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 |
|---|---|---|---|---|---|---|
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | Wal-Mart Stores, Inc | af4d4e9e-8678-3a80-e053-2995a90a677f | 2026-04-22 | Warnings | M005 |
| Tolnaftate | ANTIFUNGAL LIQUID SPRAY | Wal-Mart Stores, Inc | af4ebb3b-041e-30dd-e053-2995a90a8d2d | 2026-04-22 | Warnings | M005 |
| Tolnafate | TOLNAFTATE POWDER SPRAY | Wal-Mart Stores, Inc | af4dd045-ca51-42b9-e053-2a95a90a0327 | 2026-04-22 | Warnings | M005 |
| 4oz | MICONAZOLE | Nabrace LLC | 4f912a20-e0f7-23c1-e063-6294a90a55d6 | 2026-04-18 | Warnings | M005 |
| Nabrace Wipes for Ringworm, Jockitch and Athlete Feet | NABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEET | Nabrace LLC | 4fc3ddc8-08a2-ae50-e063-6294a90a1e07 | 2026-04-18 | Warnings | M005 |
| SimplyVital Antifungal Clotrimazole | CLOTRIMAZOLE | Alpha Plants Inc | 44881106-3ab4-4103-9c48-1da435ab5b13 | 2026-04-16 | Warnings | M005 |
| medicated | MICONAZOLE | Nabrace LLC | 4f90d8ad-33d9-0043-e063-6394a90a4466 | 2026-04-16 | Warnings | M005 |
| Ingrown Nail Treatment | JALAWEF INGROWN NAIL TREATMENT | Consilii LLC | 1ac2d7fc-1806-7925-e063-6294a90ad3b5 | 2026-04-15 | Warnings | M005 |
| RDVHDLW Extra Strength NAIL REPAIR PEN | TOLNAFTATE, UNDECYLENIC ACID | Shenzhen Joyuflsh Technology Co.,Ltd. | 4f68796c-11e1-e5f7-e063-6394a90adeb1 | 2026-04-14 | Warnings | M005 |
| ProBliva Psoriasis Scalp .spray. | SALICYLIC ACID 3% | CAVTECH HOLDING LLC | 4f695604-51c5-c1b7-e063-6294a90ab5ae | 2026-04-14 | Warnings | M005 |
| OSIMOON Fungal Nail Treatment | FUNGAL NAIL TREATMENT | Guangzhou Jingliang Cosmetics Co., Ltd. | 4f7817db-cd71-fba9-e063-6294a90a9cdf | 2026-04-14 | Warnings | M005 |
| Quali Life ANTIFUNGAL PERSIMMON | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 4f520058-3b81-574e-e063-6294a90a2eae | 2026-04-13 | Warnings | M005 |
| Quali Life ANTIFUNGAL CHARCOAL | TOLNAFTATE | Guangdong Aimu Biological Technology Co., Ltd | 4f538041-e2f1-4a5f-e063-6294a90a54cf | 2026-04-13 | Warnings | M005 |
| RoyceDerm tinea ANTIFUNGAL .cream. and .soap. | CREAM AND SOAP | RoyceDerm LLC | 4f4ef2d0-98fa-e791-e063-6394a90a7045 | 2026-04-12 | Warnings | M005 |
| Nailtific Daytime Treatment Antifungal Pen Refill | NAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILL | Guangzhou Meixi Biotechnology Co., Ltd. | 4257ee32-0d8f-08d4-e063-6294a90a4a89 | 2026-04-11 | Warnings | M005 |
| Nailtific Nighttime Antifungal Renewal Pen Refill | TOLNAFTATE | Guangzhou Meixi Biotechnology Co., Ltd. | 42634fc7-d0c7-4813-e063-6294a90a702d | 2026-04-11 | Warnings | M005 |
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Chain Drug Marketing Association Inc | 1a4f4d10-6782-ddb4-e063-6294a90ac206 | 2026-04-09 | Warnings | M005 |
| Extra Strength Toenail Renewal Solution | UNDECYLENIC ACID, TOLNAFTATE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 4eed68e6-6814-0181-e063-6394a90a888e | 2026-04-08 | Warnings | M005 |
| TAGOQHIA Extra Strength NAIL REPAIR PEN | TOLNAFTATE, UNDECYLENIC ACID | Guangzhou Borderless Technology Co., Ltd. | 4eefbef4-7643-dca4-e063-6394a90a72c1 | 2026-04-08 | Warnings | M005 |
| ZYNTHIX | UNDECYLENIC ACID SOLUTION | Shenzhen Siwei Yijiu Trading Co., Ltd. | 4ef4a167-f673-efb4-e063-6294a90a3026 | 2026-04-08 | 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 |