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 19 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natouch Antifungal Antiseptic Wipes	ANTIFUNGAL ANTISEPTIC WIPES	Natouch LLC	4c84c556-8d0b-ec28-e063-6294a90af1d3	2026-03-08	Warnings	Exact identifier application number: M005
ANTIFUNGAL Cream	ANGELICA DAHURICA EXTRACTT, ASIATIC ACID	Guangzhou Mizi Biotechnology Co., LTD.	4c586cd9-d356-34d8-e063-6294a90a4d11	2026-03-06	Warnings	Exact identifier application number: M005
FungiFoam	TOLNAFTATE	The Tetra Corporation	2449e8e5-9d7e-4119-9e7a-378efe55f875	2026-03-06	Warnings	Exact identifier application number: M005
RoyceDerm ANTIFUNGAL .soap.	CLOTRIMAZOLE 1%	RoyceDerm LLC	4c43e62b-9060-8962-e063-6394a90aff63	2026-03-05	Warnings	Exact identifier application number: M005
Derman Antifungal	TOLNAFTATE	Compania Internacional de Comercio, S.A.P.I. de C.V.	5784a783-1056-4d50-8d87-2df4f8e16b09	2026-03-05	Warnings	Exact identifier application number: M005
Antifungal Powder	TOLNAFTATE	ARMY & AIR FORCE EXCHANGE SERVICE	4c39e121-4919-a482-e063-6294a90a98cd	2026-03-04	Warnings	Exact identifier application number: M005
ViLLsure Antifungal Pen	UNDECYLENIC ACID 25%ANTIFUNGAL PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	4c28cf04-94ad-8db6-e063-6394a90a2eed	2026-03-03	Warnings	Exact identifier application number: M005
ProClearz Maximum Strength Fungal Shield Brush-on Antifungal	TOLNAFTATE	Rooftop Consumer Health, Inc.	4d451e87-c25b-49cf-92b8-747b053930c2	2026-03-02	Warnings	Exact identifier application number: M005
HAND SANITIZER lsland Coconut	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf3a822-27d2-efef-e063-6294a90a0502	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cherry Blossom	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf48a93-345d-b901-e063-6394a90ab41b	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Cucumber Melon	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf552a4-b8b3-6fe3-e063-6394a90a722a	2026-03-01	Warnings	Exact identifier application number: M005
HAND SANITIZER Watermelon Sugar	ALCOHOL HAND SANITIZER	PT SUPER HOME PRODUCT INDONESIA	4bf57b6e-c271-b4c6-e063-6394a90a63c6	2026-03-01	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	e0a2a907-9c3a-4c4e-e053-2995a90abb91	2026-03-01	Warnings	Exact identifier application number: M005
FOLUPIA FUNGAL NAIL RENEWAL	FOLUPIA FUNGAL NAIL RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4bcacd53-9446-67ec-e063-6294a90a209e	2026-02-27	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	d6f5c6b5-5e56-462f-8c47-7986ce53669d	2026-02-25	Warnings	Exact identifier application number: M005
Lakeim FUNGAL NAIL RENEWAL Kit	FUNGAL NAIL RENEWAL KIT	Guangzhou Jingliang Cosmetics Co., Ltd.	4b6aae50-b219-beee-e063-6394a90ab415	2026-02-22	Warnings	Exact identifier application number: M005
Hermon Jock Itch spray.	MICONAZOLE NITRATE 2%	Beautivity LLC	4b633528-667a-f34e-e063-6294a90a2b3d	2026-02-21	Warnings	Exact identifier application number: M005
Lakeim Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	4b23c3a6-51da-7875-e063-6394a90a1467	2026-02-18	Warnings	Exact identifier application number: M005
OSIMOON FUNGAL NAIL RENEWAL	FUNGAL NAIL RENEWAL	Guangzhou Jingliang Cosmetics Co., Ltd.	4b113f31-1a82-a3ca-e063-6394a90a3231	2026-02-17	Warnings	Exact identifier application number: M005
Hermon Ringworm Antifungal soap.	CLOTRIMAZOLE 1%	Beautivity LLC	48405a7c-14cd-b3a0-e063-6394a90a9fc9	2026-02-13	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