Medline
- Product NDC
- 53329-218
- 11-digit product format
- 533290218
- Labeler code
- 53329
- Product ID
- 53329-218_42f3af59-a020-421e-e063-6294a90a6eab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-10-01
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/100g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- 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
- Medline
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 20 mg/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1ea444eb-f2f5-8c63-e063-6294a90acac8 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 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 |
|---|---|---|---|---|---|---|
| 53329-218-44 | Medline | 113 g in 1 TUBE | CREAM | 113 | 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 |
|---|---|---|---|---|---|---|
| Athletes Foot | MICONAZOLE NITRATE | Premier Brands of America Inc | 52d0909a-f404-0af4-e063-6394a90a3d0c | 2026-06-01 | Warnings | M005 |
| Kopa Haiku Antifungal Cream | MICONAZOLE NITRATE 2% | Trovina Co. Ltd | 431483f6-2386-9f5c-e063-6294a90af104 | 2026-06-01 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | Walgreens Company | 3f8d45e1-54a2-a658-e063-6294a90a6cbb | 2026-06-01 | Warnings | M005 |
| Remedy Nails | UNDECYLENIC ACID | Adwill Labs Inc | 4e87b76c-c430-466a-bc30-fe1785c7c660 | 2026-06-01 | Warnings | M005 |
| Anytalk Nail Fungus Treatment 15ml (1% Tonailate) | TOLNAFTATE1% | Guangzhou Huixue Biotechnology Co., Ltd. | 52f1f654-fba3-e90e-e063-6394a90a1df4 | 2026-05-29 | Warnings | M005 |
| RoyceDerm Tea Tree Oil Antifungal .spray. | CLOTRIMAZOLE 1% | RoyceDerm LLC | 52da8be4-467c-c011-e063-6294a90a166f | 2026-05-28 | Warnings | M005 |
| Terramed Just Think Comfort Jock Itch Antifungal Treatment | MICONAZOLE NITRATE | Rida LLC | 2acb9027-8f20-4b77-9b45-17fe11622c7c | 2026-05-27 | Warnings | M005 |
| Quali Life ANTIFUNGAL TEA TREE | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 52b3b0df-3f62-f9bc-e063-6394a90a52b3 | 2026-05-26 | Warnings | M005 |
| ANTIFUNGAL PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b51877-e04c-569e-e063-6394a90a2fc9 | 2026-05-26 | Warnings | M005 |
| NAIL EXTRA STRENGTH REPAIR PEN | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6208d-53e4-eaa0-e063-6394a90abe7a | 2026-05-26 | Warnings | M005 |
| Toenail Fungus Pen Preventative | UNDECYLENIC ACID | Guangzhou Mizi Biotechnology Co., Ltd. | 52b6766f-948b-2602-e063-6294a90a03cf | 2026-05-26 | Warnings | M005 |
| KDMAN | TOLNAFTATE | Dongguan Youmi Trading Co., Ltd | 52a4e836-2059-a49f-e063-6394a90a6556 | 2026-05-25 | Warnings | M005 |
| PUTRIZEN | UNDECYLENIC ACID, TOLNAFTATE | Guangzhou Lianbiquan Biological Technology co., Ltd | 52a58f24-2a11-4d34-e063-6394a90a2924 | 2026-05-25 | Warnings | M005 |
| Eye CareSpray | EYELID CLEANSING SPRAY | Shenzhen Shierjie Biological Engineering Co., LTD | 52aef5dd-ff33-cace-e063-6294a90a415a | 2026-05-25 | Warnings | M005 |
| Saviland PRO Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 5250003a-8d3a-818b-e063-6294a90aa659 | 2026-05-21 | Warnings | M005 |
| Saviland SSPro X Series Extra Strength Toenail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52506297-44d7-b2a7-e063-6394a90a0a3c | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52512e7e-5e28-4383-e063-6294a90a448a | 2026-05-21 | Warnings | M005 |
| Vrenmol Extra Strength Nail Renewal Patches | TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52516861-e386-d0cb-e063-6394a90a17d0 | 2026-05-21 | Warnings | M005 |
| SSPROTIP X Extra Strength Toenail Renewal Solution | TOLNAFTATE,UNDECYLENIC ACID | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 52519110-a3c9-21da-e063-6294a90abbce | 2026-05-21 | Warnings | M005 |
| Fungal Nail Repair Pen | UNDECYLENIC ACID | Yunqi Cosmetics (Shenzhen) Co., Ltd | 523c32f7-b803-bf79-e063-6394a90aad5a | 2026-05-20 | Warnings | M005 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53329-218-44 | 53329021844 | 113 g in 1 TUBE (53329-218-44) | 113 g | 2024-10-01 | No | No | Current |