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		2026-10-15
excluded package	package	53329-162	53329-162-04	D	Discontinued by firm		2026-10-15

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 43 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	DRS. CLOTRIMAZOLE	OL PHARMA TECH,LLC	b0e9fc77-6d5c-2472-e053-2995a90a3de4	2025-01-09	Warnings	Exact identifier application number: M005
Anti-Bacterial Wipes	BENZALKONIUM CHLORIDE	Tongling Jieya Biological Technology Co., Ltd.	d7aeb18f-abf2-49bd-a8a3-ac57f60fbe7d	2025-01-04	Warnings	Exact identifier application number: M005
AVON HeXashield Athletes Foot Cream	TOLNAFTATE	Tai Guk Pharm. Co., Ltd.	8f2b6a09-8cb0-0d17-e053-2995a90aa07f	2025-01-01	Warnings	Exact identifier application number: M005
Tolnaftate	TOLNAFTATE 1%	Trifecta Pharmaceuticals USA, LLC	091b907f-544a-86c9-e063-6294a90a5d87	2024-12-31	Warnings	Exact identifier application number: M005
terrasil Fungal Treatment	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	278290f9-be14-81a8-e063-6294a90ad8cc	2024-12-26	Warnings	Exact identifier application number: M005
DEO PEDICO ABOVE NEYMAR JR MEN	DEO PEDICO ABOVE NEYMAR JR MEN	BASTON INDUSTRIA DE AEROSSOIS LTDA	ed4a9844-f20b-da5d-e053-2995a90adc09	2024-12-26	Warnings	Exact identifier application number: M005
Vite20	MICONAZOLE NITRATE	Blaine Labs Inc.	28a8d0dd-aab9-44ff-bab6-7ec4b5036a71	2024-12-24	Warnings	Exact identifier application number: M005
Vite20	UNDECYLENIC ACID	Blaine Labs Inc.	18f8ea1c-360e-43c0-98df-5816af4dec66	2024-12-24	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1% ANTIFUNGAL	FAMILY WELLNESS TOLNAFTATE	Trifecta Pharmaceuticals USA, LLC	915759af-0d7f-6a87-e053-2a95a90acbd6	2024-12-20	Warnings	Exact identifier application number: M005
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Rugby Laboratories	a1365bc7-b376-adca-e053-2a95a90acf19	2024-12-20	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTIFUNGAL MICONAZOLE POWDER SPRAY	Premier Brands of America Inc.	dc7a23bb-b246-89b1-e053-2995a90a9f2d	2024-12-20	Warnings	Exact identifier application number: M005
Warrior Antifungal Foot	MICONAZOLE NITRATE 2%	Derma Care Research Labs, LLC	cf2e9dc1-275b-4454-e053-2995a90af295	2024-12-20	Warnings	Exact identifier application number: M005
Tolnaftate Cream 1%	TOLNAFTATE	Pharmacy Value Alliance, LLC.	3abfd734-229b-1a0e-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M005
Dermatool Fungal Nail Treatment	TOLNAFTATE 1%	Derma Care Research Labs, LLC	fbc1a55e-b994-4962-e053-6394a90a13ba	2024-12-19	Warnings	Exact identifier application number: M005
Novonail Solution	TOLNAFTATE 1%	Derma Care Research Labs, LLC	013d6107-e3b0-0264-e063-6394a90ae1e2	2024-12-19	Warnings	Exact identifier application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Rugby	f420de00-408f-9a2c-e053-2995a90adced	2024-12-17	Warnings	Exact identifier application number: M005
Relispray Antifungal Liquid	TOLNAFTATE	Midas-Care Pharmaceuticals Pvt. Ltd.	6522ad59-f810-408c-a9f9-9359d79302ce	2024-12-17	Warnings	Exact identifier application number: M005
Clotrimazole	FAMILY WELLNESS CLOTRIMAZOLE	Trifecta Pharmaceuticals USA LLC	915759af-0d7b-6a87-e053-2a95a90acbd6	2024-12-13	Warnings	Exact identifier application number: M005
Blistex Odor-Eaters Powder	TOLNAFTATE	Blistex Inc	819edb2f-dda7-45c3-b0da-ebcae354154e	2024-12-12	Warnings	Exact identifier application number: M005
Walgreens Athletes Foot	TOLNAFTATE SPRAY	Walgreens	c68ad65d-b016-0069-e053-2995a90ae7ef	2024-12-11	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