Miconazole Nitrate
- Product NDC
- 53943-120
- 11-digit product format
- 539430120
- Labeler code
- 53943
- Product ID
- 53943-120_c790c68d-c9da-031c-e053-2a95a90a0529
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Anti-fungal Powder Miconazole Nitrate Talc Free
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Discount Drug Mart
- Application
- part333C
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2018-02-12
- Marketing end
- 0000-00-00
- Substance
- MICONAZOLE NITRATE
- Active strength
- 1 g/71g
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53943-120 | D | Discontinued by firm | 2026-10-20 | ||
| excluded package | package | 53943-120 | 53943-120-25 | D | Discontinued by firm | 2026-10-20 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53943-120-25 | 53943012025 | 71 g in 1 BOTTLE, PLASTIC (53943-120-25) | 71 g | 2018-02-12 | 0000-00-00 | No | No | Current |