelon Sugar | ALCOHOL HAND SANITIZER | PT SUPER HOME PRODUCT INDONESIA | 4bf57b6e-c271-b4c6-e063-6394a90a63c6 | 2026-03-01 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | TRIFECTA PHARMACEUTICALS USA LLC | e0a2a907-9c3a-4c4e-e053-2995a90abb91 | 2026-03-01 | Warnings | M005 |
| FOLUPIA FUNGAL NAIL RENEWAL | FOLUPIA FUNGAL NAIL RENEWAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4bcacd53-9446-67ec-e063-6294a90a209e | 2026-02-27 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | Preferred Pharmaceuticals Inc. | d6f5c6b5-5e56-462f-8c47-7986ce53669d | 2026-02-25 | Warnings | M005 |
| Lakeim FUNGAL NAIL RENEWAL Kit | FUNGAL NAIL RENEWAL KIT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b6aae50-b219-beee-e063-6394a90ab415 | 2026-02-22 | Warnings | M005 |
| Hermon Jock Itch spray. | MICONAZOLE NITRATE 2% | Beautivity LLC | 4b633528-667a-f34e-e063-6294a90a2b3d | 2026-02-21 | Warnings | M005 |
| Lakeim Fungal Nail Repair Pen | FUNGAL NAIL REPAIR PEN | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b23c3a6-51da-7875-e063-6394a90a1467 | 2026-02-18 | Warnings | M005 |
| OSIMOON FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Guangzhou Jingliang Cosmetics Co., Ltd. | 4b113f31-1a82-a3ca-e063-6394a90a3231 | 2026-02-17 | Warnings | M005 |
| Hermon Ringworm Antifungal soap. | CLOTRIMAZOLE 1% | Beautivity LLC | 48405a7c-14cd-b3a0-e063-6394a90a9fc9 | 2026-02-13 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal soap. | TEA TREE OIL ANTIFUNGAL SOAP | RoyceDerm LLC | 3a6d1e32-a38b-3dde-e063-6394a90a88f3 | 2026-02-13 | Warnings | M005 |
| Happy Nuts Jock Itch Powder | MICONAZOLE NITRATE | Suit Up Brands LLC | 42e2d9df-6537-b3a1-e063-6394a90a47b7 | 2026-02-13 | Warnings | M005 |
| Nail Antifungal Treatment | TOLNAFTATE 1% FUNGI NAIL | BENM INC. | 2ea24785-c648-4104-e063-6294a90ab12f | 2026-02-12 | Warnings | M005 |
| Hermon Ringworm Treatment Kit | MICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1% | Beautivity LLC | 4a9d9c6e-0e0f-d539-e063-6294a90acb57 | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Antifungal Soothing Cream | ANTIFUNGAL SOOTHING CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a077685-4177-bc0d-e063-6294a90a461b | 2026-02-12 | Warnings | M005 |
| PHARMBANNER FUNGAL NAIL RENEWAL | FUNGAL NAIL RENEWAL | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a08ec6c-03ae-b9e5-e063-6394a90a0afb | 2026-02-12 | Warnings | M005 |
| PHARMBANNER Tinea Versicolor Cream | TINEA VERSICOLOR CREAM | Shenzhen Xinxin Yunhai Technology Co., Ltd. | 3a095194-c7ea-7f30-e063-6294a90a7ea1 | 2026-02-12 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 87525-004-01 | 87525000401 | 1 TUBE in 1 BOX (87525-004-01) / 28.4 g in 1 TUBE | 1 tube | 2026-04-30 | No | No | Current |
| 87525-004-02 | 87525000402 | 1 TUBE in 1 BOX (87525-004-02) / 113.4 g in 1 TUBE | 1 tube | 2026-04-30 | No | No | Current |