Miconazole 1

Product NDC: 59779-737
Requested package NDC: 59779-737-45
11-digit product format: 597790737
Labeler code: 59779
Product ID: 59779-737_a86c00d8-8593-4308-a88d-dbfc000b141b
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole nitrate
Dosage form: KIT
Labeler: CVS Pharmacy
Application: ANDA079114
Marketing category: ANDA
Marketing start: 2010-06-08
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59779-737	59779-737-45	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A079114-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL			2010-06-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2010-06-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079114-001	MICONAZOLE NITRATE	2%,1.2GM	CREAM, INSERT / TOPICAL, VAGINAL	2010-06-02	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-737-45	EA - Each	59779-737	422a30e2-1734-4e60-8eff-2efb0c541e2c	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MICONAZOLE NITRATE	ACTIVE INGREDIENT	VW4H1CYW1K	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
MICONAZOLE	ACTIVE MOIETY	7NNO0D7S5M	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
IODOPROPYNYL BUTYLCARBAMATE	INACTIVE INGREDIENT	603P14DHEB	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
PEG-5 OLEATE	INACTIVE INGREDIENT	0240V77G50	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
PEG-75 LANOLIN	INACTIVE INGREDIENT	09179OX7TB	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
PEGOXOL 7 STEARATE	INACTIVE INGREDIENT	3EW5AXE5X5	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	MICONAZOLE 1 (MICONAZOLE NITRATE) KIT [CVS PHARMACY]	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOSTER AND THRIVE MICONAZOLE 1	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	0d3fcb1a-54dd-49b7-b776-4366fc2147b3	2025-10-01	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
equate miconazole 1	MICONAZOLE NITRATE	Wal-Mart Stores Inc	5c5b0486-9ec2-4e14-a35c-80da8e62c59e	2025-07-02	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	Meijer Distribution Inc	c34d9917-ee79-4afb-9338-6f18e63b2b09	2025-01-13	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
up and up miconazole	MICONAZOLE NITRATE	Target Corporation	b626313a-b8aa-43fe-b8a9-475009ea5b53	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	Kroger Company	11878a63-93e7-464f-97fc-54899884d7fe	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
topcare miconazole 1	MICONAZOLE NITRATE	Topco Associates LLC	8138de63-c7e9-4b2c-a0e2-c62292a0b320	2024-12-11	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1 yeast infection relief	MICONAZOLE NITRATE	CVS Pharmacy	b0e5320b-73d5-4e96-8ce4-9a858e9d2ed3	2024-12-10	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Basic Care Miconazole	MICONAZOLE NITRATE	Amazon.com Services LLC	962bef75-1583-4782-bfba-52a68876eedc	2024-11-04	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
careone miconazole 1	MICONAZOLE NITRATE	American Sales Company	f51af8e2-fb06-4842-8021-b7efd515022e	2023-10-23	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
exchange select miconazole 1	MICONAZOLE NITRATE	Army & Air Force Exchange Service	672d935f-0807-44d1-8faa-94d416907095	2022-11-29	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Signature Care Miconazole 1	MICONAZOLE NITRATE	Safeway	5129e042-421e-41e3-a0be-90f12d12b40b	2022-11-15	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
miconazole 1	MICONAZOLE NITRATE	H E B	40cc911b-2c35-4382-a979-fb1a165049db	2022-11-12	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114
Good Neighbor Pharmacy Miconazole 1	MICONAZOLE NITRATE	Amerisource Bergen	12c400dc-4fbf-4a10-9a4d-5156d65b509a	2022-11-09	Warnings	Exact identifier application applno (ANDA): 079114 application number: ANDA079114

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	Miconazole nitrate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-737-45	59779073745	1 KIT in 1 CARTON (59779-737-45) * 3 POUCH in 1 PACKAGE > 1 SWAB in 1 POUCH * 9 g in 1 TUBE * 1 INSERT in 1 BLISTER PACK	1 kit	2010-06-08	0000-00-00	No	No	Current