Miconazole 3

Product NDC: 0363-5203
11-digit product format: 003635203
Labeler code: 0363
Product ID: 0363-5203_d536a071-d970-4dca-86d0-669dcc421ae6
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Route: VAGINAL
Labeler: WALGREEN COMPANY
Application: NDA020670
Marketing category: NDA
Marketing start: 2016-04-18
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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	0363-5203-01	`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
N020670-002	MONISTAT 3 COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL		RLD, RS	1996-04-16

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	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020670-002	MONISTAT 3 COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1996-04-16	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Miconazole 3
Brand name suffix: Walgreen Company
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992765	Internal RxNorm lookup
992766	Internal RxNorm lookup
998540	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
32b373be-9c8e-49b0-a796-8d87f6a20cef	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2026-01-20	Miconazole 3 Combination Pack
2026-01-20	Miconazole 3 Combination Pack - 0363-5203
2023-01-30	Miconazole 3 Combination Pack
2023-01-30	Miconazole 3 Combination Pack - 0363-5203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-5203-01	Miconazole 3Walgreen Company	1 in 1 PACKAGE, COMBINATION	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-5203	MICONAZOLE 3 WALGREEN COMPANY (MICONAZOLE NITRATE) KIT [WALGREEN COMPANY]	1	Current NDC, Legacy NDC, 1 package rows	20211110_32b373be-9c8e-49b0-a796-8d87f6a20cef.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3 Walgreen Company	MICONAZOLE NITRATE	WALGREEN COMPANY	32b373be-9c8e-49b0-a796-8d87f6a20cef	2026-07-21	Warnings	Exact identifier application applno (NDA): 020670 application number: NDA020670 ndc (product): 0363-5203
Monistat 3 Combination Pack 3 Ovule Inserts	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	2026-04-20	Warnings	Exact identifier application applno (NDA): 020670 application number: NDA020670
Miconazole 1 Combination Pack	MICONAZOLE NITRATE	CVS PHARMACY, INC	4cbf37d1-023d-496f-84c8-a1b2a83a10ef	2026-01-29	Warnings	Exact identifier application applno (NDA): 020670 application number: NDA020670
MONISTAT 3	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	674f2e66-e7e3-40ff-aa21-adaf5d55dcda	2025-11-04	Warnings	Exact identifier application applno (NDA): 020670 application number: NDA020670
Miconazole 3	MICONAZOLE NITRATE	CVS Pharmacy	6e027927-1532-46ba-8839-6ee4416d0b60	2017-01-06	Warnings	Exact identifier application applno (NDA): 020670 application number: NDA020670

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
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
998540	miconazole nitrate 2 % Vaginal Cream	PSN	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	32b373be-9c8e-49b0-a796-8d87f6a20cef	2
998540	miconazole nitrate 2 % Vaginal Cream	SY	32b373be-9c8e-49b0-a796-8d87f6a20cef	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-5203-01	00363520301	1 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBE	1 kit	2016-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Miconazole 3 Combination Pack - 0363-5203	WALGREEN COMPANY \| Insight Pharmaceuticals	2026-07-21	HUMAN OTC DRUG LABEL	3