Monistat 7 Combination Pack

Product NDC: 63736-023
11-digit product format: 637360023
Labeler code: 63736
Product ID: 63736-023_c4195b56-36a3-4584-8d1c-3aed7c4bbbbd
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: KIT
Labeler: Insight Pharmaceuticals LLC
Application: NDA017450
Marketing category: NDA
Marketing start: 1993-04-26
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N017450-002	MONISTAT 7	MICONAZOLE NITRATE	2%	CREAM / VAGINAL		RLD, RS	1991-02-15

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	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017450-002	MONISTAT 7	2%	CREAM / VAGINAL	RLD, RS	1991-02-15	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Monistat 7 Combination Pack
Brand name suffix: 7-Day Pre-Filled Applicators
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
998540	Internal RxNorm lookup
998541	Internal RxNorm lookup
1536610	Internal RxNorm lookup
1854816	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
9b1ac735-9b18-48c2-86dc-93d07157d5e5	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63736-023-15	Monistat 7 Combination Pack7-Day Pre-Filled Applicators	1 in 1 PACKAGE, COMBINATION	KIT	1		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-023	MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241109_9b1ac735-9b18-48c2-86dc-93d07157d5e5.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
Monistat 7 with Reusable Applicator	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	2aad40f2-4eea-441d-8b34-5613f1955405	2025-10-27	Warnings	Exact identifier application applno (NDA): 017450 application number: NDA017450
Monistat 7 Combination Pack 7-Day Pre-Filled Applicators	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	9b1ac735-9b18-48c2-86dc-93d07157d5e5	2025-08-22	Warnings	Exact identifier application applno (NDA): 017450 application number: NDA017450 ndc (product): 63736-023
MONISTAT 7 7-DAY DISPOSABLE APPLICATORS	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	c4b68aff-e95f-47ae-b190-6a671bef1877	2024-11-12	Warnings	Exact identifier application applno (NDA): 017450 application number: NDA017450

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
1536610	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 7 (5000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) } Pack [Monistat 7 Vaginal Cream Combination Pack with Vaginal Creams]	BPCK	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
1854816	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 7 (5000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack	GPCK	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
1854816	miconazole 7 Day - (2 % applicator 5 GM / 2 % cream 9 GM) Pack	PSN	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998540	miconazole nitrate 2 % Vaginal Cream	PSN	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998541	Monistat 2 % Vaginal Cream	PSN	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
1536610	Monistat 7 Vaginal Cream Combination Pack with Prefilled Applicators	PSN	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998541	miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]	SBD	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
1854816	miconazole 7 Day Prefilled Applicator Combination Pack	SY	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998540	miconazole nitrate 2 % Vaginal Cream	SY	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
998541	Monistat 20 MG/ML Vaginal Cream	SY	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6
1536610	Monistat 7 Vaginal Cream Combination Pack with Prefilled Applicators	SY	9b1ac735-9b18-48c2-86dc-93d07157d5e5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-023-15	63736002315	1 KIT in 1 PACKAGE, COMBINATION (63736-023-15) * 5 g in 1 TUBE, WITH APPLICATOR * 9 g in 1 TUBE	1 kit	1993-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Monistat 7 Cure Itch Relief - PreFilledApps-Cream	Insight Pharmaceuticals LLC	2025-08-22	HUMAN OTC DRUG LABEL	6