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		2026-10-12
excluded package	package	53329-162	53329-162-04	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.

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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONIADBA Fungal Nail Treatment Swabs	TOLNAFTATE,UNDECYLENIC ACID	Shenzhen Boyimei Technology Co., Ltd.	3baa99ab-6d22-8d7d-e063-6294a90af3e8	2025-08-05	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	cca84334-2e2d-4991-9d1e-d5b7c9ffd392	2025-08-01	Warnings	Exact identifier application number: M005
RoyceDerm CoolDefense Refreshing Shower Gel	TOLNAFTATE 1.0%	RoyceDerm LLC	3b3216d6-8cc8-ea89-e063-6294a90ab691	2025-07-31	Warnings	Exact identifier application number: M005
SUNMARK MICONAZOLE NITRATE antifungal	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	7c15d95a-5b89-4789-8c91-3f61d7ec7707	2025-07-30	Warnings	Exact identifier application number: M005
Antifungal	MICONAZOLE NITRATE	Advanced Rx LLC	e13eb653-3916-444a-ae86-1738c0308b79	2025-07-28	Warnings	Exact identifier application number: M005
Meridian Unwrapped Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	a2b9570f-312c-4f46-994d-efe057b247aa	2025-07-28	Warnings	Exact identifier application number: M005
Meridian Antibacterial Deodorant	BENZETHONIUM CHLORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	b41b130f-48fd-47d4-a94e-74433ae44de2	2025-07-28	Warnings	Exact identifier application number: M005
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	bd567e91-7152-4612-83e0-8e8a00c2d2c5	2025-07-25	Warnings	Exact identifier application number: M005
Hongocura	UNDECYLENIC ACID, ZINC UNDECYLENATE	MENPER DISTRIBUTORS, INC.	c69b735e-0ffe-4328-bd9f-3c1ac6798c08	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura Pinceladas	UNDECYLENIC ACID	Menper Distributors, Inc.	4b9a3a70-d646-47c6-b969-5c4d759d23a4	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura M	UNDECYLENIC ACID	MENPER DISTRIBUTORS, INC.	b4adb7b0-59b4-4b3c-9b0e-1869bb543174	2025-07-22	Warnings	Exact identifier application number: M005
Hongocura S	UNDECYLENIC ACID	MENPER DISTRIBUTORS, INC.	4a21f371-bfc1-4e66-af16-55b3283872b7	2025-07-22	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Cream 1oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a37a3a8-9d05-926c-e063-6294a90a9ed8	2025-07-18	Warnings	Exact identifier application number: M005
FifthPulse Miconazole Nitrate Cream 4oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a382b79-dde9-dde0-e063-6294a90a53bb	2025-07-18	Warnings	Exact identifier application number: M005
FifthPulse clotrimazole cream 4oz	CLOTRIMAZOLE 1%	Front Pharmaceutical PLC	3a389093-48f2-29cb-e063-6294a90ada37	2025-07-18	Warnings	Exact identifier application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.	TEA TREE OIL ANTIFUNGAL SOAP.	Shenzhen Xinxin Yunhai Technology Co., Ltd.	3a0860b0-346e-7024-e063-6394a90ace81	2025-07-16	Warnings	Exact identifier application number: M005
TopCare Antifungal	CLOTRIMAZOLE	Topco Associates LLC	6757eb2a-73e0-4bd0-a332-5713fdf3445d	2025-07-16	Warnings	Exact identifier application number: M005
UpandUp Clotrimazole	CLOTRIMAZOLE	Target Corporation	cb2b7d38-9988-493b-9843-56c2f59eed2f	2025-07-16	Warnings	Exact identifier application number: M005
Jock Itch	CLOTRIMAZOLE	TARGET Corporation	1ae551e7-69de-4eef-b4f7-5e1a880e631d	2025-07-16	Warnings	Exact identifier application number: M005
Athletes Foot	CLOTRIMAZOLE	FRED'S, INC.	d2d8f44e-2dfa-446b-855e-86e0d6d2d0df	2025-07-15	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