Miconazole nitrate
- Product NDC
- 55681-165
- 11-digit product format
- 556810165
- Labeler code
- 55681
- Product ID
- 55681-165_e69cd379-fdb6-b737-e053-2995a90aba3e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Antifungal
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- TWIN MED, LLC
- Application
- part333C
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-19
- Marketing end
- 0000-00-00
- Substance
- MICONAZOLE NITRATE
- Active strength
- 2 g/100g
- Pharmacologic classes
- Azole Antifungal [EPC], Azoles [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 55681-165 | | E | Excluded after deficient or non-compliant submission was not corrected | | 2026-10-05 |
| excluded package | package | 55681-165 | 55681-165-03 | E | Excluded after deficient or non-compliant submission was not corrected | | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55681-165-03 | Miconazole nitrate | 85 g in 1 BOTTLE, PLASTIC | POWDER | 85 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55681-165 | MICONAZOLE NITRATE (ANTIFUNGAL) POWDER [TWIN MED, LLC] | 3 | Legacy NDC, 1 package rows | 20240109_e69c8d1a-cf46-d3e1-e053-2995a90aaa75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55681-165-03 | 55681016503 | 85 g in 1 BOTTLE, PLASTIC (55681-165-03) | 85 g | 2022-08-19 | 0000-00-00 | No | No | Current |