Remedy with Phytoplex
- Product NDC
- 53329-171
- 11-digit product format
- 533290171
- Labeler code
- 53329
- Product ID
- 53329-171_efcfbf86-bddd-1bba-e053-2a95a90ad29a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Miconazole Nitrate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Medline Industries, LP
- Application
- M005
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2016-04-11
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53329-171 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 53329-171 | 53329-171-10 | D | Discontinued by firm | 2026-10-12 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 53329-171 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53329-171 | 53329-171-10 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53329-171-10 | GM - Gram | 53329-171 | 784fceae-297e-4eee-aa66-95f5168b4853 | 1 | 2020-01-03 |
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.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53329-171-10 | 53329017110 | 71 g in 1 TUBE (53329-171-10) | 71 g | 2016-04-11 | 0000-00-00 | No | No | Current |