Miconazole Nitrate

Product NDC: 41520-565
11-digit product format: 415200565
Labeler code: 41520
Product ID: 41520-565_458ac437-bfd6-73c7-e063-6294a90afc9b
Type: HUMAN OTC DRUG
Nonproprietary name: Anti-fungal Miconazole Athletes Foot Spray Talc Free
Dosage form: AEROSOL, POWDER
Route: TOPICAL
Labeler: Foodhold USA
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-10-20
Substance: MICONAZOLE NITRATE
Active strength: 2.6 g/130g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 8 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	41520-565-46	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	41520-565-46	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	41520-565-46	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	41520-565-46	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Miconazole Nitrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICONAZOLE NITRATE	2.6 g/130g

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
998428	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
a64c9371-0ac7-4c47-bc12-7bc77162b244	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866a	Product name	1	20140508
5b9a7965-36d2-8412-dcaf-f76a65411611	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-01-12	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2023-01-12	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2023-01-12	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free
2021-07-23	CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-565-46	Miconazole Nitrate	130 g in 1 CAN	AEROSOL, POWDER	130		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-565	MICONAZOLE NITRATE (ANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREE) AEROSOL, POWDER [FOODHOLD USA]	5	Current NDC, Legacy NDC, 1 package rows	20241109_a64c9371-0ac7-4c47-bc12-7bc77162b244.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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velloryn ANTIFUNGAL Cream	ZINC UNDECYLENATE, UNDECYLENIC ACID	Guangdong Quadrant Ecological Technology Co., Ltd.	4e38e1f1-0466-5b91-e063-6294a90a66c4	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Daytime Antigungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3d226b-57f1-75a6-e063-6394a90a96cd	2026-03-30	Warnings	Exact identifier application number: M005
APUREE Nailtific Extra-Max Strength Nighttime Antifungal	APUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGAL	Guangzhou Meixi Biotechnology Co., Ltd.	4e3e8895-34b4-de69-e063-6294a90a5532	2026-03-30		Exact identifier application number: M005
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	CVS Pharmacy	3380263d-ee7b-4946-a467-35a24789a901	2026-03-27	Warnings	Exact identifier application number: M005
Micro-Guard (AF)	MICONAZOLE NITRATE	Coloplast Corp	a43a94d0-fec0-470f-bdb4-535dcce6d1e0	2026-03-27	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Fresh Citrus	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d77ec6-a1d1-13dc-e063-6394a90a95f4	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Deeply Clean	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d83736-66da-abb9-e063-6294a90a3d67	2026-03-26	Warnings	Exact identifier application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe Vera	LIQUID HAND WASH ANTIBACTERIAL	Suave Brands Co, LLC	41d8848c-d157-6e2c-e063-6294a90aa259	2026-03-26	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch	ANTIFUNGAL TREATMENT KIT	Beautivity LLC	4800a93b-7042-827b-e063-6294a90acd95	2026-03-25	Warnings	Exact identifier application number: M005
Toenail Fungus Treatment	TERBINAFINE	Shenzhen Wankelai E-commerce Co., Ltd.	4dc1d7f7-e4ae-c54b-e063-6394a90aa420	2026-03-24	Warnings	Exact identifier application number: M005
Lasolex Liquid Solution	CLOTRIMAZOLE 1%	PureTek Corporation	4dc9e64d-8235-b218-e063-6394a90a0157	2026-03-24	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. Bar	TOLNAFTATE 1%	Beautivity LLC	4dbbf09b-5bc1-501b-e063-6394a90a2a9d	2026-03-23	Warnings	Exact identifier application number: M005
Hermon Jock Itch Antifungal Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4dbc521c-2f5f-9736-e063-6294a90ad85d	2026-03-23	Warnings	Exact identifier application number: M005
seebeellar clotrimazole 1% antifungal cream	SEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	4d80e551-76c2-150a-e063-6394a90a7996	2026-03-20	Warnings	Exact identifier application number: M005
Nail Fungal Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5b5c22-4781-6391-e063-6294a90a7010	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MADRID MUSE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5cecf6-c232-6cd9-e063-6394a90a03e9	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER VALENCIA VIBES	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5de4d6-4c58-f393-e063-6294a90a323a	2026-03-19	Warnings	Exact identifier application number: M005
Toenail Fungus Pen	UNDECYLENIC ACID	Guangzhou Hechuang Commercial Service Co.,Ltd.	4d5e256f-7fd5-f903-e063-6394a90a1160	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MALLORCA BREEZE	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d5e50de-62fd-f9e9-e063-6394a90af0bd	2026-03-19	Warnings	Exact identifier application number: M005
HAND SANITIZER MAR BELLA	ALCOHOL HAND SANITIZER	CROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.	4d6005d9-5d4d-033e-e063-6294a90ad36f	2026-03-19	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
998428	miconazole nitrate 2 % Powder Spray	PSN	a64c9371-0ac7-4c47-bc12-7bc77162b244	7
998428	miconazole nitrate 0.02 MG/MG Powder Spray	SCD	a64c9371-0ac7-4c47-bc12-7bc77162b244	7
998428	miconazole nitrate 2 % Powder Spray	SY	a64c9371-0ac7-4c47-bc12-7bc77162b244	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-565-46	41520056546	130 g in 1 CAN (41520-565-46)	130 g	2017-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CareOne Miconazole Antifungal Athlete's Foot Powder Spray Talc-Free	Foodhold USA	2025-12-09	HUMAN OTC DRUG LABEL	7