Remedy Antifungal

Product NDC: 53329-162
11-digit product format: 533290162
Labeler code: 53329
Product ID: 53329-162_5afad95f-a821-ae56-e063-6294a90a7d24
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
Marketing end: 2026-12-01
Substance: MICONAZOLE NITRATE
Active strength: 2 g/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
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		2026-10-05
excluded package	package	53329-162	53329-162-04	D	Discontinued by firm		2026-10-05

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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Remedy Antifungal
Brand name suffix: With Olivamine

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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EZBIORT 1% Tolnaftate Nail Essence with Biotin	TOLNAFTATE	Guangzhou Borderless Technology Co., Ltd.	5629df38-1079-be4f-e063-6394a90a1c6a	2026-07-09	Warnings	Exact identifier application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal Pen	UNDECYLENIC ACID 25% ANTIFUNGAL PEN	Shenzhen Xituo Electronics Co., Ltd	563a6704-f662-3f08-e063-6394a90a4369	2026-07-09	Warnings	Exact identifier application number: M005
Antifungal Cream	ANTIFUNGAL	Preferred Pharmaceuticals Inc.	c6098653-351a-449f-9b1a-0c617074f2b9	2026-07-08	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Renewal	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	561b650d-028c-687c-e063-6394a90a166a	2026-07-08	Warnings	Exact identifier application number: M005
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	561d3e64-ab9c-1074-e063-6394a90a1298	2026-07-08	Warnings	Exact identifier application number: M005
Beautifier Life ALCOHOL WIPES	BEAUTIFIER LIFE ALCOHOL WIPES	Shenzhen Shierjie Biological Engineering Co., LTD	323ef469-e37c-00ad-e063-6394a90ab6f7	2026-07-08	Warnings	Exact identifier application number: M005
Folliculitis Treatment Cream	MICONAZOLE NITRATE 2%	Guangxi Keyun E-commerce Co., Ltd.	5625652a-193d-0318-e063-6294a90a56f3	2026-07-08	Warnings	Exact identifier application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit	FUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KIT	PureWellness LLC	25db8c55-0fa9-4795-8e05-4d3a7aaf0148	2026-07-06	Warnings	Exact identifier application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	3b9ab6e0-8773-f909-e063-6394a90ac1c9	2026-07-03	Warnings	Exact identifier application number: M005
TOENAIL FUNGUS TREATMENT	25% UNDECYLENIC ACID	100 KARMA INC	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Toenail Fungus Treatment Kit	TOENAIL FUNGUS TREATMENT	100 KARMA INC	3d4bbc65-955f-8fd8-e063-6294a90adc44	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Nailtonic Repair Pens	25% UNDECYLENIC ACID	100 KARMA INC	4a9c32b3-e78d-3c85-e063-6394a90a7bf2	2026-07-03	Warnings	Exact identifier application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	48e377b4-abb1-34cf-e063-6294a90a2ea3	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.	25% UNDECYLENIC ACID AND TOLNAFTATE 1%	100 KARMA INC	4c197131-9ca8-6024-e063-6294a90aa9cb	2026-07-03	Warnings	Exact identifier application number: M005
Treatonic Antifungal Pen	25% UNDECYLENIC ACID	100 KARMA INC	52d89172-e8a7-70c0-e063-6294a90a3563	2026-07-03	Warnings	Exact identifier application number: M005
FUNGINIX ANTI-FUNGAL TREATMENT	UNDECYLENIC ACID	The Sisquoc Healthcare Corporation	92db5433-5a1b-4cb9-b8eb-217c2a807a99	2026-07-02	Warnings	Exact identifier application number: M005
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	Warnings	Exact identifier application number: M005
Terpenicol Antifungal Cream	MICONAZOLE NITRATE	Blaine Labs Inc.	9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa	2026-07-01	Warnings	Exact identifier application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACK	ZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACK	Jiangxi Yudexi Pharmaceutical Co., LTD	50044b55-8553-ca52-e063-6394a90a0e54	2026-07-01	Warnings	Exact identifier application number: M005
VENROCK	UNDECYLENIC ACID	Guangzhou Oupeng Cosmetics Co., Ltd.	558af06e-6fe1-c926-e063-6394a90a738c	2026-07-01	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	2026-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
162 Antifungal Cream 2% Miconazole Nitrate	Medline Industries, LP	2026-09-08	HUMAN OTC DRUG LABEL	8