MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
- Product NDC
- 77338-041
- 11-digit product format
- 773380041
- Labeler code
- 77338
- Product ID
- 77338-041_1bbb26c7-7122-8c78-e063-6394a90ae6a6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MICONAZOLE NITRATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ASTONEA LABS PRIVATE LIMITED
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-03-22
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 g/100g
- 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 77338-041-25 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 77338-041-25 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 77338-041-25 | 1332a3947898… | d4bfe170f9cd… |
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 2% Cream ANTIFUNGAL
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 2 g/100g |
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 |
|---|---|
| e66191a6-0c3c-7319-e053-2a95a90aae84 | 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 |
|---|---|---|---|---|---|
| 77338-041-25 | 2024-06-25 | C162847 | 48780-1 | 1030e365-5ae8-111a-e063-dadaa90a10e2 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL |
| 77338-041-25 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5ae8-111a-e063-dadaa90a10e2 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77338-041-25 | MICONAZOLE Nitrate 2% Cream ANTIFUNGAL | 113 g in 1 TUBE | CREAM | 113 | 2 |
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 |
|---|---|---|---|---|---|---|
| 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 | e66191a6-0c3c-7319-e053-2a95a90aae84 | 2 |
| 998483 | miconazole nitrate 20 MG/ML Topical Cream | SCD | e66191a6-0c3c-7319-e053-2a95a90aae84 | 2 |
| 998483 | miconazole nitrate 2 % Topical Cream | SY | e66191a6-0c3c-7319-e053-2a95a90aae84 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 77338-041-25 | 77338004125 | 113 g in 1 TUBE (77338-041-25) | 113 g | 2022-08-16 | 0000-00-00 | No | No | Current |