Monistat 3 Combination Pack

Product NDC: 63736-019
11-digit product format: 637360019
Labeler code: 63736
Product ID: 63736-019_9fd5cf39-5662-42fa-8d8c-8b96dce19875
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: KIT
Labeler: Insight Pharmaceuticals LLC
Application: NDA020670
Marketing category: NDA
Marketing start: 1996-04-16
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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: Monistat 3 Combination Pack
Brand name suffix: 3 Ovule Inserts
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
992765	Internal RxNorm lookup
992766	Internal RxNorm lookup
992770	Internal RxNorm lookup
992771	Internal RxNorm lookup
998540	Internal RxNorm lookup
998541	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
910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	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
63736-019-03	Monistat 3 Combination Pack3 Ovule Inserts	1 in 1 PACKAGE, COMBINATION	KIT	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Miconazole Nitrate	ACTIVE INGREDIENT	VW4H1CYW1K	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Miconazole	ACTIVE MOIETY	7NNO0D7S5M	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Benzoic Acid	INACTIVE INGREDIENT	8SKN0B0MIM	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Potassium Hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63736-019	MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS (MICONAZOLE NITRATE) KIT [INSIGHT PHARMACEUTICALS LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240418_910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd.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
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 ndc (product): 63736-019
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
992771	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]	BPCK	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992766	{1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) / 3 (miconazole nitrate 200 MG Vaginal Insert) } Pack	GPCK	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998540	miconazole nitrate 2 % Vaginal Cream	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992765	miconazole nitrate 200 MG Vaginal Insert	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992766	miconazole nitrate 200 MG Vaginal Insert (3) / miconazole nitrate 2 % Vaginal Cream (9 GM) Pack	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998541	Monistat 2 % Vaginal Cream	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992770	Monistat 3 200 MG Vaginal Insert	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992771	Monistat 3 Day Ovule Combination Pack	PSN	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998541	miconazole nitrate 20 MG/ML Vaginal Cream [Monistat]	SBD	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992770	miconazole nitrate 200 MG Vaginal Insert [Monistat]	SBD	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998540	miconazole nitrate 20 MG/ML Vaginal Cream	SCD	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992765	miconazole nitrate 200 MG Vaginal Insert	SCD	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992771	{1 (0.32 OZ) (miconazole nitrate 2 % Vaginal Cream [Monistat]) / 3 (miconazole nitrate 200 MG Vaginal Insert [Monistat]) } Pack [Monistat 3 Day Ovule Combination Pack]	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992766	miconazole 3 Day (3 - 200 MG miconazole nitrate vaginal insert / 9 GM miconazole nitrate 2 % topical vaginal cream)	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992766	miconazole 3 Day Vaginal Insert Combination Pack	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998540	miconazole nitrate 2 % Vaginal Cream	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
998541	Monistat 20 MG/ML Vaginal Cream	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992770	Monistat 200 MG Vaginal Insert	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5
992771	Monistat 3 Day Ovule Combination Pack	SY	910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63736-019-03	63736001903	1 KIT in 1 PACKAGE, COMBINATION (63736-019-03) * 3 SUPPOSITORY in 1 KIT * 9 g in 1 TUBE	1 kit	1996-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MONISTAT 3 COMBINATION PACK_Ovule inserts-tube_63736-019-03	Insight Pharmaceuticals LLC	2026-04-20	HUMAN OTC DRUG LABEL	5