Monistat 1 Combination Pack

Product NDC: 63736-001
11-digit product format: 637360001
Labeler code: 63736
Product ID: 63736-001_7dff99b6-bf15-475c-94db-331edee20da1
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: KIT
Labeler: Insight Pharmaceuticals
Application: NDA021308
Marketing category: NDA
Marketing start: 2001-06-29
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2019-12-31
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	63736-001		D	Discontinued by firm		2026-08-07
excluded package	package	63736-001	63736-001-01	D	Discontinued by firm		2026-08-07

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63736-001-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63736-001-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63736-001-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63736-001-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63736-001-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63736-001-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63736-001-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63736-001-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63736-001-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63736-001-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63736-001-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63736-001-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63736-001-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63736-001-01	2020-06-29	C162847	48780-1	9d75b9d0-9fdc-f424-e053-dadaa90a57ce	Monistat ® 1 Combination Pack Triple Action
63736-001-01	2020-01-31	C162847	48780-1	9d75b9d0-9fdc-f424-e053-dadaa90a57ce	Monistat ® 1 Combination Pack Triple Action

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	MONISTAT 1 COMBINATION PACK TRIPLE ACTION (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Monistat ® 1 Combination Pack Triple Action	Insight Pharmaceuticals LLC	2020-06-29	HUMAN OTC DRUG LABEL	3