Remedy Antifungal

Product NDC: 53329-162
11-digit product format: 533290162
Labeler code: 53329
Product ID: 53329-162_423e6bdd-db9d-cb4a-e063-6394a90a63cf
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-01-01
Substance: MICONAZOLE NITRATE
Active strength: 2 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	53329-162		D	Discontinued by firm		2026-08-10
excluded package	package	53329-162	53329-162-04	D	Discontinued by firm		2026-08-10

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-162-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-162-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-162-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-162-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-162-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-162-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-162-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-162-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-162-04	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-162-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-162-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-162-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Remedy Antifungal
Brand name suffix: With Olivamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VW4H1CYW1K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998483	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28c5183e-05b4-1754-e054-00144ff8d46c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
baf7f49c-75b6-496b-a00e-8e766a8e4f03	Product name	1	20210127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-162-04	Remedy AntifungalWith Olivamine	113 g in 1 TUBE	CREAM	113		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-162-04	ML - Milliliter	53329-162	4af9581d-0f34-4ab0-b335-aec27d6eb575	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-162	REMEDY ANTIFUNGAL WITH OLIVAMINE (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, LP]	6	Current NDC, Legacy NDC, 1 package rows	20240906_28c5183e-05b4-1754-e054-00144ff8d46c.zip

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.

Matched openFDA labels page 1 of 50 · 984 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemachlich Zu Hause Vaginal Antifungal Gel	MICONAZOLE NITRATE	Guangzhou Xinhongda Trading Service Co., Ltd.	563cfb57-f10c-96a6-e063-6294a90a2b93	2026-08-06	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	7fd4037e-d350-47b7-a7d9-a43b8e366fa0	2026-08-05	Warnings	Exact identifier application number: M005
Antifungal Liquid	TOLNAFTATE	Family Dollar Services, Inc	57c20748-fdad-b73b-e063-6294a90a1c17	2026-08-04	Warnings	Exact identifier application number: M005
Gembooxt RINGWORM Cream	MICONAZOLE NITRATE, HYDROCORTISONE	Guangdong Quadrant Ecological Technology Co., Ltd.	464a33c3-6d16-0cfd-e063-6294a90abf4b	2026-08-04	Warnings	Exact identifier application number: M005
YAMANGU FUNGAL NAIL RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL RENEWAL	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5843cc12-de66-ca47-e063-6294a90ae55b	2026-08-04	Warnings	Exact identifier application number: M005
Maximum Strength Antifungal Liquid	TOLNAFTATE	Meijer Distribution Inc	0b3eb169-b309-8c1a-e063-6294a90a726e	2026-08-03	Warnings	Exact identifier application number: M005
ProCure Antifungal Cream	MICONAZOLE NITRATE 2%	Twin Med LLC	39d55df5-8a8e-3a9b-e063-6294a90af20b	2026-08-03	Warnings	Exact identifier application number: M005
MiratiFul Nail Fungus Treatment	TOLNAFTATE	Texas MiratiFul Enterprises Inc.	35eb20e3-86d4-4bec-b572-3d5fe86ac74d	2026-08-03	Warnings	Exact identifier application number: 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	Exact identifier application number: M005
Ponamfo ANTIFUNGAL TREATMENT PEN	UNDECYLENIC	Guangzhou Bixiaoyu Trading Co., Ltd.	57a9ccff-270b-9769-e063-6394a90a5e0c	2026-07-28	Warnings	Exact identifier application number: M005
FUNGAL NAIL PATCHES	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	5240412c-4257-8e9d-e063-6394a90a0a12	2026-07-28	Warnings	Exact identifier application number: M005
FFPMAM Antifungal Cream	FFPMAM ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	57b7cf61-d4cd-53f7-e063-6394a90afc54	2026-07-28	Warnings	Exact identifier application number: M005
Youggle WART REMOVER	SALICYLIC ACID	Guangzhou Huixue Biotechnology Co., Ltd.	57a3744e-316c-8a3d-e063-6294a90a15d1	2026-07-27	Warnings	Exact identifier application number: M005
antifungal pen	ANTIFUNGAL PEN	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	5756256e-ed2b-4e13-e063-6294a90a1e0f	2026-07-24	Warnings	Exact identifier application number: 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	Exact identifier application number: M005
SERYNTH MULTI-PURPOSE FUNCUS	TOLNAFTATE 1% MULTI-PURPOSE FUNCUS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a6ea0c9-1495-8ede-e063-6294a90ad093	2026-07-23	Warnings	Exact identifier application number: 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	Exact identifier application number: M005
FUNGAL NAIL TREATMENT kit .liquid.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	5719942d-6b10-612e-e063-6294a90a4fe9	2026-07-21	Warnings	Exact identifier application number: 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	Exact identifier application number: 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	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
998483	miconazole nitrate 2 % Topical Cream	PSN	28c5183e-05b4-1754-e054-00144ff8d46c	7
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	28c5183e-05b4-1754-e054-00144ff8d46c	7
998483	miconazole nitrate 2 % Topical Cream	SY	28c5183e-05b4-1754-e054-00144ff8d46c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-162-04	53329016204	113 g in 1 TUBE (53329-162-04)	113 g	2007-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
162 Antifungal Cream 2% Miconazole Nitrate	Medline Industries, LP	2025-10-28	HUMAN OTC DRUG LABEL	7