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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Maximum Strength Antifungal Liquid | TOLNAFTATE | Meijer Distribution Inc | 0b3eb169-b309-8c1a-e063-6294a90a726e | 2026-08-03 | Warnings | M005 |
| ProCure Antifungal Cream | MICONAZOLE NITRATE 2% | Twin Med LLC | 39d55df5-8a8e-3a9b-e063-6294a90af20b | 2026-08-03 | Warnings | M005 |
| MiratiFul Nail Fungus Treatment | TOLNAFTATE | Texas MiratiFul Enterprises Inc. | 35eb20e3-86d4-4bec-b572-3d5fe86ac74d | 2026-08-03 | Warnings | M005 |
| LUCKSKY Fungal Nail Renewal | UNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWAL | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 57a73b60-bbac-97e6-e063-6294a90ab9a9 | 2026-07-28 | Warnings | M005 |
| Ponamfo ANTIFUNGAL TREATMENT PEN | UNDECYLENIC | Guangzhou Bixiaoyu Trading Co., Ltd. | 57a9ccff-270b-9769-e063-6394a90a5e0c | 2026-07-28 | Warnings | M005 |
| FUNGAL NAIL PATCHES | UNDECYLENIC ACID | Guangzhou Hechuang Commercial Service Co.,Ltd. | 5240412c-4257-8e9d-e063-6394a90a0a12 | 2026-07-28 | Warnings | M005 |
| FFPMAM Antifungal Cream | FFPMAM ANTIFUNGAL CREAM | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 57b7cf61-d4cd-53f7-e063-6394a90afc54 | 2026-07-28 | Warnings | M005 |
| Natural Vine Fungal Nail patches | TOLNAFTATE 1% | GETHSEMANE BRANCH CORPORATION | 57905962-0745-ceee-e063-6294a90a88dd | 2026-07-26 | Warnings | M005 |
| antifungal pen | ANTIFUNGAL PEN | GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd | 5756256e-ed2b-4e13-e063-6294a90a1e0f | 2026-07-24 | Warnings | M005 |
| SERYNTH ANTIFUNGAL NAIL TREATMENT PEN | UNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d59116a-bcd0-9ed4-e063-6394a90a6dbd | 2026-07-24 | Warnings | M005 |
| SERYNTH MULTI-PURPOSE FUNCUS | TOLNAFTATE 1% MULTI-PURPOSE FUNCUS | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a6ea0c9-1495-8ede-e063-6294a90ad093 | 2026-07-23 | Warnings | M005 |
| HELPS WITH NAGELPILZ | TOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUID | Shanghai Honghui Chuang Intelligent Technology Co., Ltd | 55753a4a-a4d0-a183-e063-6394a90acf11 | 2026-07-22 | Warnings | M005 |
| FUNGAL NAIL TREATMENT kit .liquid. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 5719942d-6b10-612e-e063-6294a90a4fe9 | 2026-07-21 | Warnings | M005 |
| BeamBalm ANTIFUNGAL CARE ESSENTIAL Oil | UNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OIL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ff57d2d-5e74-a995-e063-6394a90a3f9a | 2026-07-21 | Warnings | M005 |
| WERPEKA FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4f7a8273-b7af-d532-e063-6394a90aa63a | 2026-07-21 | Warnings | M005 |
| HTRCSW FUNGAL NAIL RENEWAL | UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN | Jiangxi Yudexi Pharmaceutical Co., LTD | 523bc484-511c-b603-e063-6394a90a55ae | 2026-07-21 | Warnings | M005 |
| DERMFREE Clotrimazole | CLOTRIMAZOLE1% CLOTRIMAZOLE | Jiangxi Yudexi Pharmaceutical Co., LTD | 49ab5abb-d311-505d-e063-6294a90a5616 | 2026-07-21 | Warnings | M005 |
| DERMFREE FUNGI NAIL | TOLNAFTATE 1% FUNGI NAIL | Jiangxi Yudexi Pharmaceutical Co., LTD | 49aba00d-9249-b403-e063-6394a90a787d | 2026-07-21 | Warnings | M005 |
| SKAPEMED SKIN REPAIR | TOLNAFTATE 1% SKIN REPAIR | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a20c32e-0551-aead-e063-6394a90a2aa7 | 2026-07-21 | Warnings | M005 |
| REINREUDE MULTI-PURPOSE TREATMENT | TOLNAFTATE 1% MULTI-PURPOSE TREATMENT | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a380945-9235-783a-e063-6294a90a094d | 2026-07-21 | Warnings | M005 |
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 |