Soothe And Cool Treat

Product NDC: 53329-080
11-digit product format: 533290080
Labeler code: 53329
Product ID: 53329-080_e9c0d6a1-f897-61ae-e053-2995a90aeabc
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M005
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2007-01-01
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-080		D	Discontinued by firm	2026-10-05
excluded product	product	53329-080		D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-58	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-58	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 · 54 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-57	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-57	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-57	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-57	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-57	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-57	`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	53329-080-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-080-57	`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	53329-080-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-080-57	`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	53329-080-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-080-57	`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	53329-080-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-080-57	`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	53329-080-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-080-57	`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	53329-080-58	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-080-57	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-080-57	GM - Gram	53329-080	dd3c27b5-d2dd-4678-b9ef-191b3976fd37	1	2012-07-24
53329-080-58	GM - Gram	53329-080	67d5c4bd-053a-418b-83a8-efdce3b4539b	1	2012-07-24

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 26 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolnaftate	ODOR CONTROL POWDER SPRAY	Walgreen Company	a113f568-bd20-4f02-8e09-1b8223a0a9fa	2025-12-16	Warnings	Exact identifier application number: M005
Tobcharm Toenail Fungus Treatment Liquid	TOENAIL FUNGUS TREATMENT LIQUID	Guangzhou Qiexiran Cosmetics Co., Ltd.	45f92be2-0677-5989-e063-6394a90af280	2025-12-15	Warnings	Exact identifier application number: M005
TEA TREE Oil ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD	45bd3ad0-a0d1-314f-e063-6394a90a9a3a	2025-12-12	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Topco Associates LLC	97334166-1dff-4ed2-ad31-f524b22097f9	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Meijer Distribution Inc	03fd2680-0040-aa8c-e063-6294a90a090f	2025-12-12	Warnings	Exact identifier application number: M005
Foot Odor Control Powder	TOLNAFTATE	Premier Brands of America Inc.	edb0a2da-aaa1-3b9b-e053-2995a90a5012	2025-12-12	Warnings	Exact identifier application number: M005
Pedikleer	TOLNAFTATE	Rising Pharma Holdings, Inc.	83396c51-7107-4d98-9d80-ebf6584f4dc8	2025-12-11	Warnings	Exact identifier application number: M005
ELAIMEI FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	457d08eb-e812-8f12-e063-6294a90ab85f	2025-12-10	Warnings	Exact identifier application number: M005
Lofuanna FUNGAL NAIL PATCHES	TEA TREE OIL	Shenzhen Shandian Jingling Technology Co., Ltd.	43da9ec2-5f2f-dfce-e063-6394a90aecca	2025-12-10	Warnings	Exact identifier application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%	UNDECYLENIC ACID 25%	Shenzhen Shandian Jingling Technology Co., Ltd.	457f819b-0850-a97c-e063-6394a90ac368	2025-12-09	Warnings	Exact identifier application number: M005
NAIL REPAIR PEN	UNDECYLENIC ACID	Yunqi Cosmetics (Shenzhen) Co., Ltd	45814b84-0e51-6c9d-e063-6394a90a2905	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	MICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAY	Better Living Brands	ccfef81b-f271-4551-e053-2a95a90a8ac4	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE	Foodhold USA	a64c9371-0ac7-4c47-bc12-7bc77162b244	2025-12-09	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Harris Teeter, LLC	02eb9c78-5a89-4958-b5a4-68f39e584cf2	2025-12-09	Warnings	Exact identifier application number: M005
Bee Venom Toenail Fungus Treatment	BEE VENOM TOENAIL FUNGUS TREATMENT	Shenzhen Earth Surface Trading Co., Ltd.	457c705a-9c49-c8c5-e063-6394a90a6aa3	2025-12-08	Warnings	Exact identifier application number: M005
Tolnaftate Antifungal Powder	TOLNAFTATE	SCHOLL'S WELLNESS COMPANY LLC	2a0e006b-60b1-41b9-a5d2-ff0e34b48ff5	2025-12-06	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	1e7e74f6-9bca-48ab-804a-a7a81df3b608	2025-12-05	Warnings	Exact identifier application number: M005
Oiangna Tea Tree Oil Antifungal	CLOTRIMAZOLE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	453452a7-c613-6111-e063-6294a90aca81	2025-12-05	Warnings	Exact identifier application number: M005
Tinactin Antifungal	TOLNAFTATE	Bayer HealthCare LLC.	5f95be36-6efa-4dfb-9a40-88f4ce1de2b3	2025-12-05	Warnings	Exact identifier application number: M005
Tinactin	TOLNAFTATE	Bayer HealthCare LLC.	c3b715a9-233a-401a-ba60-f78c1ddf1ded	2025-12-05	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-080-57	53329008057	141 g in 1 TUBE (53329-080-57)	141 g	2007-01-01	0000-00-00	No	No	Current
53329-080-58	53329008058	56 g in 1 TUBE (53329-080-58)	56 g	2007-01-01	0000-00-00	No	No	Current