Miconazole
- Product NDC
- 81993-010
- 11-digit product format
- 819930010
- Labeler code
- 81993
- Product ID
- 81993-010_53592633-e782-5073-e063-6294a90a620a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole nitrate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Zennova LLC
- Application
- M005
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-10-16
- Substance
- MICONAZOLE NITRATE
- Active strength
- 20 mg/g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Miconazole
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MICONAZOLE NITRATE | 20 mg/g |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 81993-010-01 | 81993001001 | 1 TUBE in 1 CARTON (81993-010-01) / 30 g in 1 TUBE | 1 tube | 2026-10-16 | No | No | Current |