Remedy with Phytoplex Antifungal Clear

Product NDC
53329-167
11-digit product format
533290167
Labeler code
53329
Product ID
53329-167_9a29bd2c-797b-fa99-e053-2a95a90a3c40
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Medline Industries Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-01
Marketing end
2022-01-01
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-167DDiscontinued by firm2026-10-12
excluded packagepackage53329-16753329-167-10DDiscontinued by firm2026-10-12
excluded packagepackage53329-16753329-167-96DDiscontinued by firm2026-10-12

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.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-167-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-167-96d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-167-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-167-96f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-167-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-167-962ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-167-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-167-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-167-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-167-96cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-167-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-167-96cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-167-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-167-96302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-167-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-167-96ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-167-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-167-960efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-167-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-167-96ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-167-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-167-96367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-167-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-167-96557ba5c1ecfa…9c80585c8c6e…

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 table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-167-10GM - Gram53329-167ad1dcec6-0f57-4c85-b70b-ecac287e44a812015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
MICONAZOLEACTIVE MOIETY7NNO0D7S5MREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
CLOVEINACTIVE INGREDIENTK48IKT5321REMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0REMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
OLIVE OILINACTIVE INGREDIENT6UYK2W1W1EREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3
SOYBEAN OILINACTIVE INGREDIENT241ATL177AREMEDY WITH PHYTOPLEX ANTIFUNGAL CLEAR (MICONAZOLE NITRATE) OINTMENT [MEDLINE INDUSTRIES INC.]3