Miconazole Nitrate

Product NDC: 55315-815
11-digit product format: 553150815
Labeler code: 55315
Product ID: 55315-815_a97a84b3-99ed-4470-91f0-dc519360d24f
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: VAGINAL
Labeler: FRED'S, INC.
Application: ANDA074444
Marketing category: ANDA
Marketing start: 1997-01-13
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/g
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55315-815		I	Inactivated by FDA		2026-08-17
excluded package	package	55315-815	55315-815-63	I	Inactivated by FDA		2026-08-17

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 · 4 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 package	package	55315-815-63	`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 package	package	55315-815-63	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074444-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1997-01-13

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
55315-815-63	2025-07-29	C162847	48780-1	3b156c62-270f-fb37-e063-e6dba90a4e07	Miconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55315-815-63	Miconazole Nitrate	45 g in 1 TUBE, WITH APPLICATOR	CREAM	45		1
55315-815-63	Miconazole Nitrate	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55315-815	MICONAZOLE NITRATE CREAM [FRED'S, INC.]	1	Legacy NDC, 2 package rows	20190221_d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22.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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	6b34d0be-4bcd-4dff-b732-7fbd46765019	2026-08-25	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	a32fc37b-bcad-4f56-8dc6-cf36a6716196	2026-02-19	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole 7	MICONAZOLE NITRATE	TARGET Corporation	edaca770-bc76-4ac2-bad2-cf8e7de0c682	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444
Miconazole 7	MICONAZOLE NITRATE	CVS Pharmacy	5e7e4cf8-24ec-486e-9389-546ffea004d0	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444

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
998540	miconazole nitrate 2 % Vaginal Cream	PSN	d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22	1
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22	1
998540	miconazole nitrate 2 % Vaginal Cream	SY	d91714a5-20a6-4f0b-ba97-5c9e5f0dfc22	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55315-815-63	55315081563	1 TUBE, WITH APPLICATOR in 1 CARTON (55315-815-63) > 45 g in 1 TUBE, WITH APPLICATOR	2019-02-14	0000-00-00	No	No	Current