Miconazole Nitrate
- Product NDC
- 68599-1471
- 11-digit product format
- 685991471
- Labeler code
- 68599
- Product ID
- 68599-1471_2424691e-9201-a1b8-e063-6294a90a1cde
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Antifungal
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- McKesson
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-07-25
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 mg/100mg
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | 68599-1471 | Y | Unknown FDA exclusion code: Y | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 68599-1471 | 68599-1471-4 | Y | Unknown FDA exclusion code: Y | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… |
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
- Miconazole Nitrate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 2 mg/100mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| VW4H1CYW1K | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998483 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68599-1471-4 | 2021-09-15 | C162847 | 48780-1 | ba0f9c33-3bd0-a910-e053-dadaa90a0b85 | Antifungal |
| 68599-1471-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3bd0-a910-e053-dadaa90a0b85 | Antifungal |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68599-1471-4 | Miconazole Nitrate | 118 mg in 1 TUBE | CREAM | 118 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68599-1471 | MICONAZOLE NITRATE (ANTIFUNGAL) CREAM [MCKESSON] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241012_8dcca44a-16c7-7262-e053-2a95a90a1b23.zip |
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 |
|---|---|---|---|---|---|---|
| FUNGAL NAIL TREATMENT kit .liquid. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c93390-ee07-4f78-e063-6394a90add42 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit .cream. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c9d9fa-09ad-e26a-e063-6394a90a0ed9 | 2026-07-17 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56cb7085-87d8-4273-e063-6394a90ac5df | 2026-07-17 | Warnings | M005 |
| BeamBalm ANTIFUNGAL FOOT CARE | TOLNAFTATE 1% ANTIFUNGAL FOOT CARE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b10492-894c-33e1-e063-6394a90a8c0f | 2026-07-17 | Warnings | M005 |
| Foot Choice-Nail Fungal Pen | UNDECYLENIC ACID | Foot Choice LLC | 4b0036a6-8751-4f44-b6b1-5be57fa92cdc | 2026-07-17 | Warnings | M005 |
| 2% MICONAZOLE NITRATE ANTIFUNGAL Cream | 2% MICONAZOLE NITRATE ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56b54359-db21-b8b4-e063-6394a90a6f8c | 2026-07-16 | Warnings | M005 |
| DRAVYNOR BALANITIS RELIEF Cream | MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56b76a52-0743-4fe6-e063-6294a90a98a8 | 2026-07-16 | Warnings | M005 |
| 5% Benzoyl Peroxide FOLLICULITIS Cream | 5% BENZOYL PEROXIDE FOLLICULITIS CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 56c558fa-303f-fc52-e063-6394a90a72f0 | 2026-07-16 | Warnings | M005 |
| Antifungal Ringworm Treatment Cream | MICONAZOLE NITRATE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 56a2ceea-c4c0-c30c-e063-6394a90a0e6a | 2026-07-15 | Warnings | M005 |
| Medi-First Antifungal Cream Miconazole Cream | MICONAZOLE | Unifirst First Aid Corporation | 56a51b75-9c23-bcd2-e063-6394a90a9b12 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Tinea Treatment | CLEAR ROOT LABS TINEA TREATMENT | Aidance Scientic Inc., DBA Aidance Skincare & Topicals | 56a67bad-c677-d3b7-e063-6394a90ad205 | 2026-07-15 | Warnings | M005 |
| Clear Root Labs Antifungal Treatment | CLEAR ROOT LABS ANTIFUNGAL TREATMENT | Aidance Scientific, Inc., DBA Aidance Skincare & Topicals | 5696bf23-230a-5f37-e063-6294a90a7413 | 2026-07-15 | Warnings | M005 |
| BeamBalm ANTIFUNGAL NAIL Liquid | TOLNAFTATE 1% ANTIFUNGAL NAIL LIQUID | Jiangxi Yudexi Pharmaceutical Co., LTD | 56b17e50-bff1-5eb0-e063-6294a90a3c08 | 2026-07-15 | Warnings | M005 |
| terrasil Antifungal Cleansing Bar | CLOTRIMAZOLE | Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions | 10a4fde0-87e1-4474-bcb5-255b0a7f1ecb | 2026-07-14 | Warnings | M005 |
| OAKDOLCHE Tea Tree Oil Antifungal | TOLNAFTATE | Nanjing Qiaotun Technology Co., Ltd. | 569dee15-e68d-220e-e063-6294a90af7c5 | 2026-07-14 | Warnings | M005 |
| Kimtara Nail Fungus Treatment | KIMTARA NAIL FUNGUS TREATMENT | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 5678e260-10c4-f203-e063-6294a90a6223 | 2026-07-13 | Warnings | M005 |
| Aiilo NAIL FUNGUS TREATMENT | UNDECYLENIC ACID 25% | Guangzhou Huixue Biotechnology Co., Ltd. | 5689ac31-4d23-0fcc-e063-6394a90ac75b | 2026-07-13 | M005 | |
| MIWIFY ANTIFUNGAL NAIL REPAIR PEN | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PEN | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 56519b25-f3c8-bcac-e063-6394a90af879 | 2026-07-11 | Warnings | M005 |
| Joymeey FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5652a22e-7b43-3c31-e063-6294a90ae4f1 | 2026-07-11 | Warnings | M005 |
| iBeaLee Nail Repair Pen | IBEALEE NAIL REPAIR PEN | Shenzhen Earth Surface Trading Co., Ltd. | 564dc711-7fe2-7a8d-e063-6294a90aac26 | 2026-07-10 | Warnings | M005 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998483 | miconazole nitrate 2 % Topical Cream | PSN | 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 3 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 3 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | 8dcca44a-16c7-7262-e053-2a95a90a1b23 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68599-1471-4 | 68599147104 | 118 mg in 1 TUBE (68599-1471-4) | 118 mg | 2019-07-25 | 0000-00-00 | No | No | Current |