Anti- Fungal Miconazole Nitrate
- Product NDC
- 56104-253
- 11-digit product format
- 561040253
- Labeler code
- 56104
- Product ID
- 56104-253_3bba5b9f-d184-6f93-e063-6394a90ae951
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Premier Brands of America Inc.
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-04-11
- Marketing end
- 2027-01-31
- Substance
- MICONAZOLE NITRATE
- Active strength
- 1.42 g/71g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- 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
- Anti- Fungal Miconazole Nitrate
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 1.42 g/71g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998461 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f186bdc1-db6c-0fab-e053-2995a90a7c58 | 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 |
|---|---|---|---|---|---|---|
| 56104-253-01 | Anti- Fungal Miconazole Nitrate | 71 g in 1 BOTTLE, PLASTIC | POWDER | 71 | 7 |
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 |
|---|---|---|---|---|---|---|
| Myco Nail A Antifungal Solution | UNDECYLENIC ACID | Kramer Novis | 550358d7-69e8-4ea3-bcf9-d647c457287d | 2025-12-04 | Warnings | M005 |
| Tea Tree Oil Antifungal Soaps | TOLNAFTATE | Nanjing Jitaxing Technology Co., LTD | 4517d3a7-9144-b91d-e063-6294a90a4990 | 2025-12-03 | Warnings | M005 |
| Miconazole Nitrate | MICONAZOLE NITRATE | A-S Medication Solutions | 23ca78c0-16a9-455c-99a7-b9a9a3affa60 | 2025-12-03 | Warnings | M005 |
| Gembooxt Nail Fungus Solution | GEMBOOXT NAIL FUNGUS SOLUTION | Guangdong Quadrant Ecological Technology Co., Ltd. | 44f5c1bc-decf-beef-e063-6394a90ab562 | 2025-12-02 | Warnings | M005 |
| WELMATE Clotrimazole Topical Solution | CLOTRIMAZOLE | YYBA CORP | dc5bac4a-938c-4678-89ac-a899440c6a3c | 2025-12-02 | Warnings | M005 |
| Tolnaftate Cream 1% ANTIFUNGAL | TOLNAFTATE | CARDINAL HEALTH 110 dba LEADER | bb14825c-518d-bfba-e053-2995a90a7889 | 2025-12-02 | Warnings | M005 |
| ProCure Antifungal | MICONAZOLE NITRATE 2% | Twin Med LLC | 3d375325-ddad-f1e1-e063-6394a90a679f | 2025-12-01 | Warnings | M005 |
| CAREALL Clotrimazole | CLOTRIMAZOLE | New World Imports, Inc | 0a6cb1f7-a2a2-46a2-ae63-d205318996f0 | 2025-12-01 | Warnings | M005 |
| CAREALL Miconazole Nitrate | MICONAZOLE NITRATE | New World Imports, Inc | bed775be-8bcb-44c2-9b9f-8bb25b4b2453 | 2025-12-01 | Warnings | M005 |
| CAREALL Tolnaftate | TOLNAFTATE | New World Imports, Inc | cabf84c1-1500-46fe-b226-b16d4a0666c7 | 2025-12-01 | Warnings | M005 |
| Trimazole | CLOTRIMAZOLE | Trifluent Pharma LLC | a3bafc52-1404-4e0b-84c1-e28bffcb091e | 2025-12-01 | Warnings | M005 |
| APUREE Pure Nailtific Extra-Strength Fungal Nail Patches | APUREE PURE NAILTIFIC EXTRA-STRENGTH FUNGAL NAIL PATCHES | Guangzhou Meixi Biotechnology Co., Ltd. | 445354d8-bec2-0fd9-e063-6394a90a0099 | 2025-11-24 | Warnings | M005 |
| Antifungal Liquid | TOLNAFTATE | VALU MERCHANDISERS, CO | f4abb499-6893-9efb-e053-2995a90a33ed | 2025-11-24 | Warnings | M005 |
| Tolnafate | TOLNAFTATE ATHLETES FOOT POWDER SPRAY TALC FREE | VALU MERCHANDISERS, CO | 9ac97d4a-169b-49ff-aa34-ccb5b43726a1 | 2025-11-24 | Warnings | M005 |
| Tolnafate | FOOT ODOR CONTROL POWDER SPRAY | VALU MERCHANDISERS, CO | 51b69b0f-d63f-4fe0-87e6-722f95568761 | 2025-11-24 | Warnings | M005 |
| Miconazole Nitrate Antifungal Powder | MICONAZOLE NITRATE ANTIFUNGAL POWDER | Marlex Pharmaceuticals, Inc. | de4f703c-39e9-855e-e053-2a95a90a6ea9 | 2025-11-21 | Warnings | M005 |
| Odor-Eaters Athletes Foot | TOLNAFTATE | Blistex Inc. | 20d795d1-2345-4d4f-8439-07ad11ff8f65 | 2025-11-21 | Warnings | M005 |
| Derman Antifungal | ZINC UNDECYLENATE | Compania Internacional de Comercio, S.A.P.I de C.V. | 0129d801-90f6-49fd-857f-27d6ba9fc66c | 2025-11-19 | Warnings | M005 |
| Clotrimazole | CLOTRIMAZOLE | A-S Medication Solutions | 9afb964c-9b88-4701-adcf-7070e25cb6c1 | 2025-11-19 | Warnings | M005 |
| AU KAH CHUEN ANTIFUNGAL | CLOTRIMAZOLE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 3a262bcd-e6c0-4554-ab1c-9c861f90e190 | 2025-11-18 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998461 | miconazole nitrate 2 % Topical Powder | PSN | f186bdc1-db6c-0fab-e053-2995a90a7c58 | 7 |
| 998461 | miconazole nitrate 0.02 MG/MG Topical Powder | SCD | f186bdc1-db6c-0fab-e053-2995a90a7c58 | 7 |
| 998461 | miconazole nitrate 2 % Topical Powder | SY | f186bdc1-db6c-0fab-e053-2995a90a7c58 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 56104-253-01 | 56104025301 | 71 g in 1 BOTTLE, PLASTIC (56104-253-01) | 71 g | 2023-01-05 | 2027-01-31 | No | No | Current |