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 |
|---|---|---|---|---|---|---|
| Velloryn ANTIFUNGAL Cream | ZINC UNDECYLENATE, UNDECYLENIC ACID | Guangdong Quadrant Ecological Technology Co., Ltd. | 4e38e1f1-0466-5b91-e063-6294a90a66c4 | 2026-03-30 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Daytime Antigungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4e3d226b-57f1-75a6-e063-6394a90a96cd | 2026-03-30 | Warnings | M005 |
| APUREE Nailtific Extra-Max Strength Nighttime Antifungal | APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL | Guangzhou Meixi Biotechnology Co., Ltd. | 4e3e8895-34b4-de69-e063-6294a90a5532 | 2026-03-30 | M005 | |
| Miconazole Nitrate | ATHLETES FOOT POWDER SPRAY TALC FREE | CVS Pharmacy | 3380263d-ee7b-4946-a467-35a24789a901 | 2026-03-27 | Warnings | M005 |
| Micro-Guard (AF) | MICONAZOLE NITRATE | Coloplast Corp | a43a94d0-fec0-470f-bdb4-535dcce6d1e0 | 2026-03-27 | Warnings | M005 |
| Suave Antibacterial Hand Wash Fresh Citrus | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d77ec6-a1d1-13dc-e063-6394a90a95f4 | 2026-03-26 | Warnings | M005 |
| Suave Antibacterial Hand Wash Deeply Clean | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d83736-66da-abb9-e063-6294a90a3d67 | 2026-03-26 | Warnings | M005 |
| Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera | LIQUID HAND WASH ANTIBACTERIAL | Suave Brands Co, LLC | 41d8848c-d157-6e2c-e063-6294a90aa259 | 2026-03-26 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch | ANTIFUNGAL TREATMENT KIT | Beautivity LLC | 4800a93b-7042-827b-e063-6294a90acd95 | 2026-03-25 | Warnings | M005 |
| Toenail Fungus Treatment | TERBINAFINE | Shenzhen Wankelai E-commerce Co., Ltd. | 4dc1d7f7-e4ae-c54b-e063-6394a90aa420 | 2026-03-24 | Warnings | M005 |
| Lasolex Liquid Solution | CLOTRIMAZOLE 1% | PureTek Corporation | 4dc9e64d-8235-b218-e063-6394a90a0157 | 2026-03-24 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment .Soap. Bar | TOLNAFTATE 1% | Beautivity LLC | 4dbbf09b-5bc1-501b-e063-6394a90a2a9d | 2026-03-23 | Warnings | M005 |
| Hermon Jock Itch Antifungal Treatment Cream | MICONAZOLE NITRATE 2% | Beautivity LLC | 4dbc521c-2f5f-9736-e063-6294a90ad85d | 2026-03-23 | Warnings | M005 |
| seebeellar clotrimazole 1% antifungal cream | SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 4d80e551-76c2-150a-e063-6394a90a7996 | 2026-03-20 | Warnings | M005 |
| Nail Fungal Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5b5c22-4781-6391-e063-6294a90a7010 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MADRID MUSE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5cecf6-c232-6cd9-e063-6394a90a03e9 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER VALENCIA VIBES | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5de4d6-4c58-f393-e063-6294a90a323a | 2026-03-19 | Warnings | M005 |
| Toenail Fungus Pen | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 4d5e256f-7fd5-f903-e063-6394a90a1160 | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MALLORCA BREEZE | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d5e50de-62fd-f9e9-e063-6394a90af0bd | 2026-03-19 | Warnings | M005 |
| HAND SANITIZER MAR BELLA | ALCOHOL HAND SANITIZER | CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD. | 4d6005d9-5d4d-033e-e063-6294a90ad36f | 2026-03-19 | 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 |