Miconazole 1

Product NDC: 0363-5201
11-digit product format: 003635201
Labeler code: 0363
Product ID: 0363-5201_4408940f-f908-4d58-ba9e-c42ec1e43339
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: KIT
Labeler: WALGREEN COMPANY
Application: NDA021308
Marketing category: NDA
Marketing start: 2021-11-30
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0363-5201		I	Inactivated by FDA		2026-08-11
excluded package	package	0363-5201	0363-5201-01	I	Inactivated by FDA		2026-08-11

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 · 30 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	0363-5201-01	`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	0363-5201-01	`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 package	package	0363-5201-01	`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 package	package	0363-5201-01	`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 package	package	0363-5201-01	`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 package	package	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`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	0363-5201-01	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021308-001	MONISTAT 1 COMBINATION PACK	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL		RLD, RS	2001-06-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021308-001	MONISTAT 1 COMBINATION PACK	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	RLD, RS	2001-06-29	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021308-001	6153635	2020-11-28	Delist requested	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021308-001	6153635	2020-11-28	Delist requested	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021308-001	6153635	2020-11-28	Delist requested	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021308-001	6153635	2020-11-28	Delist requested	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021308-001	6153635	2020-11-28	Delist requested	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021308-001	6153635	2020-11-28	Delist requested	`ea99ee380514…`

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
0363-5201-01	2023-01-30	C162847	48780-1	f386c649-da85-0266-e053-dadaa90a7c1a	Miconazole 1 Combination Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-5201-01	Miconazole 1Walgreens	1 in 1 PACKAGE, COMBINATION	KIT	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-5201	MICONAZOLE 1 WALGREENS (MICONAZOLE NITRATE) KIT [WALGREEN COMPANY]	4	Legacy NDC, 1 package rows	20211130_1fe7b02a-f60b-4572-b4e8-35bda290b176.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 1 Walgreens	MICONAZOLE NITRATE	WALGREEN COMPANY	9679f4a5-c27b-46ea-9983-c2a111d3d2c3	2026-05-06	Warnings	Exact identifier application applno (NDA): 021308 application number: NDA021308
Monistat 1 Combination Pack	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	97ff1c90-c250-4921-81af-6a56cc9cc7d2	2026-04-20	Warnings	Exact identifier application applno (NDA): 021308 application number: NDA021308
CVS MICONAZOLE 1 COMBINATION PACK	MICONAZOLE NITRATE	CVS PHARMACY, INC	db40f672-62b4-4844-a2d3-7e8617c40ec9	2026-03-24	Warnings	Exact identifier application applno (NDA): 021308 application number: NDA021308

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
992775	{1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack	GPCK	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
992775	miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack	PSN	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
992774	miconazole nitrate 1200 MG Vaginal Insert	PSN	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
998540	miconazole nitrate 2 % Vaginal Cream	PSN	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
992774	miconazole nitrate 1200 MG Vaginal Insert	SCD	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
992774	miconazole nitrate 1.2 GM Vaginal Insert	SY	1fe7b02a-f60b-4572-b4e8-35bda290b176	4
998540	miconazole nitrate 2 % Vaginal Cream	SY	1fe7b02a-f60b-4572-b4e8-35bda290b176	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-5201-01	00363520101	1 KIT in 1 PACKAGE, COMBINATION (0363-5201-01) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE	1 kit	2021-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Miconazole 1 Combination Pack	WALGREEN COMPANY \| Insight Pharmaceuticals	2021-08-30	HUMAN OTC DRUG LABEL	4