Anti-Fungal

Product NDC: 52000-061
Requested package NDC: 52000-061-01
11-digit product format: 520000061
Labeler code: 52000
Product ID: 52000-061_b60871ac-cbda-e21e-e053-2995a90ad8ca
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Universal Distribution Center LLC
Application: part333C
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-12-09
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 0 g/g
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52000-061	52000-061-01	I	Inactivated by FDA		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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52000-061	52000-061-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52000-061	52000-061-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
52000-061-01	2025-07-29	C162847	48780-1	3b156c62-314d-fb37-e063-e6dba90a4e07	Anti-Fungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52000-061-01	Anti-Fungal	1 in 1 BOX	CREAM	1		2
52000-061-01	Anti-Fungal	14 g in 1 TUBE	CREAM	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52000-061	ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]	2	Legacy NDC, 2 package rows	20241212_91a8d893-c51f-42de-8e7f-be496507fe7c.zip

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
998483	miconazole nitrate 2 % Topical Cream	PSN	91a8d893-c51f-42de-8e7f-be496507fe7c	2
998483	miconazole nitrate 20 MG/ML Topical Cream	SCD	91a8d893-c51f-42de-8e7f-be496507fe7c	2
998483	miconazole nitrate 2 % Topical Cream	SY	91a8d893-c51f-42de-8e7f-be496507fe7c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52000-061-01	52000006101	1 TUBE in 1 BOX (52000-061-01) > 14 g in 1 TUBE	1 tube	2020-12-09	0000-00-00	No	No	Current