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	2026-10-12
excluded product	product	53329-080		D	Discontinued by firm	2026-10-12
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-12
excluded package	package	53329-080	53329-080-58	D	Discontinued by firm	2026-10-12
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-12
excluded package	package	53329-080	53329-080-58	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 · 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 49 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Evercare Antifungal Treatment Super Absorbent Powder	MICONAZOLE NITRATE	PANEFFORT, LLC	f91910f3-b461-43a4-9120-fda69483fffa	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Clotrimazole	CLOTRIMAZOLE	FOURSTAR GROUP USA, INC.	1265be99-8922-4b76-bd63-19bfb42c3896	2023-10-26	Warnings	Exact identifier application number: M005
Thera plus Antifungal Tolnaftate	TOLNAFTATE	FOURSTAR GROUP USA, INC.	c628dda8-7a6d-5f3a-e053-2995a90a35f8	2023-10-26	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	e1789944-3a41-4c86-b173-3a6993ae2141	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Impregnated	POVIDONE IODINE	Jianerkang Medical Co., Ltd	b82cea56-b09f-411d-a6cf-c53b3ce0e3b6	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Scrub	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	78131b57-1ffc-4eb8-821e-f7bb73300fe9	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	eb30e5de-9074-4760-8e92-e1d1c127227d	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine	POVIDONE IODINE	Jianerkang Medical Co., Ltd	0bd3de76-b726-41f1-87bc-14ab8a1eca8e	2023-10-23	Warnings	Exact identifier application number: M005
Povidone Iodine Prep Pad	POVIDONE-IODINE	Jianerkang Medical Co., Ltd	be85ec5b-eb49-4f1a-a87d-5c9705a20f23	2023-10-22	Warnings	Exact identifier application number: M005
EVERLIT CARE Hand Sanitizer	ETHYL ALCOHOL	Nantong Health & Beyond Hygienic Products Inc.	579c1ab5-50b4-4b5a-a189-c1e2827d0c3a	2023-10-14	Warnings	Exact identifier application number: M005
Micomitin Antifungal	CLOTRIMAZOLE	PureTek Corporation	dd05f5f9-2412-1295-e053-2995a90acb96	2022-02-14	Warnings	Exact identifier application number: M005
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	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