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 9 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LQNZJBAU Nail Repair Pen	UNDECYLENIC ACID	Guangzhou Xinhongda Trading Service Co., Ltd.	55236084-42f4-6ada-e063-6394a90ac846	2026-06-26	Warnings	Exact identifier application number: M005
VORVITA Nail Hardener	PANTHENOL,HYALURONIC ACID	HK Vorvita Technology Co., Limited	51d5d3c7-ca25-3ee5-e063-6294a90a3a05	2026-06-26	Warnings	Exact identifier application number: M005
natouch	MICONAZOLE	Natouch LLC	55210a9d-6c47-4fc7-e063-6294a90a3653	2026-06-25	Warnings	Exact identifier application number: M005
YEARCHOICE Fungal Nail Repair Pen	FUNGAL NAIL REPAIR PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	5500b582-0641-498d-e063-6394a90a3c58	2026-06-24	Warnings	Exact identifier application number: M005
FIobow FUNGAL NAIL TREATMENT	TOLNAFTATE 1% FUNGAL NAIL TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a49db2b-e45a-57c5-e063-6294a90a065c	2026-06-23	Warnings	Exact identifier application number: M005
RoyceDerm Antifungal .spray.	CLOTRIMAZOLE 1%	RoyceDerm LLC	54d3ae29-8919-4868-e063-6294a90a587e	2026-06-22	Warnings	Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT LIQUID	Walgreens Company	94f4f656-e8a3-4439-b53c-12be59dc8eac	2026-06-20	Warnings	Exact identifier application number: M005
VTROUY Fungal Nail Renewal Pen	FUNGAL NAIL RENEWAL PEN	Guangzhou Jingliang Cosmetics Co., Ltd.	549bf490-99c2-c800-e063-6394a90a672b	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree	TOLNAFTATE	Rida LLC	0c7a3b2d-8b1c-4130-86ad-892a59157480	2026-06-19	Warnings	Exact identifier application number: M005
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution	CLOTRIMAZOLE	Rida LLC	83a9c5dc-c969-43a7-a763-44783710d5d0	2026-06-18	Warnings	Exact identifier application number: M005
Anytalk FUNGAL NAIL TREATMENT	TOLNAFTATE 1%	Guangzhou Huixue Biotechnology Co., Ltd.	54718558-376f-ed31-e063-6294a90a5220	2026-06-17	Warnings	Exact identifier application number: M005
KLIPP FUNGAL NAIL TREATMENT	KLIPP FUNGAL NAIL TREATMENT	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	547f2fbe-a2de-057d-e063-6394a90ac742	2026-06-17	Warnings	Exact identifier application number: M005
GeriGentle Miconazole nitrate	ANTIFUNGAL	GERI-GENTLE CORPORATION	0ae03b4a-06c8-ddf9-e063-6294a90ad105	2026-06-16	Warnings	Exact identifier application number: M005
WKPIKI FUNGAL NAIL REPAIR PEN	UNDECYLENIC ACID 25% FUNGAL NAIL REPAIR PEN	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	54472c44-93de-d4b9-e063-6394a90adde1	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA Dermomucosal Antibacterial Gel	BIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GEL	Guangxi Rise Biological Technology Co.,Ltd.	5456574a-dda4-9c67-e063-6294a90ac222	2026-06-15	Warnings	Exact identifier application number: M005
BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL Solution	BIOSHUGA CUTANEOUS MUCOSAL ANTIMICROBIAL SOLUTION	Guangxi Rise Biological Technology Co.,Ltd.	5457a623-7812-e516-e063-6394a90a8bfd	2026-06-15	Warnings	Exact identifier application number: M005
TOYKNIER MULTI-PURPOSE TREATMENT	UNDECYLENIC ACID 25% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4f8eb3a3-8f26-50dd-e063-6294a90ad9f8	2026-06-14	Warnings	Exact identifier application number: M005
CYYZROSE ANTIFUNGAL NAIL	UNDECYLENIC ACID 25% ANTIFUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	527765d4-6988-ed4e-e063-6394a90a2f23	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGAL NAIL	TOLNAFTATE 1% FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a2317d2-e45b-1fe2-e063-6394a90a940d	2026-06-14	Warnings	Exact identifier application number: M005
HEALMUSZ FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a23c01b-492d-324b-e063-6394a90a73b1	2026-06-14	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