Miconazole Nitrate

Product NDC: 56104-121
11-digit product format: 561040121
Labeler code: 56104
Product ID: 56104-121_29b6fb49-f5fd-d406-e063-6294a90ace19
Type: HUMAN OTC DRUG
Nonproprietary name: Antifungal Miconazole Powder Spray
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: Premier Brands of America Inc.
Application: M005
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-04-12
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 · 18 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
2025-02-02 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	56104-121-01	`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	56104-121-01	`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	56104-121-01	`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	56104-121-01	`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	56104-121-01	`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	56104-121-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	56104-121-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	56104-121-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	56104-121-01	`1332a3947898…`	`d4bfe170f9cd…`

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
dc7a23bb-b246-89b1-e053-2995a90a9f2d	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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
56104-121-01	2025-02-25	C162847	48780-1	1030e365-5cd1-111a-e063-dadaa90a10e2	Soothing Feet Antifungal Miconazole Powder Spray
56104-121-01	2024-01-30	C162847	48780-1	1030e365-5cd1-111a-e063-dadaa90a10e2	Soothing Feet Antifungal Miconazole Powder Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
56104-121-01	Miconazole Nitrate	130 g in 1 CANISTER	AEROSOL, SPRAY	130		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56104-121	MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE POWDER SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250227_dc7a23bb-b246-89b1-e053-2995a90a9f2d.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 46 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	ASTONEA LABS PRIVATE LIMITED	e66191a6-0c3c-7319-e053-2a95a90aae84	2024-06-25	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	b63a3fe5-5684-41bc-ad6c-69c54e5b942d	2024-06-20	Warnings	Exact identifier application number: M005
THERA Antifungal Body	MICONAZOLE NITRATE	McKesson Medical-Surgical Inc.	31096041-28c9-4b16-bbd1-dbadefd37505	2024-06-14	Warnings	Exact identifier application number: M005
Antifungal Body	MICONAZOLE NITRATE	McKesson	4fb9aece-0baa-475e-e054-00144ff8d46c	2024-06-13	Warnings	Exact identifier application number: M005
Secura Protective	ZINC OXIDE	Smith & Nephew Medical Ltd	b077aa64-49a3-42ee-abb3-88f833635b93	2024-06-12	Warnings	Exact identifier application number: M005
clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	627375fb-2f20-16bc-e053-2a91aa0a1542	2024-06-06	Warnings	Exact identifier application number: M005
Clotrimazole	CLOTRIMAZOLE	Cardinal Health 110 dba LEADER	199df107-3384-6e03-e063-6294a90afc38	2024-05-29	Warnings	Exact identifier application number: M005
Femmesil	CLOTRIMAZOLE	Aidance Skincare & Topical Solutions, LLC	efddad82-9dc7-4cd9-b33c-7e85f30d992e	2024-05-24	Warnings	Exact identifier application number: M005
Anti-Fungal	MICONAZOLE NITRATE	Universal Distribution Center LLC	8f316b0d-d308-4ae6-82c4-39bb0d1d474e	2024-05-21	Warnings	Exact identifier application number: M005
CANESPIES	TOLNAFTATE	OPMX LLC	e2f9eedc-3c43-416b-85b5-ba07fb5fb4db	2024-05-17	Warnings	Exact identifier application number: M005
Up and Up Antifungal	TOLNAFTATE 1%	Target Corporation	8f54c8c7-6771-49c3-b429-53aa6df54dc5	2024-05-08	Warnings	Exact identifier application number: M005
Up and Up Athletes Foot	CLOTRIMAZOLE 1%	Target Corporation	52b61859-11ae-4990-aa0c-9dc1dd00adf4	2024-05-08	Warnings	Exact identifier application number: M005
ADI Medical PVP-I Pouch, Foil	POVIDONE-IODINE	Asia Dynamics Inc., d/b/a ADI Medical	0e8baf24-0c67-5511-e063-6394a90acaa1	2024-05-02	Warnings	Exact identifier application number: M005
Caseys Antimicrobial Hand Sanitizer	ETHYL ALCOHOL	Navajo Manufacturing Company Inc.	78863024-390c-4ff9-8ed6-02af07902a30	2024-04-29	Warnings	Exact identifier application number: M005
MQUPIN Liquid Fungal Nail Treatment	LIQUID FUNGAL NAIL TREATMENT	Zhengzhou Miaoqi Medical Technology Co., Ltd.	14782f8c-3b29-1d88-e063-6294a90ac3e4	2024-03-25	Warnings	Exact identifier application number: M005
ETADERM Advanced Antifungal Support	UNDECYLENIC ACID	NUEPHASE LLC	adb12a1c-ece9-4a59-a62c-89d212c57e6f	2024-03-13	Warnings	Exact identifier application number: M005
Dermachange Jock	MICONAZOLE NITRATE	Private label Beauty and Wellness	12eef049-76c9-1450-e063-6394a90a00ea	2024-03-05	Warnings	Exact identifier application number: M005
Clotrimazole Antifungal	CLOTRIMAZOLE	Trifecta Pharmaceuticals USA, LLC.	11bf50db-552e-0a39-e063-6394a90af60d	2024-02-19	Warnings	Exact identifier application number: M005
TOLNAFTATE ANTIFUNGAL	TOLNAFTATE	Bryant Ranch Prepack	fbbd159c-217e-46d3-963c-ba0bd1e9bbe8	2024-01-29	Warnings	Exact identifier application number: M005
Target Jock Itch	CLOTRIMAZOLE 1%	Target Corporation	f44d4c44-99d1-413f-b9c3-8330bdd21abb	2024-01-17	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	dc7a23bb-b246-89b1-e053-2995a90a9f2d	4
998428	miconazole nitrate 0.02 MG/MG Powder Spray	SCD	dc7a23bb-b246-89b1-e053-2995a90a9f2d	4
998428	miconazole nitrate 2 % Powder Spray	SY	dc7a23bb-b246-89b1-e053-2995a90a9f2d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56104-121-01	56104012101	130 g in 1 CANISTER (56104-121-01)	130 g	2022-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Soothing Feet Antifungal Miconazole Powder Spray	Premier Brands of America Inc.	2024-12-20	HUMAN OTC DRUG LABEL	4